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ST. JUDE MEDICAL, INC.

Last updated May 24, 2026

What ST. JUDE MEDICAL, INC. makes

The company manufactures single-use and reusable vascular and cardiac devices, including catheter introduction sets, guide-catheters, and guidewires for vascular and peripheral procedures. It also produces mechanical heart valve prostheses, mitral and tricuspid annuloplasty rings for open-heart surgery, cardiac defect occluders, pacing/defibrillation lead stylets, and electrical connection cables for medical devices.

The portfolio includes devices classified as Class I, Class II, and Class III under regulatory frameworks, with several listed in the FDA’s Unique Device Identifier (UDI) database. The company operates primarily from the United States, where these products are subject to U.S. medical device regulations.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does St. Jude Medical, Inc. manufacture?

St. Jude Medical, Inc. specializes in vascular and cardiac devices. Their portfolio includes single-use and reusable products like vascular catheter introduction sets, guide-catheters, and guidewires for vascular and peripheral procedures. They also produce mechanical heart valve prostheses, mitral and tricuspid annuloplasty rings for open-heart surgery, cardiac defect occluders, pacing/defibrillation lead stylets, and electrical connection cables for medical devices. These devices are designed for procedures ranging from minimally invasive interventions to open-heart surgeries.

Where is St. Jude Medical, Inc. based, and how does that affect its devices?

St. Jude Medical, Inc. is based in the United States, which means its devices are subject to U.S. medical device regulations. The company’s products are designed and manufactured under these regulatory frameworks, ensuring compliance with U.S. standards for safety, performance, and quality. This includes adherence to requirements like the FDA’s Unique Device Identifier (UDI) database for traceability and transparency.

Which regulatory registries list St. Jude Medical, Inc.’s devices?

St. Jude Medical, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their distribution and use, ensuring better monitoring of device performance, safety, and compliance. This registry helps healthcare providers, regulators, and manufacturers maintain accurate records of device information.

How are St. Jude Medical, Inc.’s devices classified under regulatory frameworks?

St. Jude Medical, Inc.’s devices are classified into three regulatory categories: Class I, Class II, and Class III. Class I devices generally pose the lowest risk, such as simple tools or reusable cables. Class II devices require special controls to ensure safety and effectiveness, like certain vascular guide-catheters. Class III devices, which include high-risk products like mechanical heart valve prostheses and cardiac defect occluders, require pre-market approval due to their significant risk potential and lack of less risky alternatives.

What kinds of devices in St. Jude Medical, Inc.’s portfolio are used in open-heart surgeries?

St. Jude Medical, Inc. manufactures devices specifically designed for open-heart surgeries, including mitral and tricuspid annuloplasty rings. These rings are used to repair valve leaflets and restore proper heart function during surgical procedures. The company’s portfolio also includes mechanical heart valve prostheses, which are implanted to replace damaged or diseased heart valves, ensuring continued blood flow through the heart.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: sjm.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(855)478-5833
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 149818952

Catalogue (2538)

Page 1 of 51

Device	Model / Reference	Registries	Class	Status
Agilis™	G408321	FDA UDI	Class II	Active
SJM™ Masters Series HP	27AHPJ-505	FDA UDI	Class III	Active
Amplatzer™ Talisman™	9-PFO-2518	FDA UDI	Class III	Active
Amplatzer™	9-PDA2-05-04	FDA UDI	Class III	Active
Durata™	7120Q-65	FDA UDI	Class III	Active
Sjm™	406420	FDA UDI	Class II	Unknown
Ellipse™	CD2411-36QC	FDA UDI	Class III	Active
Swartz™	407452	FDA UDI	Class II	Active
GuideRight™	404550	FDA UDI	Class II	Unknown
FlexAbility™	A701128	FDA UDI	Class III	Active
Sjm™	4090/46	FDA UDI	Class II	Active
Wi-Fi™	EX3213	FDA UDI	Class III	Active
Engage™	C408515	FDA UDI	Class II	Active
Procure™	408299	FDA UDI	Class II	Active
SJM Tailor™	TAB-31	FDA UDI	Class II	Active
Fast-Cath™	406303	FDA UDI	Class II	Active
Tendyne™	TENDV-SP-33M	FDA UDI	Class III	Active
Procure™	408294	FDA UDI	Class II	Active
Ultimum™	407854	FDA UDI	Class II	Active
Ep-4™	H21911	FDA UDI	Class II	Active
Quadra Assura Mp™	CD3369-40	FDA UDI	Class III	Active
Quantien™	Measurement System	FDA UDI	Class II	Active
EnSite™	Velocity System	FDA UDI	Class II	Active
Ultimum™	407659	FDA UDI	Class II	Active
SJM Tailor™	TAB-33	FDA UDI	Class II	Active
Endurity™	PM1160	FDA UDI	Class III	Active
Masters Series™	23CAVGJ-514 00	FDA UDI	Class III	Active
Engage™	C408516	FDA UDI	Class II	Active
Locator™	1281-52	FDA UDI	Class III	Active
Sjm™	SARP-28	FDA UDI	Class II	Active
Swift-Lock™	1192	FDA UDI	Class II	Active
EnSite™	Velocity ArrayLink	FDA UDI	Class II	Active
Ultimum™	407855	FDA UDI	Class II	Active
Optisure™	LDA230Q-58	FDA UDI	Class III	Active
Cps™	Implant Kit	FDA UDI	Class II	Unknown
GuideRight™	405015	FDA UDI	Class II	Unknown
Epic™	E100-23A-00	FDA UDI	Class III	Active
Durata™	7121-60	FDA UDI	Class III	Active
A127™	2343	FDA UDI	Class III	Active
EnSite™	ENSITE-FF-BRCKT-01	FDA UDI	Class II	Active
Tendyne™	TENDV-SPAD	FDA UDI	Class III	Active
Quadra Assura Mp™	CD3369-40Q	FDA UDI	Class III	Active
Promote™	CD3211-36Q	FDA UDI	Class III	Active
VantageView™	H700470	FDA UDI	Class II	Active
PressureWire™	C17040	FDA UDI	Class II	Active
Amplatzer™ TorqVue™	9-TVLP5F90/080	FDA UDI	Class II	Active
Cps Direct™	PL	FDA UDI	Class II	Active
Bedrail Clamp	Bedrail Clamp	FDA UDI	Class III	Active
Amplatzer™ TorqVue™	9-TV2-06F120	FDA UDI	Class II	Active
GuideRight™	405050	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Authorities

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FDA Recalls (79)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

St. Jude Medical, Inc. has 79 recall records spanning from December 9, 2008, to February 3, 2025, with statuses including open, classified, and terminated. Reasons for recalls include device malfunctions such as battery weld failures, communication errors, battery voltage drops from temperature exposure, and firmware inaccuracies in battery longevity estimates. Additional recalls address distribution errors, labeling discrepancies, potential material composition deviations, and security vulnerabilities in firmware updates for implantable cardiac devices and neuromodulation systems.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 3, 2025	Z-1427-2025	—	open, classified	Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
Nov 6, 2024	Z-0987-2025	—	open, classified	Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
Oct 5, 2024	Z-0988-2025	—	open, classified	As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Oct 5, 2024	Z-0989-2025	—	open, classified	As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Apr 30, 2024	Z-2348-2024	—	open, classified	One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Oct 4, 2023	Z-0218-2024	—	open, classified	Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Feb 7, 2023	Z-1225-2023	—	open, classified	Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
Feb 7, 2023	Z-1218-2023	—	open, classified	Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).
Feb 7, 2023	Z-1223-2023	—	open, classified	Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
Feb 7, 2023	Z-1219-2023	—	open, classified	Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).
Feb 7, 2023	Z-1220-2023	—	open, classified	Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).
Feb 7, 2023	Z-1221-2023	—	open, classified	Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).
Feb 7, 2023	Z-1224-2023	—	open, classified	Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
Jun 20, 2019	Z-2070-2019	—	terminated	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Jun 20, 2019	Z-2073-2019	—	terminated	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Jun 20, 2019	Z-2071-2019	—	terminated	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Jun 20, 2019	Z-2072-2019	—	terminated	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Jun 20, 2019	Z-2075-2019	—	terminated	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Jun 20, 2019	Z-2074-2019	—	terminated	Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Oct 11, 2018	Z-0593-2019	—	terminated	The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
Apr 16, 2018	Z-2328-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2325-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2324-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2321-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2319-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2335-2018	—	terminated	The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
Apr 16, 2018	Z-2329-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2323-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2326-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2322-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2327-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2334-2018	—	terminated	The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
Apr 16, 2018	Z-2318-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Apr 16, 2018	Z-2320-2018	—	terminated	The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Mar 9, 2018	Z-1170-2018	—	terminated	The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.
Sep 12, 2017	Z-0022-2018	—	terminated	Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Sep 12, 2017	Z-0023-2018	—	terminated	Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Sep 12, 2017	Z-0024-2018	—	terminated	Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Aug 28, 2017	Z-0031-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0030-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0038-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0035-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0033-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0037-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0034-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0032-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0004-2018	—	terminated	The device may exhibit premature battery depletion.
Aug 28, 2017	Z-0029-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0036-2018	—	terminated	New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Aug 28, 2017	Z-0003-2018	—	terminated	The device may exhibit premature battery depletion.
Jun 2, 2017	Z-2692-2017	—	terminated	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Jun 2, 2017	Z-2694-2017	—	terminated	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Jun 2, 2017	Z-2696-2017	—	terminated	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Jun 2, 2017	Z-2695-2017	—	terminated	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Jun 2, 2017	Z-2691-2017	—	terminated	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Jun 2, 2017	Z-2693-2017	—	terminated	The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Oct 10, 2016	Z-0115-2017	—	terminated	St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Oct 10, 2016	Z-0116-2017	—	terminated	St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Oct 10, 2016	Z-0117-2017	—	terminated	St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Mar 31, 2016	Z-1632-2016	—	terminated	St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.
Jul 29, 2014	Z-2718-2014	—	terminated	The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
Jul 29, 2014	Z-2719-2014	—	terminated	The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
Oct 11, 2013	Z-0174-2014	—	terminated	St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).
Oct 11, 2013	Z-0187-2014	—	terminated	St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.
Jan 18, 2013	Z-0763-2013	—	terminated	The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.
Nov 30, 2012	Z-1785-2013	—	terminated	There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the
Jul 26, 2012	Z-1739-2013	—	terminated	St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica
Jul 26, 2012	Z-1836-2013	—	terminated	As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanne
Jul 26, 2012	Z-1738-2013	—	terminated	St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica
Mar 28, 2012	Z-0617-2013	—	terminated	St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
Jan 5, 2012	Z-1032-2012	—	terminated	Two St Jude Medical 1500T9 RF Generator units were distributed to customers while still under FDA review as part of a PMA supplement to the approved PMA applications.
Jun 1, 2011	Z-2955-2011	—	terminated	St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. Jude Medical has determined that the incorrectly labeled product poses no safety risk since the extension cable can be safely used with a corresponding Quadripolar catheter but cannot be incorrectly connected to a Hexapolar catheter.
Aug 17, 2009	Z-2229-2009	—	terminated	St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another case, the carton label is incorrect. The pouch label indicated that the product was 4F catheter, but the contents of the pouch may be a 7F catheter. St. Jude Medical has not received any reports of injuries resulting from this mis-labeling.
Aug 17, 2009	Z-2228-2009	—	terminated	St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another case, the carton label is incorrect. The pouch label indicated that the product was 4F catheter, but the contents of the pouch may be a 7F catheter. St. Jude Medical has not received any reports of injuries resulting from this mis-labeling.
Jun 24, 2009	Z-1713-2009	—	terminated	St. Jude Medical has initiated a voluntary recall of two lots of Peel l Away Introducers . Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the outer box label. Some 9F products have been labelled as 7F and vice versa. Only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product. St Jude Medical has not received any reports of injures resulting from this mislabelling to date.
Jun 24, 2009	Z-1714-2009	—	terminated	St. Jude Medical has initiated a voluntary recall of two lots of Peel Away Introducers . Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the outer box label. Some 9F products have been labelled as 7F and vice versa. Only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product. St Jude Medical has not received any reports of injures resulting from this mislabelling to date.
Mar 23, 2009	Z-1422-2009	—	terminated	Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 calls for both lines to be fused.
Feb 13, 2009	Z-1156-2009	—	terminated	Installation problem: there is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.
Dec 9, 2008	Z-0946-2009	—	terminated	Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.