St. Jude Medical Cardiac Rhythm Management Division
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000010382
- Devices
- 1
- Registrations
- EUDAMED
- FDA recalls
- 148 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
AV Plus™ Ref 1368/58
Regimes: CE AIMDD Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000010382
- EUDAMED status
- Active
- EUDAMED registered name
- St. Jude Medical Cardiac Rhythm Management Division
- Registered address
- 15900, Valley View Ct., 91342, Sylmar, United States
- [email protected]
- PRRC contact
- Nalin Perera
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 1
- 2021 0
- 2022 8
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 17 Jun 2022 Z-1495-2022 Class II Ongoing There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Full distribution text
- 17 Jun 2022 Z-1496-2022 Class II Ongoing The Merlin" 2 PCS model MER3700 is a portable, dedicated programming
system designed to interrogate, program, display data from, and test Abbott
Medical implantable medical devices during implant and follow-up.
Full distribution text
- 17 Jun 2022 Z-1497-2022 Class II Ongoing The Merlin" 2 PCS model MER3700 is a portable, dedicated programming
system designed to interrogate, program, display data from, and test Abbott
Medical implantable medical devices during implant and follow-up.
Full distribution text
- 10 Mar 2022 Z-0964-2022 Class II Ongoing Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Full distribution text
- 10 Mar 2022 Z-0965-2022 Class II Ongoing Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Full distribution text
- 10 Mar 2022 Z-0988-2022 Class II Ongoing Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
- 10 Mar 2022 Z-0989-2022 Class II Ongoing Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
- 10 Mar 2022 Z-0990-2022 Class II Ongoing Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
- 17 Jun 2022 Z-1495-2022 Class II Ongoing There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
2020
- 22 Jan 2020 Z-1351-2020 Class II Terminated Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
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- 22 Jan 2020 Z-1351-2020 Class II Terminated Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
2018
- 13 Apr 2018 Z-0808-2020 Class II Terminated Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Full distribution text
- 13 Apr 2018 Z-0808-2020 Class II Terminated Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Show all 14 recalls
2015
- 3 Nov 2015 Z-0660-2016 Class I Terminated Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
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- 18 Aug 2015 Z-2784-2015 Class II Terminated Some devices exhibit backup VVI operation due to a backup reset.
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- 3 Nov 2015 Z-0660-2016 Class I Terminated Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
2014
- 18 Dec 2014 Z-0949-2015 Class II Terminated Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
Full distribution text
- 19 Aug 2014 Z-2572-2014 Class II Terminated An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.
Full distribution text
- 18 Dec 2014 Z-0949-2015 Class II Terminated Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
Frequently asked questions
How many devices does St. Jude Medical Cardiac Rhythm Management Division have in the registry?
The registry currently lists 1 device for St. Jude Medical Cardiac Rhythm Management Division. Devices recorded under merged duplicate company entries are counted once.
Which registries list St. Jude Medical Cardiac Rhythm Management Division's devices?
Among its 1 most recently registered device, St. Jude Medical Cardiac Rhythm Management Division has devices listed in EUDAMED (1 device).
What risk classes do St. Jude Medical Cardiac Rhythm Management Division's devices fall under?
Among its 1 most recently registered device, the classes recorded for St. Jude Medical Cardiac Rhythm Management Division's devices are active implantable (AIMDD). Each device page shows its own class and authorisation.
Are there FDA recall records for St. Jude Medical Cardiac Rhythm Management Division?
FDA recall records list 14 recalls initiated by St. Jude Medical Cardiac Rhythm Management Division, the most recent initiated on 17 Jun 2022. 8 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from St. Jude Medical Cardiac Rhythm Management Division in the registry?
The most recently registered devices listed for St. Jude Medical Cardiac Rhythm Management Division include AV Plus™.