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ABBOTT MEDICAL

United States·US-MF-000003851

Last updated September 17, 2026

Information

Country: United States
Address: 6901, Preston Road, Plano, United States
Website: abbott.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Chris Longpre
EUDAMED SRN: US-MF-000003851
FDA FEI Number: 3006705815
DUNS Number: —

Catalogue (246)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Armada™ 14 NC PTA Catheter	2300250-120	EUDAMED	Class IIa	Active
Armada™ 14 NC PTA Catheter	2300200-100	EUDAMED	Class IIa	Active
Armada™ 14 NC PTA Catheter	2310200-120	EUDAMED	Class IIa	Active
Armada™ 14 NC PTA Catheter	2310400-100	EUDAMED	Class IIa	Active
Armada™ 14 NC PTA Catheter	2310400-040	EUDAMED	Class IIa	Active
Armada™ 14 NC PTA Catheter	2310500-120	EUDAMED	Class IIa	Active
Armada™ 14 NC PTA Catheter	2300350-100	EUDAMED	Class IIa	Active
EnSite™ X EP System	K251234	FDA 510(k)	Class II	Active
TriClip Steerable Guide Catheter	K241538	FDA 510(k)	Class II	Active
EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)	K251463	FDA 510(k)	Class II	Active
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6	K232386	FDA 510(k)	Class II	Active
ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™	K251211	FDA 510(k)	Class II	Active
ILUMIEN System with AptiVue Software version D.3	K192267	FDA 510(k)	Class II	Active
Seguin Annuloplasty Ring	K253232	FDA 510(k)	Class II	Active
CentriMag™ Acute Circulatory Support System	K234118	FDA 510(k)	Class II	Active
EnSite X EP System	K213364	FDA 510(k)	Class II	Active
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled	K202066	FDA 510(k)	Class II	Active
Amplatzer Trevisio Intravascular Delivery System	K190581	FDA 510(k)	Class II	Active
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	K242841	FDA 510(k)	Class II	Active
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire	K240997	FDA 510(k)	Class II	Active
Aveir Introducer	K211989	FDA 510(k)	Class II	Active
IonicRF Generator	K201610	FDA 510(k)	Class II	Active
EnSite™ X EP System	K242016	FDA 510(k)	Class II	Active
Amplatzer Steerable Delivery Sheath	K220340	FDA 510(k)	Class II	Active
ViewFlex™ X ICE Catheter, Sensor Enabled™	K251231	FDA 510(k)	Class II	Active
ViewFlex™ Eco Reprocessed ICE Catheter	K231588	FDA 510(k)	Class II	Active
EnSite™ X EP System	K252013	FDA 510(k)	Class II	Active
Abbott Medical Grounding Pad, model RF-DGP-IS	K203293	FDA 510(k)	Class II	Active
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System	K201181	FDA 510(k)	Class II	Active
Disposable Radiofrequency Cannula	K253907	FDA 510(k)	Class II	Active
Advisor VL Circular Mapping Catheter, Sensor Enabled	K192037	FDA 510(k)	Class II	Active
Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)	K241370	FDA 510(k)	Class II	Active
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System	K210458	FDA 510(k)	Class II	Active
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire	K250552	FDA 510(k)	Class II	Active
MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)	K243224	FDA 510(k)	Class II	Active
MitraClip G4 Steerable Guide Catheter	K221397	FDA 510(k)	Class II	Active
JETi Hydrodynamic Thrombectomy System	K243549	FDA 510(k)	Class II	Active
Agilis NxT Steerable Introducer Dual-Reach	K243493	FDA 510(k)	Class II	Active
Amplatzer Steerable Delivery Sheath	K212026	FDA 510(k)	Class II	Active
Amplatzer Talisman Delivery Sheath	K212738	FDA 510(k)	Class II	Active
Amplatzer Guidewire	K250031	FDA 510(k)	Class II	Active
Assert-IQ (DM5100)	K253516	FDA 510(k)	Class II	Active
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)	K230283	FDA 510(k)	Class II	Active
EnSite™ X EP System	K231415	FDA 510(k)	Class II	Active
CPS Direct™ Universal slittable outer guide catheter (DS2C029)	K231311	FDA 510(k)	Class II	Active
ViewFlex Xtra Reprocessed ICE Catheter	K222217	FDA 510(k)	Class II	Active
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)	K252417	FDA 510(k)	Class II	Active
Armada™ 14 NC PTA Catheter	K252512	FDA 510(k)	Class II	Active
Aveir Retrieval Catheter	K213494	FDA 510(k)	Class II	Active
CPS AIM Universal II Slittable Inner Catheter	K221750	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (42)

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

Date	Recall No.	Class	Status	Reason
Oct 6, 2025	Z-0459-2026	—	open, classified	There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
Oct 6, 2025	Z-0458-2026	—	open, classified	There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
Feb 15, 2025	Z-1557-2025	—	open, classified	Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Nov 21, 2024	Z-0753-2025	—	open, classified	Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.
Oct 17, 2024	Z-0493-2025	—	open, classified	A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Oct 17, 2024	Z-0491-2025	—	open, classified	A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Oct 17, 2024	Z-0494-2025	—	open, classified	A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Oct 17, 2024	Z-0492-2025	—	open, classified	A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Oct 17, 2024	Z-0495-2025	—	open, classified	A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Oct 1, 2024	Z-0552-2025	—	open, classified	Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Oct 1, 2024	Z-0551-2025	—	open, classified	Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
May 22, 2024	Z-2431-2024	—	open, classified	Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
May 22, 2024	Z-2429-2024	—	open, classified	Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
May 22, 2024	Z-2432-2024	—	open, classified	Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
May 22, 2024	Z-2430-2024	—	open, classified	Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
May 16, 2024	Z-2358-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2360-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2362-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2363-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2364-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2368-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2359-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2369-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2365-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2265-2024	—	open, classified	Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
May 16, 2024	Z-2361-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2366-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
May 16, 2024	Z-2367-2024	—	open, classified	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Feb 5, 2024	Z-1695-2024	—	open, classified	Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Aug 16, 2023	Z-2614-2023	—	open, classified	Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Aug 16, 2023	Z-2615-2023	—	open, classified	Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Jul 18, 2023	Z-2508-2023	—	open, classified	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Jul 18, 2023	Z-2505-2023	—	open, classified	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Jul 18, 2023	Z-2510-2023	—	open, classified	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Jul 18, 2023	Z-2507-2023	—	open, classified	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Jul 18, 2023	Z-2509-2023	—	open, classified	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Jul 18, 2023	Z-2506-2023	—	open, classified	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Jul 18, 2023	Z-2511-2023	—	open, classified	Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Dec 9, 2019	Z-0789-2020	—	terminated	Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Dec 9, 2019	Z-0783-2020	—	terminated	Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Nov 11, 2019	Z-0720-2020	—	terminated	A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
Oct 14, 2019	Z-0664-2020	—	terminated	Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Abbott Medical Penang Pulau Pinang · MY FEI 3008377825