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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 5 of 5

Device	Model / Reference	Registries	Class	Status
Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80	K260499	FDA 510(k)	Class II	Active
EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License	K223094	FDA 510(k)	Class II	Active
Amulet™ Steerable Delivery Sheath	K232690	FDA 510(k)	Class II	Active
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License	K201148	FDA 510(k)	Class II	Active
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1	K192019	FDA 510(k)	Class II	Active
ViewFlex™ Eco Reprocessed ICE Catheter	K230934	FDA 510(k)	Class II	Active
Amulet™ Steerable Delivery Sheath	K250426	FDA 510(k)	Class II	Active
Ultiri Measurement System	K220243	FDA 510(k)	Class II	Active
EnSite™ X EP System	K260212	FDA 510(k)	Class II	Active
Assert-IQ™ Insertable Cardiac Monitor	K230286	FDA 510(k)	Class II	Active
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)	K253459	FDA 510(k)	Class II	Active
JETi™Hydrodynamic Thrombectomy System	K232458	FDA 510(k)	Class II	Active
Dragonfly OpStar™ Imaging Catheter	K230411	FDA 510(k)	Class II	Active
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™	K241372	FDA 510(k)	Class II	Active
Tendyne™ Transcatheter Mitral Valve System	P240042	FDA PMA	Class III	Active
TriClip™ G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW)	P230007	FDA PMA	Class III	Active
Volt™ PFA System	P250022	FDA PMA	Class III	Active
Navitor Transcatheter Aortic Valve Implantation System	P190023	FDA PMA	Class III	Active
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System	P230036	FDA PMA	Class III	Active
Amplatzer™ Amulet™ Left Atrial Appendage Occluder	P200049	FDA PMA	Class III	Active
Microny Pacemakers	P970013	FDA PMA	Class III	Active
FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE)	P110016	FDA PMA	Class III	Active
TactiFlex Ablation Catheter, Sensor Enabled	P220013	FDA PMA	Class III	Active
Aveir VR Delivery Catheter LSCD111; Aveir DR Delivery Catheter LSCD201	P150035	FDA PMA	Class III	Active
Amplatzer Muscular VSD Occluder	P040040	FDA PMA	Class III	Active
Epic Valve	P040021	FDA PMA	Class III	Active
HeartMate II™ Left Ventricular Assist System	P060040	FDA PMA	Class III	Active
Amplatzer Duct Occluder	P020024	FDA PMA	Class III	Active
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps	P030035	FDA PMA	Class III	Active
Bileaflet-Center Opening Cardiac Valve	P810002	FDA PMA	Class III	Active
HeartMate 3™ Left Ventricular Assist System	P160054	FDA PMA	Class III	Active
Amplatzer Septal Occluder & Multi-Fenestrated Septal Occluder Cribriform	P000039	FDA PMA	Class III	Active
Spinal Cord Stimulation Leads, Deep Brain Stimulation Leads, Adaptors, And Extensions	P140009	FDA PMA	Class III	Active
Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT)	P100029	FDA PMA	Class III	Active
Durata/Riata St Optim/Riata St Family Of Leads	P950022	FDA PMA	Class III	Active
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)	P150004	FDA PMA	Class III	Active
AMPLATZER PFO Occluder	P120021	FDA PMA	Class III	Active
Tendril 1888 Lead	P960013	FDA PMA	Class III	Active
Genesis And Eon Family Spinal Cord Stimulation (scs) System	P010032	FDA PMA	Class III	Active
The Tendril MRI lead	P140033	FDA PMA	Class III	Active
St Jude Medical Merlin 3650 Programmer	P030054	FDA PMA	Class III	Active
Afp Cardiac Pacing System, Sensolog Cardiac Pacing System, And Synchrony Cardiac Pacing System	P880086	FDA PMA	Class III	Active
MitraClip™ G4 Clip Delivery System	P100009	FDA PMA	Class III	Active
Passive Plus Dx Endocardial Steroid Eluting, Passive-Fixation Pacing Leads	P960030	FDA PMA	Class III	Active
CardioMEMS HF System	P100045	FDA PMA	Class III	Active
Tendril STS 2088TC Lead	P910023	FDA PMA	Class III	Active

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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