Abbott

2015 incl. Thoratec (USA), 2017 incl. St. Jude Medical (USA) unregistered
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IMPLANTS

U.S.A.
product group cardiovascular system
coronary intervention
products coronary stents MULTI-LINK 8 Coronary Stent System
JOSTENT GRAFTMASTER Coronary Stent Graft System
drug eluting systems XIENCE Alpine Everolimus Eluting Coronary Stent System XIENCE Skypoint™
XIENCE Xpedition Everolimus Eluting Coronary Stent XIENCE Sierra™
 occluder Amplatzer Amulet Left Atrial Appendage Occluder Amplatzer™ Duct Occluder

Amplatzer™ Duct Occluder II

Amplatzer Piccolo™ Occluder

COPILOT Bleedback Control Valv
Emboshield NAV6 Embolic Protection System
valves MitraClip Transcatheter Mitral Valve Repair System
Portico Transcatheter Aortic Valve Implantation System
discontinued Absorb stent (bioresorbable) Absorb (bioresorbable)
product group cardiovascular system
heart failure
products HeartMate 3TM LVAD
HeartMate II™ LVAD
product group cardiovascular system
peripheral intervention
products Peripheral & Biliary Self-Expanding Stent Systems Supera Peripheral Stent System
Xact Carotid Stent System
Peripheral Balloon Expandable Stent Systems Omnilink Elite Vascular Balloon-Expandable Stent System
Peripheral Dilatation Catheters
Peripheral Drug Eluting Stents
carotid intervention Emboshield NAV6 Embolic Protection System
vessel closure
product group cardiac rhythm management
pacemaker
products Assurity MRI™ pacemaker WARNING recall of a subset of pacemakers from 04-2015 to 02-2019
Aveir VR Leadless pacemaker
Confirm Rx™ insertable cardiac monitor (ICM)
Endurity™ pacemaker WARNING recall of a subset of pacemakers from 04-2015 to 02-2019
Quadra Allure MP™ CRT-P
Quadra Assura MP™ CRT-D
discontinued Accent™
Accent MRI™
Accent ST™
Anthem™
Fortify™
Fortify Assura™
Nanostim™
Quadra Assura™
Unify™
Unify Assura™
Unify Quadra™
Zenex

In October 2016 it was notified that a subset of these ICDs and cardiac resynchronization therapy defibrillators (CRT-D) manufactured between January 2010 and May 2015 could potentially experience premature battery depletion. On August 29, 2017 we released a new Battery Performance Alert. More information……….

On August 23, 2017, the FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action,  to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers. The firmware update will be available beginning August 29, 2017. Pacemakers manufactured beginning August 28, 2017 will have this update pre-loaded in the device and will not need the update. More information……….

March 15, 2021: Abbott recalls Assurity™ and Endurity™ Pacemakers distributed April 29 2015 to February 20 2019, for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life. Published March 15, 2021. More information…..

product group nervous system
products deep brain stimulation DBS Infinity™ DBS System (Parkinson)
spinal chord stimulation SCS Proclaim Elite™ Recharge-free SCS System
dorsal root ganglion therapy Axium™ Neurostimulator System
Proclaim™ DRG Neurostimulator System
direction(s)
n/a
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