Abbott

2015 incl. Thoratec (USA), 2017 incl. St. Jude Medical (USA)reg.: n/a
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IMPLANTS

U.S.A.

product groupcardiovascular system
coronary intervention
productsAbsorb (bioresorbable)
coronary stentsMULTI-LINK 8 Coronary Stent System
JOSTENT GRAFTMASTER Coronary Stent Graft System
drug eluting systemsXIENCE Alpine Everolimus Eluting Coronary Stent System
XIENCE Xpedition Everolimus Eluting Coronary Stent
 valvesCOPILOT Bleedback Control Valv
Emboshield NAV6 Embolic Protection System
MitraClip Transcatheter Mitral Valve Repair System

product groupcardiovascular system
heart failure
productsHeartMate 3TM LVAD
HeartMate II™ LVAD

product groupcardiovascular system,
peripheral Intervention
productsPeripheral & Biliary Self-Expanding Stent SystemsSupera Peripheral Stent System
Xact Carotid Stent System
Peripheral Balloon Expandable Stent SystemsOmnilink Elite Vascular Balloon-Expandable Stent System
Peripheral Dilatation Catheters
Peripheral Drug Eluting Stents
carotid interventionEmboshield NAV6 Embolic Protection System
vessel closure

product groupcardiac rhythm management
pacemaker
productsAssurity MRI™ pacemaker
Confirm Rx™ insertable cardiac monitor (ICM)
Endurity™ pacemaker
Quadra Allure MP™ CRT-P
Quadra Assura MP™ CRT-D
discontinuedAccent™
Accent MRI™
Accent ST™
Anthem™
Fortify™
Fortify Assura™
Nanostim™
Quadra Assura™
Unify™
Unify Assura™
Unify Quadra™
Unify Quadra™

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……….

 

product groupnervous system
productsdeep brain stimulation
spinal chord stimulation SCSProclaim Elite™ Recharge-free SCS System
dorsal root ganglion therapyProclaim™ DRG Neurostimulator System
Axium™ Neurostimulator System

direction(s)
n/a
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