Abbott (Vascular Devices)

U.S.A. reg.: n/a
 (2015 incl. Thoratec (U.S.A.), 2017 incl. St. Jude Medical, U.S.A.)

product group heart / vessel
products coronary intervention Absorb (bioresorbable)
 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 Xpedition Everolimus Eluting Coronary Stent
 valves COPILOT Bleedback Control Valv
Emboshield NAV6 Embolic Protection System
MitraClip Transcatheter Mitral Valve Repair System

product group heart / vessel
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 heart electro stimulation, pacemaker (ICD, CRT-D Devices)
products Accent™
Accent MRI™
Accent ST™
Fortify Assura™
Quadra Assura™
Quadra Assura MP™
Unify Assura™
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 group head / brain / nerves
products deep brain stimulation
spinal chord stimulation