Abbott

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

unregistered register now update records

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

product group	data implants, chips (transmitting)
products	FreeStyle Libre	( CGM )
	FreeStyle Libre 2	( CGM )
	FreeStyle Libre 3	( CGM )
	FreeStyle Libre for Kids	( CGM )
	FreeStyle Libre 14 day	( CGM )

direction(s)
	n/a
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