Reported Jun 28, 2023 · Ongoing
ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
ICD-VR VISIA AF S US/OUS DF4Model Number DVAC3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720787
- Lot Serial Numbers
150 of 150 codes
BWV600051SBWV600052SBWV600078SBWV600079SBWV600010SBWV600094SBWV600024SBWV600027SBWV600031SBWV600032SBWV600041SBWV600042SBWV600043SBWV600044SBWV600045SBWV600046SBWV600047SBWV600068SBWV600069SBWV600070SBWV600071SBWV600072SBWV600073SBWV600074SBWV600087SBWV600088SBWV600089SBWV600090SBWV600099SBWV600101SBWV600105SBWV600107SBWV600108SBWV600109SBWV600110SBWV600111SBWV600112SBWV600113SBWV600114SBWV600115SBWV600155SBWV600157SBWV600160SBWV600161SBWV600162SBWV600163SBWV600164SBWV600165SBWV600166SBWV600167SBWV600168SBWV600170SBWV600171SBWV600172SBWV600173SBWV600174SBWV600175SBWV600176SBWV600177SBWV600178S
- Lot Serial Numbers
BWV600261SBWV600263SBWV600265SBWV600267SBWV600258SBWV600259SBWV600284SBWV600285SBWV600286SBWV600287SBWV600288SBWV600289SBWV600290SBWV600291SBWV600292SBWV600293SBWV600294SBWV600295SBWV600296SBWV600297SBWV600298SBWV600300SBWV600301SBWV600302SBWV600303SBWV600304SBWV600305SBWV600306SBWV600307SBWV600308SBWV600309SBWV600310SBWV600311SBWV600312SBWV600313SBWV600314SBWV600315SBWV600316SBWV600317SBWV600318SBWV600320SBWV600266SBWV600260SBWV600262SBWV600264S
- Amount recalled
- 194 units
This recall covers 120 products
The agency filed one notice per product. You are reading one of them; the other 119 are below.
107 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.