Reported Jun 28, 2023 · Ongoing
ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; 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 XT OUS IS1/DF1Model Number DVAB2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720756
- Lot Serial Numbers
71 of 71 codes
BWR600821SBWR600947SBWR600936SBWR600937SBWR600941SBWR600946SBWR600959SBWR601046SBWR600938SBWR601096SBWR601093SBWR600979SBWR601092SBWR600997SBWR600934SBWR600965SBWR601050SBWR601049SBWR600823SBWR601053SBWR600983SBWR600989SBWR600984SBWR601055SBWR601057SBWR601098SBWR600822SBWR600980SBWR600981SBWR600982SBWR601097SBWR601100SBWR601095SBWR601101SBWR600991SBWR601051SBWR601058SBWR601099SBWR601094SGTIN BWR601149SBWR601155SBWR601137SBWR601138SBWR601108SBWR601113SBWR601111SBWR601119SBWR601144SBWR601146SBWR601147SBWR601148SBWR601067SBWR601150SBWR601152SBWR601115SBWR601105SBWR601112SBWR601059SBWR601061SBWR601062S
- Amount recalled
- 71 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.
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