Reported Jun 28, 2023 · Ongoing
ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; 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 DVAB1D4 VISIA AF US DF4Model Number DVAB1D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720626
- Lot Serial Numbers
240 of 240 codes
BWP202537HBWP202379HBWP202439HBWP202454HBWP202474HBWP202510HBWP202522HBWP202523HBWP202252HBWP202639HBWP202514HBWP202179HBWP202398HBWP202399HBWP202554HBWP202420HBWP202447HBWP202494HBWP201863HBWP202260HBWP202324HBWP202359HBWP202432HBWP202542HBWP202643HBWP202292HBWP202297HBWP202365HBWP202366HBWP202369HBWP202549HBWP202578HBWP202213HBWP202287HBWP202471HBWP202583HBWP201864HBWP202626HBWP202358HBWP202331HBWP202306HBWP202385HBWP202272HBWP202404HBWP202434HBWP202453HBWP202553HBWP202576HBWP202586HBWP202588HBWP202598HBWP202544HBWP202159HBWP202161HBWP202162HBWP202163HBWP202164HBWP202165HBWP202561HBWP202563H
- Amount recalled
- 240 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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