Reported Jun 28, 2023 · Ongoing
ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; 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 DVBB2D1 EVERA XT IS1/DF1 INTLModel Number DVBB2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169218017
- Lot Serial numbers
119 of 119 codes
BWK607537SBWK607358SBWK607401SBWK607460SBWK607496SBWK607540SBWK607351SBWK607371SBWK607254SBWK607394SBWK607446SBWK607457SBWK607473SBWK607498SBWK607503SBWK607536SBWK607381SBWK607393SBWK607369SBWK607474SBWK607432SBWK607439SBWK607523SBWK607448SBWK607526SBWK607383SBWK607434SBWK607463SBWK607360SBWK607437SBWK607472SBWK607451SBWK607449SBWK607436SBWK607527SBWK607361SBWK607275SBWK607326SBWK607343SBWK607384SBWK607391SBWK607479SBWK607501SBWK607507SBWK607508SBWK607518SBWK607520SBWK607535SBWK607544SBWK607327SBWK607379SBWK607521SBWK607382SBWK607502SBWK607366SBWK607386SBWK607441SBWK607468SBWK607497SBWK607465S
- Lot Serial Numbers
363 of 363 codes
BWK607337SBWK607219SBWK607243SBWK607277SBWK607150SBWK607222SBWK607270SBWK607276SBWK607282SBWK607285SBWK607288SBWK607289SBWK607295SBWK607330SBWK607478SBWK607480SBWK607481SBWK607482SBWK607483SBWK607486SBWK607203SBWK607205SBWK607234SBWK607396SBWK607856SBWK607600SBWK607613SBWK607731SBWK607488SBWK607490SBWK607493SBWK607733SBWK607296SBWK607217SBWK607402SBWK607404SBWK607405SBWK607484SBWK607605SBWK607737SBWK607751SBWK607214SBWK607218SBWK607292SBWK607322SBWK607334SBWK607336SBWK607216SBWK607244SBWK607250SBWK607279SBWK607220SBWK607300SBWK607420SBWK607422SBWK607430SBWK607431SBWK607476SBWK607477SBWK607299S
- Lot Serial Numbers
874 of 874 codes
BWK608397SBWK608751SBWK607995SBWK608734SBWK608735SBWK608737SBWK607960SBWK608606SBWK607805SBWK607680SBWK608205SBWK607625SBWK607656SBWK607624SBWK607694SBWK607790SBWK607797SBWK607812SBWK608194SBWK608226SBWK608143SBWK607574SBWK608175SBWK607646SBWK607659SBWK607660SBWK607686SBWK607696SBWK607697SBWK607699SBWK607701SBWK607708SBWK607800SBWK607801SBWK607806SBWK607808SBWK607809SBWK607811SBWK607814SBWK607816SBWK607817SBWK607822SBWK607823SBWK607824SBWK607825SBWK607850SBWK607854SBWK607875SBWK607945SBWK608035SBWK608037SBWK608141SBWK608142SBWK608220SBWK608223SBWK608224SBWK608229SBWK608278SBWK608292SBWK608335S
- Amount recalled
- 1354 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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