Reported Jun 28, 2023 · Ongoing
CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; 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?
CRT-D DTBB2D1 VIVA S IS1/DF1 INTLModel Number DTBB2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720350
- Lot Serial Numbers
227 of 227 codes
BLS604430SBLS604248SBLS604229SBLS604258SBLS604234SBLS604223SBLS604309SBLS604224SBLS604227SBLS604222SBLS604308SBLS604256SBLS604257SBLS604310SBLS604313SBLS604245SBLS604253SBLS604252SBLS604239SBLS604226SBLS604371SBLS604380SBLS604417SBLS604419SBLS604432SBLS604560SBLS604562SBLS604366SBLS604368SBLS604375SBLS604376SBLS604169SBLS604170SBLS604360SBLS604365SBLS604369SBLS604372SBLS604379SBLS604525SBLS604554SBLS604572SBLS604363SBLS604171SBLS604361SBLS604377SBLS604378SBLS604418SBLS604428SBLS604434SBLS604556SBLS604561SBLS604567SBLS604571SBLS604563SBLS604362SBLS604364SBLS604370SBLS604373SBLS604422SBLS604523S
- Lot Serial Numbers
846 of 846 codes
BLS604445SBLS604613SBLS604737SBLS604754SBLS605210SBLS604596SBLS604658SBLS604689SBLS604721SBLS604726SBLS604730SBLS604750SBLS605135SBLS605194SBLS605200SBLS604846SBLS604866SBLS604919SBLS604930SBLS604950SBLS605180SBLS605187SBLS605199SBLS605211SBLS605216SBLS605217SBLS605220SBLS605263SBLS605285SBLS605367SBLS604835SBLS604869SBLS604882SBLS604999SBLS605198SBLS605322SBLS605368SBLS604446SBLS604448SBLS604436SBLS604447SBLS604449SBLS604441SBLS604438SBLS604451SBLS604474SBLS604650SBLS604662SBLS604663SBLS604768SBLS605430SBLS605431SBLS604657SBLS604659SBLS604656SBLS604708SBLS604739SBLS604766SBLS604806SBLS604815S
- Lot Serial Numbers
BLS605515SBLS605514SBLS605508SBLS605509SBLS605507S
- Amount recalled
- 1076 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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