Reported Jun 28, 2023 · Ongoing
CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; 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 DTBA1D1 VIVA XT IS1/DF1 USModel Number DTBA1D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720312
- Lot Serial Numbers
1,006 of 1,006 codes
BLF258142HBLF257918HBLF258186HBLF258209HBLF257508HBLF258084HBLF257081HBLF257089HBLF257260HBLF257290HBLF257410HBLF257440HBLF257565HBLF257668HBLF257684HBLF257873HBLF257966HBLF256897HBLF257648HBLF256756HBLF256776HBLF256865HBLF257835HBLF257086HBLF257198HBLF257413HBLF257605HBLF257611HBLF257863HBLF257960HBLF257342HBLF257460HBLF257657HBLF256948HBLF257877HBLF256848HBLF257404HBLF257931HBLF257961HBLF258043HBLF258080HBLF257904HBLF257104HBLF257029HBLF257408HBLF257431HBLF257388HBLF257618HBLF257916HBLF257972HBLF256843HBLF256844HBLF256971HBLF257125HBLF257347HBLF258090HBLF257677HBLF258051HBLF257844HBLF257627H
- Lot Serial Numbers
468 of 468 codes
BLF600587SBLF600701SBLF600748SBLF600569SBLF600439SBLF600140SBLF600562SBLF600468SBLF600176SBLF600313SBLF600811SBLF600555SBLF600533SBLF600535SBLF600266SBLF600722SBLF600277SBLF600623SBLF600227SBLF600574SBLF600680SBLF600240SBLF600259SBLF600263SBLF600349SBLF600508SBLF600528SBLF600847SBLF600171SBLF600092SBLF600405SBLF600321SBLF600145SBLF600049SBLF600322SBLF600456SBLF600411SBLF600124SBLF600486SBLF600341SBLF600391SBLF600532SBLF600230SBLF600130SBLF600487SBLF600505SBLF600856SBLF600730SBLF600422SBLF600446SBLF600785SBLF600149SBLF600242SBLF600615SBLF600243SBLF600015SBLF600632SBLF600032SBLF600137SBLF600198S
- Amount recalled
- 1473 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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