Reported Jun 28, 2023 · Ongoing
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; 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 DTBA1D4 VIVA XT IS1/DF4 USModel Number DTBA1D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720251
- Lot Serial Numbers
424 of 424 codes
BLE221424HBLE221443HBLE221244HBLE221357HBLE221415HBLE221487HBLE221190HBLE221267HBLE221842HBLE221265HBLE221430HBLE221711HBLE221346HBLE221631HBLE221285HBLE221405HBLE221436HBLE221551HBLE221411HBLE221342HBLE221584HBLE221694HBLE221282HBLE221465HBLE221191HBLE221384HBLE221805HBLE221309HBLE221222HBLE221327HBLE221548HBLE221562HBLE221702HBLE221450HBLE221715HBLE221246HBLE221654HBLE221686HBLE221713HBLE221750HBLE221758HBLE221814HBLE221828HBLE221843HBLE221844HBLE221851HBLE221854HBLE221855HBLE221861HBLE221561HBLE221727HBLE221751HBLE221789HBLE221862HBLE221670HBLE221707HBLE221752HBLE221849HBLE221475HBLE221687H
- Lot Serial Numbers
238 of 238 codes
BLE600173SBLE600088SBLE600188SBLE600352SBLE600131SBLE600302SBLE600008SBLE600063SBLE600238SBLE600207SBLE600168SBLE600107SBLE600180SBLE600114SBLE600111SBLE600264SBLE600313SBLE600360SBLE600233SBLE600003SBLE600191SBLE600016SBLE600234SBLE600059SBLE600069SBLE600027SBLE600071SBLE600105SBLE600319SBLE600139SBLE600046SBLE600345SBLE600006SBLE600252SBLE600310SBLE600151SBLE600143SBLE600109SBLE600297SBLE600199SBLE600200SBLE600393SBLE600394SBLE600395SBLE600396SBLE600397SBLE600350SBLE600011SBLE600186SBLE600096SBLE600037SBLE600092SBLE600062SBLE600202SBLE600254SBLE600323SBLE600240SBLE600181SBLE600288SBLE600311S
- Amount recalled
- 661 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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