Reported Jun 28, 2023 · Ongoing
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; 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 DTBB1D4 VIVA S IS1/DF4 USModel Number DTBB1D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720268
- Lot Serial Numbers
182 of 182 codes
BLN205385HBLN205423HBLN205617HBLN205500HBLN205517HBLN205644HBLN205573HBLN205101HBLN205395HBLN205424HBLN205448HBLN205505HBLN205574HBLN205579HBLN205432HBLN205460HBLN205545HBLN205566HBLN205554HBLN205583HBLN205390HBLN205669HBLN205438HBLN205653HBLN205533HBLN205387HBLN205527HBLN205528HBLN205571HBLN205591HBLN205623HBLN205485HBLN205501HBLN205594HBLN205618HBLN205381HBLN205462HBLN205684HBLN205479HBLN205509HBLN205627HBLN205663HBLN205682HBLN205382HBLN205384HBLN205549HBLN205557HBLN205482HBLN205454HBLN205548HBLN205560HBLN205408HBLN205521HBLN205529HBLN205552HBLN205491HBLN205645HBLN205586HBLN205480HBLN205516H
- Amount recalled
- 182 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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