Reported Jun 28, 2023 · Ongoing
ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; 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-DR DDMB1D1 EVERA MRI XT US DF1Model Number DDMB1D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837713
- Lot Serial Numbers
2,714 of 2,714 codes
CWA218162HCWA219897HCWA221224HCWA222730HCWA223319HCWA224001HCWA230660HCWA212204HCWA215507HCWA219655HCWA228049HCWA228101HCWA230635HCWA230642HCWA213967HCWA217145HCWA220168HCWA225093HCWA229346HCWA232234HCWA215257HCWA215420HCWA221756HCWA221922HCWA222159HCWA225001HCWA225149HCWA225777HCWA227620HCWA227845HCWA228935HCWA229962HCWA231576HCWA231578HCWA213741HCWA216957HCWA223516HCWA225894HCWA231485HCWA211463HCWA211464HCWA211465HCWA211466HCWA211467HCWA211468HCWA211470HCWA214199HCWA214200HCWA214201HCWA214203HCWA214205HCWA214208HCWA214210HCWA214211HCWA214212HCWA214213HCWA217480HCWA217481HCWA217482HCWA217483H
- Amount recalled
- 22484 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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