Reported Jun 28, 2023 · Ongoing
ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; 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 DDMB2D1 EVERA MRI XT OUS DF1Model Number DDMB2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837720
- Lot Serial Numbers
2,714 of 2,714 codes
CWB609778SCWB609784SCWB609523SCWB603432SCWB605718SCWB601752SCWB601945SCWB601946SCWB602803SCWB605225SCWB607387SCWB609714SCWB605552SCWB601729SCWB602371SCWB603105SCWB603660SCWB603852SCWB604726SCWB605271SCWB608325SCWB609120SCWB607821SCWB607823SCWB607829SCWB607834SCWB607881SCWB607884SCWB607885SCWB607886SCWB608671SCWB608672SCWB608675SCWB608676SCWB608677SCWB608678SCWB608680SCWB608681SCWB608683SCWB608684SCWB608686SCWB608687SCWB608690SCWB608691SCWB608692SCWB608697SCWB609222SCWB609930SCWB609931SCWB607959SCWB608041SCWB608051SCWB608052SCWB608055SCWB608064SCWB608067SCWB608068SCWB608069SCWB608073SCWB608074S
- Amount recalled
- 8626 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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