Reported Jun 28, 2023 · Ongoing
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; 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 DDMD3D1 PRIMO MRIModel Number DDMD3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000001483
- Lot Serial Numbers
2,714 of 2,714 codes
CWM603134SCWM600439SCWM601269SCWM603840SCWM603922SCWM601037SCWM602990SCWM603292SCWM602888SCWM602567SCWM604350SCWM604400SCWM604147SCWM604447SCWM603919SCWM604293SCWM603993SCWM604453SCWM604276SCWM603779SCWM603512SCWM604434SCWM604110SCWM603974SCWM604303SCWM604451SCWM604296SCWM603643SCWM604349SCWM603935SCWM603697SCWM603897SCWM604404SCWM603551SCWM601796SCWM601798SCWM601800SCWM601801SCWM601802SCWM601905SCWM601911SCWM601931SCWM602000SCWM602003SCWM602004SCWM602005SCWM602006SCWM602097SCWM602098SCWM602124SCWM602139SCWM602709SCWM602710SCWM602711SCWM602823SCWM602836SCWM602838SCWM602847SCWM602848SCWM602883S
- Amount recalled
- 3801 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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