Reported Jun 28, 2023 · Ongoing
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; 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 DDMD3D4 PRIMO MRIModel Number DDMD3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000001506
- Lot Serial Numbers
2,714 of 2,714 codes
CWN606940SCWN606941SCWN606806SCWN609866SCWN607173SCWN607174SCWN606850SCWN605016SCWN605224SCWN605226SCWN602473SCWN605696SCWN606066SCWN601517SCWN610794SCWN611698SCWN611709SCWN611042SCWN611699SCWN608530SCWN611057SCWN611194SCWN611137SCWN611173SCWN611168SCWN610989SCWN610994SCWN610999SCWN608676SCWN610063SCWN608932SCWN609322SCWN610602SCWN608143SCWN610351SCWN611528SCWN611651SCWN607995SCWN611583SCWN608694SCWN611439SCWN611468SCWN611541SCWN611395SCWN608844SCWN611563SCWN611417SCWN608827SCWN608184SCWN608185SCWN607983SCWN609341SCWN612034SCWN610308SCWN609462SCWN608691SCWN611586SCWN611558SCWN611650SCWN611477S
- Amount recalled
- 11,239 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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