Reported Jun 28, 2023 · Ongoing
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; 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 COBALT DR MRI IS1 DF1Model Number DDPB3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178376
- Lot Serial Numbers
1,658 of 1,658 codes
RSN600341SRSN601060SRSN601316SRSN601817SRSN602193SRSN600668SRSN600669SRSN600670SRSN600672SRSN601804SRSN601808SRSN601810SRSN602514SRSN601050SRSN601241SRSN602551SRSN600820SRSN603061SRSN601870SRSN602495SRSN601384SRSN601691SRSN601237SRSN602951SRSN603065SRSN600626SRSN600877SRSN601019SRSN601020SRSN601022SRSN601027SRSN601028SRSN601029SRSN601030SRSN601032SRSN601038SRSN601040SRSN600997SRSN601013SRSN601039SRSN600837SRSN601913SRSN601957SRSN600334SRSN600116SRSN602781SRSN602004SRSN602073SRSN601983SRSN600628SRSN601374SRSN600624SRSN601004SRSN601902SRSN602210SRSN600402SRSN600359SRSN600360SRSN600361SRSN600366S
- Lot Serial Numbers
284 of 284 codes
RSN602082SRSN602851SRSN602638SRSN602740SRSN602741SRSN602742SRSN603203SRSN603040SRSN602779SRSN602626SRSN602814SRSN603128SRSN603046SRSN601857SRSN602603SRSN603181SRSN603213SRSN601756SRSN602597SRSN600256SRSN601222SRSN601809SRSN601774SRSN601805SRSN602623SRSN602644SRSN600263SRSN601410SRSN601713SRSN602089SRSN602672SRSN602743SRSN602922SRSN603126SRSN600073SRSN600082SRSN600275SRSN600326SRSN602075SRSN602775SRSN603173SRSN601853SRSN602099SRSN602815SRSN603115SRSN601729SRSN600085SRSN600260SRSN601781SRSN602621SRSN603158SRSN601793SRSN601824SRSN601836SRSN601714SRSN603155SRSN602620SRSN602818SRSN602981SRSN603174S
- Amount recalled
- 1941 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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