Reported Jun 28, 2023 · Ongoing
ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; 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 DF4Model Number DDPB3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178390
- Lot Serial Numbers
2,714 of 2,714 codes
RSO600207SRSO600934SRSO602587SRSO602860SRSO603892SRSO600679SRSO612257SRSO602636SRSO604992SRSO609567SRSO609647SRSO609795SRSO609900SRSO610931SRSO607136SRSO609278SRSO601095SRSO601096SRSO601098SRSO601472SRSO601473SRSO601474SRSO601475SRSO601476SRSO601477SRSO601478SRSO601479SRSO604357SRSO604358SRSO605928SRSO606135SRSO606155SRSO603632SRSO603681SRSO607412SRSO607605SRSO610650SRSO600968SRSO601258SRSO603258SRSO603300SRSO603339SRSO603742SRSO603773SRSO612385SRSO601910SRSO601911SRSO601913SRSO602604SRSO602611SRSO603824SRSO603826SRSO603876SRSO609857SRSO610204SRSO609865SRSO610317SRSO601050SRSO601392SRSO601568S
- Amount recalled
- 11,645 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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