Reported Jun 28, 2023 · Ongoing
ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; 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 VR MRI IS1 DF1Model Number DVPB3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178499
- Lot Serial Numbers
1,495 of 1,495 codes
RSE600116SRSE600346SRSE600428SRSE600572SRSE600505SRSE600512SRSE600513SRSE600515SRSE600517SRSE600518SRSE600519SRSE600520SRSE601603SRSE601609SRSE601846SRSE601849SRSE601856SRSE601872SRSE601873SRSE602612SRSE600806SRSE601469SRSE600412SRSE600554SRSE602156SRSE602245SRSE602658SRSE601353SRSE600764SRSE602060SRSE600993SRSE602062SRSE602445SRSE600734SRSE601371SRSE602291SRSE602297SRSE600746SRSE601898SRSE602099SRSE600431SRSE600674SRSE601618SRSE601619SRSE601620SRSE601621SRSE601622SRSE600190SRSE600193SRSE601209SRSE601330SRSE601355SRSE601504SRSE600672SRSE602161SRSE601259SRSE602483SRSE602484SRSE600831SRSE601521S
- Lot Serial Numbers
436 of 436 codes
RSE602015SRSE602378SRSE602000SRSE602001SRSE602497SRSE602701SRSE602709SRSE603162SRSE602421SRSE602456SRSE602530SRSE602414SRSE602691SRSE603007SRSE602980SRSE602520SRSE602532SRSE602395SRSE602396SRSE602997SRSE602998SRSE600053SRSE600086SRSE601215SRSE601346SRSE602728SRSE602682SRSE600019SRSE602834SRSE602398SRSE601289SRSE602003SRSE602218SRSE600042SRSE600079SRSE600874SRSE601210SRSE601433SRSE601472SRSE601815SRSE602045SRSE602330SRSE601247SRSE602027SRSE601440SRSE601861SRSE602304SRSE602837SRSE602731SRSE601304SRSE601408SRSE601998SRSE602327SRSE602403SRSE601013SRSE601244SRSE602032SRSE601189SRSE600075SRSE601181S
- Amount recalled
- 1930 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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