Reported Jun 28, 2023 · Ongoing
ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; 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 XT VR MRI DF4Model Number DVPA2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178468
- Lot Serial numbers
2,714 of 2,714 codes
RSD605765SRSD605767SRSD607880SRSD607881SRSD607886SRSD607890SRSD603551SRSD603552SRSD603553SRSD603554SRSD603555SRSD600536SRSD601541SRSD602283SRSD602524SRSD602542SRSD602924SRSD603303SRSD603396SRSD607136SRSD608177SRSD608547SRSD606272SRSD607000SRSD607711SRSD607712SRSD602036SRSD602645SRSD602659SRSD603096SRSD603670SRSD604815SRSD608193SRSD605918SRSD605919SRSD605920SRSD605921SRSD605922SRSD605923SRSD605924SRSD605926SRSD605927SRSD605929SRSD605930SRSD605931SRSD605932SRSD605933SRSD604238SRSD604294SRSD604312SRSD604313SRSD604314SRSD604614SRSD604616SRSD604710SRSD604721SRSD604725SRSD605925SRSD607788SRSD607789S
- Amount recalled
- 9325 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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