Reported Jun 28, 2023 · Ongoing
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; 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-VR DVFB1D1 VISIA AF MRI US DF1Model Number DVFB1D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837799
- Lot Serial Numbers
2,714 of 2,714 codes
CWG208686HCWG211264HCWG205930HCWG208117HCWG210956HCWG210958HCWG211814HCWG212178HCWG208135HCWG209489HCWG209599HCWG212702HCWG214349HCWG214379HCWG206584HCWG208347HCWG206776HCWG206895HCWG211478HCWG211709HCWG212079HCWG212183HCWG212836HCWG205283HCWG205284HCWG205288HCWG207805HCWG207808HCWG207809HCWG207810HCWG207811HCWG207812HCWG208949HCWG209030HCWG209031HCWG209285HCWG209646HCWG209659HCWG209823HCWG210928HCWG210929HCWG211866HCWG212840HCWG212841HCWG212842HCWG212843HCWG212844HCWG212846HCWG212847HCWG212851HCWG212853HCWG212854HCWG213620HCWG213622HCWG213623HCWG206242HCWG206868HCWG209799HCWG212914HCWG205298H
- Amount recalled
- 12099 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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