Reported Jun 28, 2023 · Ongoing
ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; 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 VISIA MRI AF S US/OUS DF4Model Number DVFC3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720817
- Lot Serial Numbers
2,714 of 2,714 codes
PMX613090SPMX610759SPMX613168SPMX604899SPMX606600SPMX605030SPMX605294SPMX605321SPMX605409SPMX605434SPMX605494SPMX605615SPMX605865SPMX605971SPMX606147SPMX606694SPMX606698SPMX606701SPMX606703SPMX606705SPMX606859SPMX607270SPMX608318SPMX611103SPMX613896SPMX613927SPMX613944SPMX612024SPMX613712SPMX613935SPMX613953SPMX611975SPMX613088SPMX613697SPMX613929SPMX613942SPMX607559SPMX611696SPMX611976SPMX611873SPMX607595SPMX611948SPMX607298SPMX611887SPMX612112SPMX607539SPMX607632SPMX611052SPMX612018SPMX612108SPMX613774SPMX613790SPMX607549SPMX607599SPMX612009SPMX612016SPMX612119SPMX613709SPMX613954SPMX609256S
- Amount recalled
- 16244 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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