Reported Jun 28, 2023 · Ongoing
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; 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 DVFB1D4 VISIA MRI AF US DF4Model Number DVFB1D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720794
- Lot Serial Numbers
2,714 of 2,714 codes
PKX219646HPKX220040HPKX220056HPKX221681HPKX222407HPKX222934HPKX223422HPKX225541HPKX228394HPKX228784HPKX228814HPKX230405HPKX231486HPKX232877HPKX233043HPKX236253HPKX238847HPKX238969HPKX224741HPKX224742HPKX226542HPKX230306HPKX231799HPKX231802HPKX234882HPKX234889HPKX236705HPKX236715HPKX239415HPKX240693HPKX234754HPKX237931HPKX221151HPKX222802HPKX224257HPKX227009HPKX227059HPKX227453HPKX229189HPKX231976HPKX232346HPKX233404HPKX235182HPKX236627HPKX240315HPKX219199HPKX221009HPKX221252HPKX221253HPKX221256HPKX221257HPKX221262HPKX221264HPKX221271HPKX221272HPKX221273HPKX221276HPKX224585HPKX224586HPKX224589H
- Amount recalled
- 34350 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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