Reported Jun 28, 2023 · Ongoing
ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; 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 DVFC3D1 VISIA AF MRI S OUS/US DF1Model Number DVFC3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837812
- Lot Serial numbers
2,714 of 2,714 codes
CWJ604194SCWJ604707SCWJ604057SCWJ602128SCWJ604288SCWJ602870SCWJ601914SCWJ603587SCWJ603802SCWJ601000SCWJ601001SCWJ601158SCWJ601706SCWJ601799SCWJ601845SCWJ604343SCWJ604387SCWJ601910SCWJ603379SCWJ603449SCWJ603454SCWJ603109SCWJ603385SCWJ603717SCWJ604036SCWJ604043SCWJ604092SCWJ604118SCWJ604397SCWJ603165SCWJ603501SCWJ603684SCWJ603685SCWJ603693SCWJ603831SCWJ604218SCWJ604314SCWJ604338SCWJ601875SCWJ601903SCWJ603686SCWJ603836SCWJ603869SCWJ603875SCWJ604377SCWJ601894SCWJ601905SCWJ601909SCWJ603429SCWJ603660SCWJ603060SCWJ603731SCWJ603760SCWJ604336SCWJ604355SCWJ603859SCWJ603697SCWJ603700SCWJ603849SCWJ604337S
- Amount recalled
- 5622 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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