Reported Jun 28, 2023 · Ongoing
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; 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 AF S US/OUS IS1/DF1Model Number DVAC3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720770
- Lot Serial numbers
69 of 69 codes
BWU600672SBWU600685SBWU600654SBWU600656SBWU600555SBWU600638SBWU600641SBWU600642SBWU600647SBWU600648SBWU600650SBWU600651SBWU600664SBWU600643SBWU600645SBWU600557SBWU600556SBWU600763SBWU600640SBWU600639SBWU600649SBWU600661SBWU600662SBWU600663SBWU600665SBWU600666SBWU600671SBWU600673SBWU600676SBWU600646SBWU600652SBWU600653SBWU600655SBWU600658SBWU600659SBWU600667SBWU600668SBWU600669SBWU600684SBWU600694SBWU600695SBWU600696SBWU600697SBWU600698SBWU600699SBWU600700SBWU600701SBWU600702SBWU600703SBWU600707SBWU600708SBWU600709SBWU600710SBWU600711SBWU600714SBWU600715SBWU600716SBWU600739SBWU600741SBWU600758S
- Lot Numbers
108 of 108 codes
BWU600776SBWU600721SBWU600810SBWU600771SBWU600772SBWU600774SBWU600723SBWU600795SBWU600820SBWU600720SBWU600782SBWU600768SBWU600719SBWU600793SBWU600717SBWU600718SBWU600722SBWU600726SBWU600727SBWU600728SBWU600729SBWU600730SBWU600735SBWU600778SBWU600807SBWU600808SBWU600809SBWU600813SBWU600814SBWU600815SBWU600816SBWU600817SBWU600819SBWU600821SBWU600822SBWU600830SBWU600831SBWU600833SBWU600834SBWU600835SBWU600836SBWU600704SBWU600705SBWU600736SBWU600767SBWU600806SBWU600848SBWU600849SBWU600850SBWU600870SBWU600876SBWU600936SBWU600937SBWU600939SBWU600940SBWU600941SBWU600769SBWU600770SBWU600841SBWU600845S
- Amount recalled
- 176 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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