Reported Jun 28, 2023 · Ongoing
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; 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 DVFB2D1 VISIA AF MRI XT OUS DF1Model Number DVFB2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837805
- Lot Serial Numbers
2,714 of 2,714 codes
CWH604762SCWH602704SCWH604287SCWH601113SCWH602355SCWH601417SCWH601422SCWH601423SCWH603581SCWH602459SCWH602700SCWH601632SCWH601887SCWH602686SCWH602952SCWH603048SCWH604506SCWH604849SCWH605365SCWH605366SCWH605549SCWH602311SCWH603176SCWH603389SCWH601114SCWH601326SCWH601494SCWH601599SCWH601907SCWH601934SCWH602005SCWH602031SCWH602068SCWH602379SCWH602640SCWH602643SCWH602875SCWH602966SCWH603029SCWH603161SCWH603186SCWH604179SCWH604365SCWH604848SCWH605143SCWH605152SCWH605229SCWH605231SCWH601040SCWH601241SCWH602091SCWH602139SCWH602556SCWH602717SCWH603107SCWH603227SCWH603322SCWH603327SCWH603472SCWH603986S
- Amount recalled
- 4546 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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