Reported Jun 28, 2023 · Ongoing
ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; 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 DVEX2E4 EV ICD OUS EV4Model Number DVEX2E4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000115647
- Lot Serial Numbers
EVR600484SEVR600487SEVR600488SEVR600489SEVR600490SEVR600492SEVR600494SEVR600479SEVR600480SEVR600483SEVR600500SEVR600495SEVR600496SEVR600478SEVR600516SEVR600517SEVR600519SEVR600521SEVR600522SEVR600525SEVR600526S
- Amount recalled
- 21 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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