Reported Jun 28, 2023 · Ongoing
ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; 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 DVMC3D1 EVERA MRI S OUS/US DF1Model Number DVMC3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837775
- Lot Serial Numbers
2,714 of 2,714 codes
CWF606066SCWF601772SCWF604835SCWF604967SCWF605332SCWF601390SCWF603522SCWF602774SCWF605900SCWF600919SCWF600938SCWF601256SCWF601551SCWF601593SCWF601753SCWF601934SCWF601936SCWF602109SCWF602581SCWF602772SCWF603413SCWF603447SCWF605891SCWF602270SCWF602324SCWF602338SCWF602553SCWF602554SCWF602674SCWF602675SCWF602677SCWF602751SCWF602752SCWF602816SCWF602823SCWF602996SCWF602998SCWF603000SCWF603013SCWF603171SCWF603174SCWF603319SCWF603361SCWF603362SCWF603363SCWF603393SCWF603406SCWF603408SCWF603718SCWF603720SCWF603721SCWF603829SCWF603830SCWF603831SCWF603832SCWF603925SCWF603931SCWF603944SCWF603996SCWF603999S
- Amount recalled
- 6525 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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