Reported Jun 28, 2023 · Ongoing
ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; 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 DVME3D4 MIRRO MRIModel Number DVME3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000001629
- Lot Serial Numbers
2,714 of 2,714 codes
CWR601226SCWR601747SCWR614516SCWR615056SCWR611693SCWR610177SCWR613808SCWR600732SCWR606430SCWR602651SCWR607356SCWR610310SCWR604045SCWR603303SCWR609623SCWR605872SCWR601687SCWR603211SCWR602807SCWR607694SCWR613692SCWR613696SCWR605094SCWR610428SCWR606832SCWR607019SCWR612869SCWR614166SCWR614552SCWR608782SCWR611713SCWR614839SCWR613888SCWR614119SCWR614102SCWR614110SCWR613089SCWR612399SCWR608766SCWR614937SCWR612224SCWR614130SCWR612786SCWR614153SCWR613324SCWR612299SCWR612283SCWR612754SCWR610251SCWR610659SCWR604739SCWR605422SCWR605753SCWR606253SCWR607872SCWR609650SCWR613342SCWR606875SCWR601224SCWR601549S
- Amount recalled
- 14989 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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