Reported Jun 28, 2023 · Ongoing
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; 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 CROME VR MRI IS1 DF1Model Number DVPC3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178536
- Lot Serial Numbers
114 of 114 codes
RSG600215SRSG600106SRSG600196SRSG600208SRSG600223SRSG600280SRSG600125SRSG600193SRSG600006SRSG600016SRSG600123SRSG600136SRSG600573SRSG600113SRSG600249SRSG600395SRSG600579SRSG600173SRSG600111SRSG600112SRSG600116SRSG600118SRSG600130SRSG600143SRSG600175SRSG600191SRSG600205SRSG600209SRSG600272SRSG600564SRSG600167SRSG600187SRSG600077SRSG600131SRSG600145SRSG600162SRSG600245SRSG600253SRSG600512SRSG600519SRSG600037SRSG600536SRSG600544SRSG600210SRSG600643SRSG600642SRSG600122SRSG600138SRSG600174SRSG600200SRSG600225SRSG600233SRSG600585SRSG600134SRSG600168SRSG600148SRSG600132SRSG600240SRSG600055SRSG600121S
- Lot Serial Numbers
397 of 397 codes
RSG600567SRSG600684SRSG600753SRSG600654SRSG600347SRSG600349SRSG600833SRSG600842SRSG600829SRSG600700SRSG600705SRSG600730SRSG600362SRSG600868SRSG600729SRSG600803SRSG600313SRSG600584SRSG600688SRSG600827SRSG600079SRSG600306SRSG600103SRSG600105SRSG600317SRSG600474SRSG600741SRSG600379SRSG600529SRSG600656SRSG600657SRSG600674SRSG600738SRSG600330SRSG600380SRSG600063SRSG600315SRSG600316SRSG600334SRSG600335SRSG600476SRSG600572SRSG600673SRSG600332SRSG600333SRSG600619SRSG600311SRSG600444SRSG600050SRSG600070SRSG600320SRSG600652SRSG600052SRSG600327SRSG600609SRSG600582SRSG600371SRSG600319SRSG600089SRSG600477S
- Amount recalled
- 510 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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