Reported Jun 28, 2023 · Ongoing
ICD CROME VR MRI DF4, Model Number DVPC3D4; 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 DF4Model Number DVPC3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178550
- Lot Serial Numbers
341 of 341 codes
RSH600068SRSH600173SRSH600239SRSH601126SRSH601127SRSH601883SRSH601888SRSH601444SRSH601463SRSH601537SRSH601538SRSH600064SRSH600099SRSH600174SRSH600175SRSH600228SRSH600275SRSH600276SRSH600889SRSH600903SRSH601415SRSH601522SRSH601873SRSH600071SRSH600906SRSH600922SRSH601034SRSH601041SRSH601123SRSH600007SRSH600082SRSH600110SRSH601765SRSH601894SRSH600236SRSH600264SRSH601531SRSH600057SRSH600124SRSH600181SRSH600211SRSH600827SRSH600887SRSH601024SRSH601036SRSH601366SRSH600902SRSH601519SRSH601520SRSH601751SRSH601753SRSH601754SRSH601805SRSH600814SRSH601139SRSH601355SRSH601407SRSH600147SRSH600101SRSH601443S
- Lot Serial Numbers
1,691 of 1,691 codes
RSH600544SRSH602201SRSH602205SRSH602187SRSH602191SRSH602043SRSH602058SRSH602229SRSH602230SRSH602008SRSH602010SRSH602059SRSH601390SRSH601312SRSH601994SRSH602288SRSH602472SRSH601278SRSH602470SRSH602305SRSH601371SRSH601372SRSH600644SRSH600640SRSH600793SRSH601383SRSH601716SRSH602301SRSH602159SRSH601868SRSH600589SRSH600762SRSH600639SRSH600651SRSH600659SRSH600692SRSH600694SRSH600766SRSH600975SRSH600648SRSH600763SRSH600929SRSH600930SRSH600948SRSH600959SRSH601245SRSH601303SRSH601373SRSH601398SRSH601247SRSH601253SRSH601255SRSH601292SRSH601402SRSH601404SRSH601405SRSH601760SRSH600864SRSH600942SRSH601231S
- Amount recalled
- 2031 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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