Reported Jun 28, 2023 · Ongoing
ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; 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 DVMB2D1 EVERA MRI XT OUS DF1Model Number DVMB2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837768
- Lot Serial Numbers
1,914 of 1,914 codes
CWE602084SCWE601758SCWE600712SCWE602003SCWE600626SCWE600766SCWE601482SCWE601602SCWE602520SCWE602570SCWE602622SCWE601590SCWE602288SCWE601918SCWE602150SCWE602184SCWE602565SCWE602589SCWE600926SCWE600588SCWE601390SCWE601395SCWE601481SCWE601541SCWE601612SCWE601749SCWE601831SCWE601843SCWE602038SCWE600874SCWE601632SCWE601996SCWE602041SCWE601792SCWE602396SCWE600375SCWE601990SCWE600553SCWE601369SCWE601392SCWE601766SCWE601769SCWE601695SCWE601401SCWE601470SCWE602016SCWE602094SCWE602195SCWE602495SCWE600746SCWE601256SCWE600733SCWE601348SCWE601487SCWE601524SCWE600350SCWE600974SCWE601438SCWE601700SCWE601989S
- Lot Serial Numbers
395 of 395 codes
CWE603085SCWE603057SCWE603044SCWE602837SCWE602954SCWE602775SCWE602960SCWE602824SCWE602904SCWE602731SCWE602917SCWE602894SCWE602895SCWE602913SCWE602921SCWE602658SCWE602635SCWE602834SCWE602835SCWE602924SCWE603016SCWE602914SCWE602687SCWE602796SCWE602721SCWE602709SCWE602689SCWE602801SCWE602639SCWE602916SCWE602365SCWE602366SCWE602634SCWE602638SCWE602667SCWE602725SCWE602726SCWE602732SCWE602733SCWE602761SCWE602803SCWE602810SCWE602888SCWE602890SCWE602891SCWE602893SCWE603036SCWE602705SCWE603013SCWE602949SCWE603105SCWE603037SCWE602896SCWE602897SCWE602901SCWE602838SCWE602911SCWE602833SCWE602836SCWE602880S
- Lot Serial Numbers
CWE603002SCWE603003SCWE603004S
- Amount recalled
- 2310 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.
Want the full recall guide?
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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