Reported Jun 28, 2023 · Ongoing
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; 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-DR DDBB1D1 EVERA XT IS1/DF1 USModel Number DDBB1D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720404
- Lot Serial Numbers
1,935 of 1,935 codes
BWC242988HBWC241999HBWC242338HBWC242392HBWC243112HBWC243417HBWC243633HBWC243786HBWC244004HBWC241880HBWC242816HBWC243834HBWC241861HBWC242999HBWC241742HBWC241891HBWC241930HBWC242022HBWC242027HBWC242157HBWC242236HBWC242463HBWC242464HBWC242466HBWC242482HBWC242567HBWC242583HBWC242645HBWC242697HBWC242718HBWC242721HBWC242804HBWC242997HBWC243009HBWC243043HBWC243095HBWC243211HBWC243216HBWC243245HBWC243258HBWC243378HBWC243488HBWC243489HBWC243590HBWC243657HBWC243711HBWC243743HBWC243863HBWC244033HBWC244161HBWC244282HBWC244431HBWC242166HBWC242897HBWC243484HBWC243570HBWC244218HBWC244438HBWC241690HBWC242739H
- Lot Serial Numbers
245 of 245 codes
BWC600290SBWC600209SBWC600374SBWC600188SBWC600372SBWC600203SBWC600274SBWC600143SBWC600232SBWC600267SBWC600273SBWC600288SBWC600147SBWC600051SBWC600343SBWC600245SBWC600291SBWC600253SBWC600348SBWC600222SBWC600223SBWC600219SBWC600235SBWC600182SBWC600260SBWC600277SBWC600365SBWC600128SBWC600308SBWC600391SBWC600094SBWC600158SBWC600168SBWC600295SBWC600241SBWC600045SBWC600230SBWC600063SBWC600066SBWC600067SBWC600069SBWC600193SBWC600278SBWC600261SBWC600307SBWC600347SBWC600237SBWC600178SBWC600192SBWC600115SBWC600200SBWC600101SBWC600180SBWC600138SBWC600262SBWC600275SBWC600251SBWC600271SBWC600131SBWC600329S
- Amount recalled
- 2179 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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