Reported Jun 28, 2023 · Ongoing
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; 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 DDBB2D1 EVERA XT IS1/DF1 INTLModel Number DDBB2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169217911
- Lot Serial Numbers
328 of 328 codes
BWE613480SBWE613110SBWE613432SBWE613202SBWE613100SBWE613096SBWE613185SBWE613258SBWE613431SBWE612802SBWE612865SBWE613214SBWE613235SBWE612884SBWE612956SBWE613098SBWE613122SBWE613143SBWE613171SBWE613212SBWE613216SBWE613251SBWE613470SBWE613162SBWE613238SBWE613459SBWE613430SBWE613153SBWE613484SBWE613168SBWE612948SBWE612950SBWE612970SBWE613487SBWE613090SBWE613224SBWE613180SBWE613077SBWE612815SBWE612940SBWE613086SBWE612721SBWE613194SBWE612880SBWE613125SBWE613221SBWE612822SBWE612985SBWE612928SBWE613446SBWE612939SBWE612837SBWE613097SBWE613095SBWE613104SBWE613211SBWE613463SBWE613460SBWE612679SBWE612960S
- GTIN00643169969568
- Lot Serial Numbers
764 of 764 codes
BWE612952SBWE613091SBWE613094SBWE613297SBWE613299SBWE613316SBWE613326SBWE613429SBWE613589SBWE613591SBWE613597SBWE613659SBWE613664SBWE613775SBWE612704SBWE612717SBWE613092SBWE613138SBWE613343SBWE612681SBWE612692SBWE613007SBWE612666SBWE612667SBWE612687SBWE612647SBWE612803SBWE613232SBWE613307SBWE613490SBWE612646SBWE613285SBWE612732SBWE613217SBWE613237SBWE613287SBWE613289SBWE613300SBWE613344SBWE613489SBWE613301SBWE613165SBWE613246SBWE613206SBWE613495SBWE613598SBWE613227SBWE613230SBWE612658SBWE613497SBWE612657SBWE613354SBWE612730SBWE613269SBWE613588SBWE612690SBWE613132SBWE612782SBWE613341SBWE612421S
- Lot Serial Numbers
1,191 of 1,191 codes
BWE614420SBWE614714SBWE615090SBWE615173SBWE615194SBWE613896SBWE613897SBWE613898SBWE614007SBWE614008SBWE614025SBWE614263SBWE614351SBWE614362SBWE614363SBWE614364SBWE614399SBWE614424SBWE614552SBWE614629SBWE614931SBWE615001SBWE615022SBWE615023SBWE615177SBWE615188SBWE614404SBWE614538SBWE615020SBWE614300SBWE613684SBWE614341SBWE613741SBWE613780SBWE614278SBWE614375SBWE614548SBWE613534SBWE613779SBWE613781SBWE613954SBWE613526SBWE613674SBWE613678SBWE613751SBWE613783SBWE614037SBWE614949SBWE613729SBWE614438SBWE614383SBWE614384SBWE614436SBWE614437SBWE613536SBWE613734SBWE613782SBWE615019SBWE613754SBWE614160S
- Amount recalled
- 2282 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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