Reported Jun 28, 2023 · Ongoing
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; 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 DDBC3D1 EVERA S IS1/DF1 GLOBModel Number DDBC3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720411
- Lot Serial Numbers
422 of 422 codes
BWG208720HBWG208284HBWG208405HBWG208608HBWG208700HBWG208763HBWG208301HBWG208376HBWG208406HBWG208412HBWG208520HBWG208539HBWG208652HBWG208716HBWG208296HBWG208340HBWG208484HBWG208220HBWG208234HBWG208641HBWG208702HBWG208758HBWG208430HBWG208206HBWG208215HBWG208561HBWG208216HBWG208705HBWG208502HBWG208221HBWG208236HBWG208488HBWG208403HBWG208312HBWG208557HBWG208335HBWG208530HBWG208634HBWG208745HBWG208746HBWG208249HBWG208654HBWG208291HBWG208515HBWG208596HBWG208636HBWG208637HBWG208730HBWG208757HBWG208213HBWG208347HBWG208597HBWG208605HBWG208692HBWG208514HBWG208640HBWG208326HBWG208499HBWG208223HBWG208491H
- Lot Serial Numbers
1,008 of 1,008 codes
BWG606752SBWG606481SBWG606334SBWG606796SBWG606352SBWG606515SBWG606384SBWG606530SBWG606659SBWG606661SBWG606685SBWG606508SBWG606697SBWG606689SBWG606501SBWG606355SBWG606472SBWG606512SBWG606527SBWG606535SBWG606547SBWG606558SBWG606585SBWG606588SBWG606598SBWG606691SBWG606713SBWG606732SBWG606795SBWG606741SBWG606572SBWG606345SBWG606462SBWG606390SBWG606410SBWG606421SBWG606522SBWG606531SBWG606534SBWG606589SBWG606607SBWG607320SBWG606326SBWG606347SBWG606357SBWG606409SBWG606517SBWG606519SBWG606657SBWG606513SBWG606493SBWG606363SBWG606337SBWG606690SBWG606356SBWG606411SBWG606536SBWG606537SBWG606665SBWG606596S
- Lot Serial Numbers
1,278 of 1,278 codes
BWG607183SBWG607239SBWG607250SBWG608240SBWG607092SBWG607240SBWG607329SBWG606540SBWG606911SBWG607249SBWG607253SBWG608552SBWG608872SBWG609118SBWG610086SBWG610088SBWG610619SBWG610632SBWG611384SBWG611388SBWG610089SBWG606981SBWG607657SBWG608117SBWG608160SBWG607360SBWG607363SBWG608079SBWG607336SBWG607891SBWG607328SBWG607033SBWG606924SBWG607093SBWG607348SBWG607817SBWG606958SBWG606957SBWG606961SBWG606928SBWG606916SBWG607099SBWG607032SBWG606978SBWG607080SBWG607272SBWG607366SBWG608835SBWG607029SBWG607664SBWG607843SBWG608155SBWG608244SBWG608665SBWG608693SBWG608959SBWG610341SBWG606962SBWG606983SBWG607027S
- Amount recalled
- 5176 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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