Reported Jun 28, 2023 · Ongoing
ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; 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 DDBB2D4 EVERA XT IS1/DF4 INTLModel Number DDBB2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169217928
- Lot Serial Numbers
89 of 89 codes
BWD609356SBWD609450SBWD609318SBWD609387SBWD609454SBWD609558SBWD609464SBWD609549SBWD609355SBWD609467SBWD609389SBWD609343SBWD609397SBWD609567SBWD609395SBWD609462SBWD609470SBWD609316SBWD609554SBWD609551SBWD609594SBWD609391SBWD609466SBWD609560SBWD609473SBWD609288SBWD609322SBWD609352SBWD609360SBWD609465SBWD609476SBWD609547SBWD609363SBWD609472SBWD609573SBWD609319SBWD609526SBWD609570SBWD609448SBWD609370SBWD609320SBWD609367SBWD609317SBWD609368SBWD609371SBWD609385SBWD609362SBWD609373SBWD609381SBWD609346SBWD609574SBWD609572SBWD609365SBWD609357SBWD609348SBWD609451SBWD609568SBWD609386SBWD609344SBWD609468S
- Lot Serial Numbers
270 of 270 codes
BWD609418SBWD609419SBWD609420SBWD609421SBWD609422SBWD609423SBWD609424SBWD609425SBWD609426SBWD609427SBWD609428SBWD609429SBWD609430SBWD609431SBWD609432SBWD609433SBWD609434SBWD609435SBWD609437SBWD609438SBWD609439SBWD609440SBWD609441SBWD609442SBWD609443SBWD609471SBWD609331SBWD609315SBWD609295SBWD609313SBWD609576SBWD609690SBWD609323SBWD609222SBWD609587SBWD609492SBWD609520SBWD609328SBWD609407SBWD609408SBWD609513SBWD609609SBWD609625SBWD609404SBWD609332SBWD609563SBWD609602SBWD609605SBWD609475SBWD609483SBWD609484SBWD609564SBWD609565SBWD609495SBWD609510SBWD609519SBWD609536SBWD609584SBWD609598SBWD609762S
- Lot Serial Numbers
369 of 369 codes
BWD609982SBWD609997SBWD610057SBWD610087SBWD609770SBWD609970SBWD609798SBWD609875SBWD609877SBWD610151SBWD609889SBWD610004SBWD610036SBWD609623SBWD609991SBWD610045SBWD610051SBWD610052SBWD610040SBWD610041SBWD609800SBWD609650SBWD609702SBWD609741SBWD610097SBWD610199SBWD610061SBWD609646SBWD610058SBWD610142SBWD610143SBWD610144SBWD610145SBWD610149SBWD610150SBWD610157SBWD610161SBWD610197SBWD610205SBWD610206SBWD610207SBWD610208SBWD610210SBWD610211SBWD610212SBWD610213SBWD610214SBWD610216SBWD610226SBWD610227SBWD610228SBWD610229SBWD610259SBWD610265SBWD610134SBWD610141SBWD609647SBWD610133SBWD610148SBWD610158S
- Lot Serial Numbers
BWD610291SBWD610248S
- Amount recalled
- 727 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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