Reported Jun 28, 2023 · Ongoing
CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; 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?
CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTLModel Number DTBC2Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720244
- Lot Serial Numbers
406 of 406 codes
BLY602416SBLY602685SBLY602482SBLY602743SBLY602431SBLY602548SBLY602563SBLY602693SBLY602474SBLY602424SBLY602465SBLY602812SBLY602676SBLY602445SBLY602572SBLY602497SBLY602549SBLY602715SBLY602735SBLY602531SBLY602657SBLY603005SBLY602489SBLY602628SBLY602652SBLY602459SBLY602483SBLY602576SBLY602450SBLY602521SBLY602574SBLY602680SBLY602386SBLY602463SBLY602694SBLY602747SBLY602449SBLY602401SBLY602413SBLY602432SBLY602631SBLY602633SBLY602672SBLY602740SBLY602741SBLY602403SBLY602412SBLY602517SBLY602528SBLY602430SBLY602501SBLY602270SBLY602552SBLY602713SBLY602478SBLY602543SBLY602443SBLY602464SBLY602634SBLY602421S
- Lot Serial Numbers
1,341 of 1,341 codes
BLY604417SBLY603039SBLY603408SBLY603693SBLY604021SBLY604048SBLY604373SBLY603363SBLY603646SBLY603660SBLY603917SBLY604062SBLY604210SBLY603834SBLY604045SBLY603409SBLY602787SBLY602946SBLY604029SBLY604226SBLY603599SBLY604103SBLY603419SBLY603175SBLY603428SBLY603657SBLY602776SBLY602935SBLY603848SBLY604049SBLY603829SBLY603939SBLY604187SBLY603598SBLY603434SBLY603875SBLY603978SBLY604044SBLY602760SBLY602948SBLY603438SBLY603611SBLY603720SBLY603048SBLY603256SBLY603566SBLY602855SBLY602920SBLY602958SBLY603269SBLY603351SBLY603262SBLY603457SBLY602858SBLY602941SBLY602966SBLY603114SBLY603581SBLY602799SBLY603146S
- Lot Serial Numbers
BLY604454SBLY604464SBLY604463SBLY604461SBLY604462SBLY604465SBLY604466SBLY604467SBLY604468S
- Amount recalled
- 1754 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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