Reported Jun 28, 2023 · Ongoing
CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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 DTBC2QQ BRAVA QUAD IS4/DF4 INTLModel Number DTBC2QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720183
- Lot Serial Numbers
2,578 of 2,578 codes
BLX611513SBLX610983SBLX610727SBLX609800SBLX610700SBLX611193SBLX611227SBLX610459SBLX613336SBLX611231SBLX610972SBLX610821SBLX611566SBLX611238SBLX610596SBLX610449SBLX610925SBLX611306SBLX610523SBLX611147SBLX611439SBLX610568SBLX611464SBLX611546SBLX611733SBLX611813SBLX612082SBLX612083SBLX612440SBLX611069SBLX611190SBLX611293SBLX610441SBLX611452SBLX610586SBLX610739SBLX611422SBLX610467SBLX610671SBLX611002SBLX611400SBLX611499SBLX611540SBLX611542SBLX611554SBLX611561SBLX611732SBLX610299SBLX611218SBLX611398SBLX611547SBLX611549SBLX611565SBLX611613SBLX610991SBLX611110SBLX611987SBLX610490SBLX611737SBLX610446S
- Lot Serial numbers
133 of 133 codes
BLX618413SBLX615318SBLX612363SBLX614230SBLX617159SBLX617786SBLX618725SBLX612478SBLX613795SBLX614692SBLX615934SBLX616100SBLX616177SBLX616348SBLX615460SBLX612705SBLX614525SBLX613485SBLX614139SBLX614141SBLX614150SBLX614660SBLX615036SBLX612882SBLX616031SBLX612011SBLX612169SBLX613206SBLX613506SBLX614140SBLX614142SBLX614492SBLX613610SBLX612756SBLX613355SBLX611857SBLX614691SBLX615008SBLX615966SBLX613267SBLX615914SBLX616551SBLX615239SBLX612660SBLX612860SBLX612905SBLX614515SBLX614887SBLX614888SBLX614516SBLX616295SBLX612909SBLX611868SBLX613184SBLX613955SBLX614205SBLX613660SBLX613805SBLX614176SBLX614196S
- Amount recalled
- 7994 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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