Reported Jun 28, 2023 · Ongoing
CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; 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 DTBA1QQ VIVA QUAD XT IS4/DF4 USModel Number DTBA1QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720138
- Lot Serial Numbers
640 of 640 codes
BLC228471HBLC228476HBLC228533HBLC228541HBLC228635HBLC228702HBLC228745HBLC228827HBLC228830HBLC228840HBLC228872HBLC227820HBLC228658HBLC228889HBLC228890HBLC228895HBLC228896HBLC228900HBLC228350HBLC228567HBLC228738HBLC229053HBLC229197HBLC229064HBLC228295HBLC228587HBLC228382HBLC228585HBLC228296HBLC228583HBLC228787HBLC228926HBLC229106HBLC228579HBLC228245HBLC228551HBLC228625HBLC228819HBLC228440HBLC228622HBLC228825HBLC228456HBLC228432HBLC228960HBLC229166HBLC228545HBLC228676HBLC228695HBLC228573HBLC229089HBLC228721HBLC228898HBLC228980HBLC229099HBLC228302HBLC228256HBLC228258HBLC228300HBLC228319HBLC228355H
- Lot Serial Numbers
342 of 342 codes
BLC600191SBLC600409SBLC600416SBLC600443SBLC600449SBLC600318SBLC600054SBLC600157SBLC600175SBLC600354SBLC600482SBLC600383SBLC600533SBLC600129SBLC600062SBLC600357SBLC600433SBLC600083SBLC600505SBLC600205SBLC600479SBLC600499SBLC600060SBLC600323SBLC600372SBLC600489SBLC600085SBLC600506SBLC600081SBLC600349SBLC600199SBLC600200SBLC600437SBLC600300SBLC600182SBLC600186SBLC600311SBLC600188SBLC600467SBLC600026SBLC600185SBLC600494SBLC600140SBLC600336SBLC600469SBLC600075SBLC600355SBLC600388SBLC600305SBLC600287SBLC600405SBLC600406SBLC600037SBLC600120SBLC600353SBLC600414SBLC600448SBLC600462SBLC600445SBLC600363S
- Amount recalled
- 891 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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