Reported Jun 28, 2023 · Ongoing
CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; 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 DTBA2Q1 VIVA QUAD XT IS4/DF1 INTLModel Number DTBA2Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169400603
- Lot Serial Numbers
117 of 117 codes
BLH605909SBLH605759SBLH605781SBLH605675SBLH605010SBLH605692SBLH605674SBLH605156SBLH605237SBLH605376SBLH605837SBLH605887SBLH605736SBLH605691SBLH605953SBLH604859SBLH605700SBLH605904SBLH605933SBLH605945SBLH605854SBLH605929SBLH605742SBLH605709SBLH605877SBLH605786SBLH605711SBLH605574SBLH605747SBLH605932SBLH604888SBLH605014SBLH605399SBLH605699SBLH605705SBLH605729SBLH605732SBLH605806SBLH605239SBLH605233SBLH605704SBLH605730SBLH605821SBLH605400SBLH605011SBLH605850SBLH605707SBLH605241SBLH605819SBLH605820SBLH605577SBLH605235SBLH604907SBLH605676SBLH605915SBLH605319SBLH605582SBLH605391SBLH605519SBLH605589S
- Lot Serial Numbers
434 of 434 codes
BLH605473SBLH604935SBLH604937SBLH605016SBLH605076SBLH605078SBLH605180SBLH605210SBLH605230SBLH605297SBLH605462SBLH605687SBLH604836SBLH604858SBLH604861SBLH604885SBLH604909SBLH604915SBLH604927SBLH604933SBLH604951SBLH605678SBLH604853SBLH605298SBLH604925SBLH605683SBLH604839SBLH604874SBLH604910SBLH604845SBLH605009SBLH604963SBLH604964SBLH604837SBLH604940SBLH604945SBLH604865SBLH604844SBLH604870SBLH604849SBLH604911SBLH604877SBLH604918SBLH604860SBLH605684SBLH604843SBLH605679SBLH604842SBLH604852SBLH605015SBLH604854SBLH605172SBLH605173SBLH605174SBLH605175SBLH605176SBLH605177SBLH605178SBLH605179SBLH605181S
- Lot Serial Numbers
583 of 583 codes
BLH606507SBLH606527SBLH606561SBLH606472SBLH606476SBLH606473SBLH606477SBLH605833SBLH605927SBLH605528SBLH605839SBLH605905SBLH605140SBLH605287SBLH605504SBLH605525SBLH605531SBLH605532SBLH605623SBLH605284SBLH605289SBLH605420SBLH605626SBLH605524SBLH605533SBLH605139SBLH606369SBLH606221SBLH606391SBLH606467SBLH606469SBLH605628SBLH605848SBLH605965SBLH606025SBLH605616SBLH605889SBLH606182SBLH605282SBLH605290SBLH605413SBLH605419SBLH605522SBLH605529SBLH605530SBLH605539SBLH605540SBLH605545SBLH605549SBLH605778SBLH605817SBLH605822SBLH605853SBLH605859SBLH605870SBLH605876SBLH605879SBLH605890SBLH605895SBLH605898S
- Amount recalled
- 1132 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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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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