Reported Jun 28, 2023 · Ongoing
CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; 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 DTBA2D1 VIVA XT IS1/DF1 INTLModel Number DTBA2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169217959
- Lot Serial Numbers
569 of 569 codes
BLJ622286SBLJ622571SBLJ622623SBLJ622733SBLJ622742SBLJ622966SBLJ624144SBLJ622126SBLJ624009SBLJ622569SBLJ623322SBLJ622064SBLJ622092SBLJ623468SBLJ623621SBLJ623849SBLJ624135SBLJ622023SBLJ623580SBLJ624033SBLJ623167SBLJ623490SBLJ622292SBLJ622241SBLJ623462SBLJ623794SBLJ623809SBLJ624193SBLJ621886SBLJ621947SBLJ622884SBLJ623297SBLJ623410SBLJ623471SBLJ624039SBLJ621718SBLJ622266SBLJ622481SBLJ622566SBLJ622575SBLJ622578SBLJ622582SBLJ622596SBLJ622621SBLJ622732SBLJ622903SBLJ622934SBLJ622973SBLJ623089SBLJ623300SBLJ623319SBLJ623411SBLJ623413SBLJ623482SBLJ623605SBLJ623615SBLJ623620SBLJ623631SBLJ623771SBLJ623960S
- Lot Serial Numbers
1,151 of 1,151 codes
BLJ622214SBLJ621360SBLJ621578SBLJ621580SBLJ621581SBLJ621582SBLJ621583SBLJ621584SBLJ621579SBLJ621692SBLJ621734SBLJ621809SBLJ622107SBLJ621831SBLJ621589SBLJ621591SBLJ621713SBLJ621654SBLJ621832SBLJ622104SBLJ622116SBLJ621838SBLJ622100SBLJ622102SBLJ621585SBLJ621836SBLJ621593SBLJ621596SBLJ621428SBLJ621439SBLJ621449SBLJ621453SBLJ621635SBLJ621644SBLJ621667SBLJ621672SBLJ621676SBLJ621846SBLJ621372SBLJ621572SBLJ621848SBLJ621586SBLJ621730SBLJ621731SBLJ621573SBLJ621619SBLJ621590SBLJ621843SBLJ621698SBLJ621703SBLJ621413SBLJ621361SBLJ622091SBLJ622235SBLJ621414SBLJ621524SBLJ621557SBLJ621823SBLJ621436SBLJ621367S
- Lot Serial Numbers
988 of 988 codes
BLJ622378SBLJ625786SBLJ625603SBLJ623541SBLJ625070SBLJ625131SBLJ626390SBLJ622383SBLJ622401SBLJ622551SBLJ623004SBLJ623555SBLJ623558SBLJ623565SBLJ622549SBLJ622709SBLJ622308SBLJ622313SBLJ622319SBLJ622328SBLJ622394SBLJ624431SBLJ622550SBLJ625486SBLJ625291SBLJ625339SBLJ622399SBLJ622450SBLJ624199SBLJ622380SBLJ622555SBLJ623362SBLJ623699SBLJ623903SBLJ622329SBLJ622444SBLJ623373SBLJ624631SBLJ624820SBLJ625730SBLJ622391SBLJ624212SBLJ624236SBLJ624311SBLJ624435SBLJ625583SBLJ622708SBLJ622541SBLJ623698SBLJ625287SBLJ623902SBLJ624091SBLJ624122SBLJ625715SBLJ622540SBLJ623918SBLJ624225SBLJ624235SBLJ624423SBLJ624938S
- Amount recalled
- 4354 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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