Reported Jun 28, 2023 · Ongoing
CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; 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 DTBA2QQ VIVA QUAD XT IS4/DF4 INTLModel Number DTBA2QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720169
- Lot Serial Numbers
1,118 of 1,118 codes
BLG624311SBLG624755SBLG625177SBLG625181SBLG625182SBLG625188SBLG625193SBLG625324SBLG625325SBLG625434SBLG625596SBLG625598SBLG625606SBLG625608SBLG625636SBLG625647SBLG625702SBLG625740SBLG625741SBLG625745SBLG625962SBLG626105SBLG626141SBLG624936SBLG624987SBLG624995SBLG625164SBLG625167SBLG625168SBLG625242SBLG625247SBLG625565SBLG625566SBLG625568SBLG625573SBLG625616SBLG625619SBLG625620SBLG625624SBLG625651SBLG625653SBLG625655SBLG625656SBLG625489SBLG625612SBLG625910SBLG624312SBLG625331SBLG624790SBLG624843SBLG624880SBLG624881SBLG624878SBLG625644SBLG624773SBLG625148SBLG625224SBLG624958SBLG625000SBLG624751S
- Lot Serial Numbers
1,593 of 1,593 codes
BLG626995SBLG628179SBLG628075SBLG628182SBLG627589SBLG625906SBLG626056SBLG626163SBLG626164SBLG626489SBLG626492SBLG626501SBLG626649SBLG626651SBLG626957SBLG626958SBLG626961SBLG627146SBLG627148SBLG627150SBLG627192SBLG627224SBLG627704SBLG628016SBLG626173SBLG626174SBLG626175SBLG626176SBLG626179SBLG626180SBLG626182SBLG626183SBLG626185SBLG626186SBLG626188SBLG626194SBLG626195SBLG626858SBLG626859SBLG626868SBLG626892SBLG626908SBLG626933SBLG627199SBLG627286SBLG626407SBLG626542SBLG626608SBLG626592SBLG626593SBLG626594SBLG626595SBLG626596SBLG626597SBLG626094SBLG626122SBLG627285SBLG625724SBLG626370SBLG625721S
- Amount recalled
- 2931 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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