Reported Jun 28, 2023 · Ongoing
CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; 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 DTBB2QQ VIVA QUAD S IS4/DF4 INTLModel Number DTBB2QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720176
- Lot Serial Numbers
214 of 214 codes
BLP603514SBLP603579SBLP603583SBLP603637SBLP603643SBLP603554SBLP603588SBLP603580SBLP603582SBLP603584SBLP603585SBLP603586SBLP603591SBLP603531SBLP603552SBLP603511SBLP603647SBLP603581SBLP603545SBLP603551SBLP603569SBLP603648SBLP603808SBLP603536SBLP603538SBLP603542SBLP603543SBLP603544SBLP603546SBLP603549SBLP603550SBLP603553SBLP603555SBLP603557SBLP603558SBLP603562SBLP603563SBLP603576SBLP603577SBLP603587SBLP603641SBLP603670SBLP603671SBLP603672SBLP603673SBLP603674SBLP603675SBLP603676SBLP603677SBLP603678SBLP603729SBLP603730SBLP603732SBLP603733SBLP603734SBLP603735SBLP603736SBLP603409SBLP603529SBLP603533S
- Lot Serial Numbers
289 of 289 codes
BLP603685SBLP603811SBLP603812SBLP603911SBLP603949SBLP603950SBLP603951SBLP603952SBLP603958SBLP603846SBLP603862SBLP603815SBLP603816SBLP603838SBLP603863SBLP603865SBLP603953SBLP604008SBLP604022SBLP604036SBLP604051SBLP604060SBLP604065SBLP604067SBLP604091SBLP604101SBLP604102SBLP604110SBLP604113SBLP604115SBLP604119SBLP604144SBLP604145SBLP604148SBLP604155SBLP604156SBLP604173SBLP604114SBLP603954SBLP603956SBLP604019SBLP604028SBLP604002SBLP604003SBLP604004SBLP604005SBLP604007SBLP604014SBLP604015SBLP604030SBLP604034SBLP604035SBLP604037SBLP604039SBLP604041SBLP604042SBLP604043SBLP604044SBLP604045SBLP604047S
- Lot Serial Numbers
BLP604149SBLP604151SBLP604176SBLP604196SBLP604150SBLP604175SBLP604177SBLP604178SBLP604179SBLP604180SBLP604181SBLP604182SBLP604183SBLP604184SBLP604185SBLP604186SBLP604187SBLP604188SBLP604189SBLP604190SBLP604191SBLP604192S
- Amount recalled
- 523 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.
Want the full recall guide?
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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