Reported Jun 28, 2023 · Ongoing
CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; 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 DTBA1Q1 VIVA QUAD XT IS4/DF1 USModel Number DTBA1Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720190
- Lot Serial Numbers
373 of 373 codes
BLD212440HBLD212962HBLD212366HBLD212449HBLD212473HBLD212554HBLD212653HBLD212675HBLD212791HBLD212822HBLD212902HBLD212926HBLD213003HBLD213009HBLD212351HBLD212699HBLD212811HBLD212406HBLD212432HBLD212306HBLD212443HBLD212455HBLD212472HBLD212600HBLD212644HBLD212839HBLD212920HBLD212943HBLD212349HBLD212311HBLD212708HBLD212781HBLD212834HBLD212521HBLD212566HBLD212628HBLD212648HBLD212782HBLD212883HBLD213061HBLD212483HBLD212487HBLD213006HBLD212452HBLD212752HBLD213012HBLD212357HBLD212333HBLD212570HBLD212638HBLD212709HBLD212830HBLD212915HBLD212953HBLD212984HBLD212996HBLD213030HBLD213041HBLD212586HBLD212459H
- Amount recalled
- 373 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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