Reported Aug 31, 2016 · Terminated
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4…
Medtronic Inc., Cardiac Rhythm and Heart Failure
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · 8200 Coral Sea St NE · Mounds View, MN · 55112-4391
Is this the product you have?
- Medtronic, Viva Quadripolar
- Implantable Cardioverter Defibrillators
Product Model VIVAXTCRT-D DTBA1D1DTBA1D4 VIVASCRT-D DTBB1D1
- DTBB1D4 Product UsageThe Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies
- Lot codes and dates
- Product NameViva XT CRT -D
- Models
DTBA1D4DTBA1D1
- Serial Numbers
BLF203128HBLF204746HBLE202888HBLE202889HBLE202890HBLE202901HBLE202941HBLE202947HBLE202954HBLE202958HBLE202961HBLE202962HBLE202964HBLE202981HBLE202987HBLE202989HBLE202990HBLE202991HBLE203019HBLE203026HBLE203027HBLE203029HBLE203032HBLE203046HBLE203052H
- BLE203073H Product NameViva S CRT-D
- Models
DTBB1D4DTBB1D1
- Serial Numbers
BLO202272HBLN202206H
- Amount recalled
- 78 (39 US, 39 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
This product could cause temporary or reversible health problems — stop using it.
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