Reported Aug 31, 2016 · Terminated
Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4,…
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, Evera
- Implantable Cardioverter Defibrillators
Product Model EVERA XT DDBB1D1DDBB1D4DDBB2D1DDBB2D4DVBB2D4DVBB1D1. EVERA S DDBC3D1
- DDBC3D4 Product UsageThe Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardioverter defibrillator (lCD) are a family of multiprogrammable cardiac devices that monitor and regulate the patients heart rate by providing dual or single chamber rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies (dual-chamber devices only)
- Lot codes and dates
- Product NameEvera XT DR lCD
- Models
DDBB1D4DDBB1D1DDBB2D4DDBB2D1
- Serial Numbers
BWC202738HBWC202754HBWB202998HBWB203157HBWB203167HBWB203173HBWB203186HBWE601558SBWE601571SBWE601578SBWE601579SBWE601581SBWE601589SBWE601591SBWE601594SBWE601600SBWE601605SBWD602122S
- Product NameEvera S DR lCD
- Models
DDBC3D1DDBC3D4
- Serial Numbers
BWG600597SBWF600969SBWF600970SBWF600972SBWF600973SBWF600975SBWF600977SBWF600978SBWF600979SBWF600983SBWF600984SBWF600985SBWF600987SBWF600989SBWF600991SBWF600992SBWF600996SBWF601001S
- Product NameEvera XT VR lCD
- Models
DVBB1D1DVBB2D4
- Serial Numbers
BWI201423HBWI201436HBW1201440HBWI201451HBWI201454HBWI201462HBWI201473HBWJ601102SBWJ601108SBWJ601112SBWJ601479SBWJ601101SBWJ601103SBWJ601106S
- 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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