Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure Due to 78 Viva CRT -Ds and Evera ICDs that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure directly.
Affected Products
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The 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.
Quantity: 78 (39 US, 39 OUS)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic Inc., Cardiac Rhythm and Heart Failure has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report