BIOTRONIK Inc recalls BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tac…

Recall date

March 8, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1455-2021

FDA classification

Class II

Brand / firm

BIOTRONIK Inc

Sold / distributed

US: Nationwide OUS: Worldwide

Why it was recalled

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.