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FDAMarch 8, 2021device

BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

biotronik

UPCs

04035479125202

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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