medical Class II Updated 2021-04-28

BIOTRONIK Inc recalls BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04

Recalled Product

BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Number 61091508 84702943 84730466 84730467 84730473 84731681 84732041 84733171 84733182 84733184 84733566 84733567 84733573 84733576 84733579 84733584 84733789 84733797 84734087 84734093 84734876 84734877 84735634 84735637 84735639 84735642 84737565 84737572 84737578 84737923 84738280 84738281 84738284 84738617 84738620 84738621 84739042 84739049 84739285 84739288 84740027 84740029 84740529 84740981 84741287 84741300 84741301 84741302 84741423 84741558 84741561 84741739 84741883 84741898 84742256 84742261 84743460 84743463 84743908 84743932 84744353 84746458 84746479 84749728 84749736 84753258 84754939 84755554 84755839 84756402 84756412 84761217 84761486 84761780
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