medical Class II Updated 2021-04-28

BIOTRONIK Inc recalls BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04

Recalled Product

BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - 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 61089430 84703220 84724608 84724622 84724623 84724625 84724786 84724793 84724809 84725291 84725310 84725318 84725332 84725340 84725641 84725655 84725745 84725773 84725774 84725784 84725790 84728481 84729774 84729990 84730000 84730092 84730133 84730723 84730740 84730741 84731227 84731461 84731469 84731838 84731848 84731849 84732339 84732353 84732359 84732360 84732587 84732885 84733496 84733757 84734018 84734027 84734047 84734065 84734106 84735588 84735595 84735608 84736377 84736703 84736705 84736732 84736952 84737029 84737035 84737561 84737864 84737892 84738265 84739242 84739719 84739727 84739735 84740051 84740058 84740061 84740065 84740069 84740083 84740093 84740481 84740482 84740484 84740489 84740721 84740735 84740741 84740746 84740759 84741676 84741696 84742209 84742220 84742525 84742533 84742538 84742544 84742550 84742828 84743250 84743516 84743517 84744326 84744871
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