medical Class II Updated 2020-03-25

Boston Scientific Corporation recalls Boston Scientific, Implantable Cardioverter Defibrillator, D

Recalled Product

Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.


Hazard / Issue

Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Number 516959
View official government recall

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