Boston Scientific Corporation recalls Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable c…

Recall date

February 12, 2020

Source

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

Recall number

Z-1512-2020

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

US Nationwide distribution in the states of NC, TN, and MO.

Why it was recalled

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.

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

What was recalled

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.