Boston Scientific Corporation recalls SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the t…

Recall date

June 29, 2017

Source

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

Recall number

Z-3039-2017

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.

Why it was recalled

The device can deliver an atypical amount of energy due to memory corruption inside the device.

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

What was recalled

SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing