medical Class II Updated 2018-11-28

Boston Scientific Corporation recalls The SQ-RX Pulse Generator a component of the Subcutaneous Im

Recalled Product

The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System 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.


Hazard / Issue

Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: SQ-RX Pulse Generator Model 1010
View official government recall

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