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
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