Recall Z-0474-2019— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2018-11-01, terminated 2019-11-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-01
- Terminated
- 2019-11-04
- Firm location
- Saint Paul, MN, United States
Product description
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.
Reason for recall
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.