Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Recalled by Boston Scientific Corporation Due to Experienced accelerated battery depletion and a shortened replacement...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
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.
Quantity: 12,900
Why Was This Recalled?
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report