Boston Scientific Recalls SQ-RX Pulse Generators for Battery Malfunctions
Boston Scientific is recalling 12,900 SQ-RX Pulse Generators used in S-ICD systems due to latent internal battery malfunctions that cause accelerated depletion.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. The product is a life-sustaining medical device (ICD) where battery failure poses a significant risk of harm, meeting the criteria for a Severe rating.
Plain-English summary
Boston Scientific Corporation is recalling 12,900 units of the SQ-RX Pulse Generator, Model 1010. This device is a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, which is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in specific patients.
The recall is being conducted because the pulse generators experienced accelerated battery depletion and a shortened replacement interval. This issue is attributed to latent internal battery malfunctions.
The affected units were distributed nationwide across all 50 U.S. states, the District of Columbia, and Puerto Rico. Patients with these devices should contact their healthcare providers or Boston Scientific for further instructions regarding the recall.
The recalled product
- 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 sympto
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 12,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- SQ-RX Pulse Generator Model 1010
Distribution
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