Boston Scientific SQ-RX Subcutaneous Pulse Generators Recalled for Fuse Activation
Boston Scientific is recalling SQ-RX Model 1010 subcutaneous pulse generators because an internal fuse may activate unintentionally, preventing the device from delivering therapy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the failure of a life-sustaining medical device (defibrillator) to deliver therapy, which poses a significant risk of serious injury or death if a life-threatening arrhythmia occurs.
Plain-English summary
Boston Scientific CRM Corp is recalling 2,090 units of the SQ-RX Model 1010 subcutaneous pulse generators, part of the S-ICD System intended to treat life-threatening ventricular tachyarrhythmias. The recall affects devices distributed in the United States and 18 other countries, including Canada, the United Kingdom, and various European nations.
The recall is due to a defect where an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. If this occurs, the defibrillator will be unable to deliver therapy, communicate with the Q-TECH Model 2020 programmer, emit tones, or respond to magnet application.
Patients with these devices should contact their healthcare provider or Boston Scientific for instructions on how to proceed. The source text does not specify a deadline or specific consumer action steps beyond the general recall notice.
The recalled product
- Product
- Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
- Manufacturer
- Boston Scientific CRM Corp
Distribution
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