Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The Recalled by Boston Scientific CRM Corp Due to An internal protective fuse can be unintentionally activated...
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 CRM Corp directly.
Affected Products
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.
Quantity: 2090 (570 USA; 1520 OUS)
Why Was This Recalled?
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
Where Was This Sold?
This product was distributed to 17 states: AZ, CA, CO, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA, DC
About Boston Scientific CRM Corp
Boston Scientific CRM Corp has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report