Boston Scientific Recalls SQ-RX 1010 Pulse Generators Due to Memory Corruption
Boston Scientific is recalling approximately 12,450 SQ-RX 1010 Pulse Generators because memory corruption may cause the device to deliver an atypical amount of energy.
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 recall is classified as FDA Class II, and the hazard involves a structural defect in a life-sustaining medical device that could deliver atypical energy, meeting the criteria for a Severe rating.
Plain-English summary
Boston Scientific Corporation is recalling approximately 12,450 SQ-RX 1010 Pulse Generators. These devices are part of the S-ICD system, which 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.
The recall is being conducted because the device can deliver an atypical amount of energy due to memory corruption inside the device. The affected units were distributed nationwide in the United States, including Puerto Rico, the U.S. Virgin Islands, and Guam, as well as in foreign countries including Canada.
Patients with these devices should contact their healthcare provider for further instructions. The recall number is Z-3039-2017.
The recalled product
- Product
- SQ-RX 1010 Pulse Generator, Rx. Product Usage: 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 spontan
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 12,450
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)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
Same hazard · electrical malfunction
See all →- SevereMicro Bird Recalls Transit Buses Due to Fire Risk from Loose Power Cable
NHTSA · 2025-12-05
- High
- SevereHeartMate Mobile Power Unit electrical malfunction may cause loss of power
FDA (Devices) · 2025-04-23
- Severe
- Severe