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.
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 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…
- 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
Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · battery malfunction
See all →- CriticalLife2000 Ventilation System battery charger defect causes device inoperability
FDA (Devices) · 2025-01-22
- SevereAmbulatory Infusion System Batteries May Short Circuit and Overheat
FDA (Devices) · 2024-11-06
- HighLIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins
FDA (Devices) · 2023-11-22
- HighLIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Failure
FDA (Devices) · 2023-11-22
- HighLIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss
FDA (Devices) · 2023-11-22
Similar recalls
- SevereBoston Scientific SQ-RX Subcutaneous Pulse Generators Recalled for Fuse Activation
FDA (Devices) · 2013-03-27
- SevereBoston Scientific Recalls SQ-RX 1010 Pulse Generators Due to Memory Corruption
FDA (Devices) · 2017-08-23
- ModerateBoston Scientific SQ-RX Subcutaneous Pulse Generator Recall for Telemetry Issues
FDA (Devices) · 2015-11-18
- SevereBoston Scientific Recalls Emblem S-ICD Devices Due to Energy Delivery Risk
FDA (Devices) · 2017-08-23
- HighBoston Scientific Recalls S-ICD Devices Due to Battery Depletion
FDA (Devices) · 2019-09-25
- HighBoston Scientific Recalls 28 Subcutaneous Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-09-25