Pacemakers Recalled Due to Software Defect in Safety Mode Activation
Boston Scientific is recalling ACCOLADE and related pacemakers worldwide due to a software issue that may cause unintended Safety Mode activation in ambulatory settings when high battery impedance is detected.
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: FDA Class I recall of an implanted cardiac pacemaker with a software defect that may cause unintended mode activation in ambulatory settings. The Class I designation reflects serious potential health consequences, and the defect affects a critical life-sustaining device.
Plain-English summary
Boston Scientific Corporation is recalling the ACCOLADE DR SL MRI Model L311 and related pacemakers (including PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE models) distributed worldwide. The recall affects approximately 90,931 units identified by specific serial numbers.
The devices contain a software issue that may cause unintended activation of Safety Mode in ambulatory settings when high battery impedance is detected. Safety Mode is intended as a device protection mechanism, but its unintended activation outside of hospital settings could affect normal pacemaker function.
A software enhancement is available that is designed to prevent unintended Safety Mode activation due to high battery impedance state. Patients implanted with any of the affected pacemaker models should contact their healthcare provider or Boston Scientific to determine if their specific device is included in this recall and to obtain the available software fix.
The recalled product
- Product
- ACCOLADE DR SL MRI (Model L311)
- Manufacturer
- Boston Scientific Corporation
- Hazard
- software-defect
- safety-mode-activation
- battery-impedance-issue
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 (20)
- GTIN 00802526558962
- Serial Numbers: 200737
- 202944
- 203132
- 203273
- 203512
- 203621
- 203903
- 204448
- 204712
- 204767
- 204877
- 204938
- 205006
- 205007
- 205020
- 205029
- 205055
- 205063
- 205068
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03