ACCOLADE DR Pacemakers Recalled for Unintended Safety Mode Activation
Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I recall designation mandates a minimum severity score of 4. The hazard involves implantable pacemakers potentially malfunctioning during routine telemetry operations due to battery impedance, which poses a risk to device function, though no injuries or deaths are reported in the source.
Plain-English summary
Boston Scientific is recalling a subset of ACCOLADE DR Pacemakers (models L301, L311, L321, and L331) manufactured before September 2018. Approximately 156,329 units have been distributed worldwide, including in the United States and its territories.
These devices have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance. Safety Mode activation during these routine operations could affect normal device function.
Patients with ACCOLADE DR Pacemakers should contact their healthcare provider to verify whether their device is included in this recall and discuss appropriate next steps.
The recalled product
- Product
- ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
- Manufacturer
- Boston Scientific Corporation
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 (2)
- L301 - UDI-DI: 00802526559174
- 00802526559181
Distribution
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- 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
Same hazard · device malfunction
See all →- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim SureScan MRI Leads Recalled for Incompatible Selection
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim Percutaneous Extensions Recalled for Incompatible Lead Selection
FDA (Devices) · 2026-10-28
- SevereVentec Ventilator Cable Recall Due to Potential Disconnection
FDA (Devices) · 2026-10-28
- SevereVentec VC+Pro Ventilator Recalled for Potential Connector Disconnection
FDA (Devices) · 2026-10-28
Similar recalls
- CriticalACCOLADE dual chamber MRI pacemakers recalled for Safety Mode software update
FDA (Devices) · 2025-10-22
- CriticalACCOLADE dual chamber extended life MRI pacemakers recalled for software update
FDA (Devices) · 2025-10-22
- CriticalACCOLADE single chamber pacemakers recalled for Safety Mode software update
FDA (Devices) · 2025-10-22
- CriticalACCOLADE dual chamber standard life pacemakers recalled for software update
FDA (Devices) · 2025-10-22
- CriticalPacemakers recalled for software update preventing Safety Mode from battery impedance
FDA (Devices) · 2025-10-22
- CriticalACCOLADE single chamber standard life pacemakers recalled for software update
FDA (Devices) · 2025-10-22