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.
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 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
- Hazard
- device-malfunction
- battery-impedance
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
Distributed nationwide across the United States.
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