Official recall record

ACCOLADE™ MRI Pacemaker

Health Canada — Medical Devices · 2024-09-24 · CanadaType I

Issuing authority: Health Canada — Medical Devices
Published: 2024-09-24
Country of alert: Canada
Alert level: Type I
Alert type: recall

What the authority reported

Boston Scientific is retrieving specific model l331 ACCOLADE™ pacemakers due to inadvertent re-use/duplication of certain model/serial number combinations. This duplication occurred during the manufacturing of devices built over the past month. There are no performance concerns with these pacemakers, and they have passed all manufacturing tests. Additionally, there have been no reported adverse events or patient harms related to their use. Recall start date: September 12, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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