Official recall record

RELIANCE defibrillation leads

Health Canada — Medical Devices · 2025-07-29 · CanadaType I

Issuing authority: Health Canada — Medical Devices
Published: 2025-07-29
Country of alert: Canada
Alert level: Type I
Alert type: recall

What the authority reported

Boston Scientific is initiating an advisory for ePTFE covered shock coil models from the RELIANCE family of defibrillation leads. The ePTFE material covering the shocking coils creates a matrix that, in some patients, promotes calcification, a biological wound response which is associated with gradual rising shock lead impedance (SLI) over time. Boston Scientific no longer manufactures or distributes ePTFE leads. Defibrillation leads currently distributed are non-ePTFE. Product is not being recalled. Recall start date: July 24, 2025

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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