Back to RecallTracker
Health Canada Medical devices

RELIANCE defibrillation leads

Issued July 29, 2025
Issue
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
Hazard description
Performance
Product
Product name
RELIANCE defibrillation leads
Reference
ID
RA-77782