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Reliance defibrillation leads
Official notice
29 Jul 2025
An official Health Canada notice concerns Reliance defibrillation leads. 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 Published 2025-07-29.
What to do now
Healthcare professionals to conduct review of HVSI and determine if lead replacement is necessary.
Recall number
77782
Official notice
2025-07-29
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Boston Scientific, Reliance Defibrillation Leads.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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