Recall MonitorHealth ProductsType I recall
RELIANCE defibrillation leads
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: RELIANCE defibrillation leads
Issue: Medical devices - Performance
What to do: Healthcare professionals to conduct review of HVSI and determine if lead replacement is necessary.
Audience: General public, Healthcare
Recall class: Type I
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| RELIANCE 4-FRONT | More than 10 numbers, contact manufacturer. | 0696 |
| RELIANCE 4-FRONT | More than 10 numbers, contact manufacturer. | 0686 |
| RELIANCE 4-FRONT | More than 10 numbers, contact manufacturer. | 0692 |
| RELIANCE 4-FRONT | More than 10 numbers, contact manufacturer. | 0683 |
| RELIANCE 4-FRONT | More than 10 numbers, contact manufacturer. | 0693 |
| RELIANCE 4-FRONT | More than 10 numbers, contact manufacturer. | 0695 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0175 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0184 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0187 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0165 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0185 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0295 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0296 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0186 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0286 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0164 |
| ENDOTAK RELIANCE G | More than 10 numbers, contact manufacturer. | 0167 |
| ENDOTAK RELIANCE SG | More than 10 numbers, contact manufacturer. | 0181 |
| ENDOTAK RELIANCE SG | More than 10 numbers, contact manufacturer. | 0292 |
| ENDOTAK RELIANCE SG | More than 10 numbers, contact manufacturer. | 0161 |
| ENDOTAK RELIANCE SG | More than 10 numbers, contact manufacturer. | 0282 |
| ENDOTAK RELIANCE SG | More than 10 numbers, contact manufacturer. | 0283 |
| ENDOTAK RELIANCE SG | More than 10 numbers, contact manufacturer. | 0170 |
| ENDOTAK RELIANCE SG | More than 10 numbers, contact manufacturer. | 0293 |
| ENDOTAK RELIANCE SG | More than 10 numbers, contact manufacturer. | 0171 |
| ENDOTAK RELIANCE SG | More than 10 numbers, contact manufacturer. | 0180 |
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