RELIANCE defibrillation leads
Brand(s)
Summary
Healthcare professionals to conduct review of HVSI and determine if lead replacement is necessary.
Affected 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
Additional information
Details
| Boston Scientific Corporation |
| 4100 Hamline Avenue North, St. Paul, Minnesota, United States, 55112-5798 |
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