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Reliance defibrillation leads

Official notice

29 Jul 2025

Last checked

29 Jul 2025

Critical riskHealth Canada
Watch Boston Scientific

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

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

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

77782

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Affected products

Product 1

Affected products - RELIANCE 4-FRONT, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0696

Product 2

Affected products - RELIANCE 4-FRONT, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0686

Product 3

Affected products - RELIANCE 4-FRONT, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0692

Product 4

Affected products - RELIANCE 4-FRONT, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0683

Product 5

Affected products - RELIANCE 4-FRONT, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0693

Product 6

Affected products - RELIANCE 4-FRONT, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0695

Product 7

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0175

Product 8

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0184

Product 9

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0187

Product 10

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0165

Product 11

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0185

Product 12

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0295

Product 13

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0296

Product 14

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0186

Product 15

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0286

Product 16

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0164

Product 17

Affected products - ENDOTAK RELIANCE G, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0167

Product 18

Affected products - ENDOTAK RELIANCE SG, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0181

Product 19

Affected products - ENDOTAK RELIANCE SG, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0292

Product 20

Affected products - ENDOTAK RELIANCE SG, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0161

Product 21

Affected products - ENDOTAK RELIANCE SG, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0282

Product 22

Affected products - ENDOTAK RELIANCE SG, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0283

Product 23

Affected products - ENDOTAK RELIANCE SG, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0170

Product 24

Affected products - ENDOTAK RELIANCE SG, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0293

Product 25

Affected products - ENDOTAK RELIANCE SG, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0171

Product 26

Affected products - ENDOTAK RELIANCE SG, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0180

Risk / 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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Boston Scientific, Reliance Defibrillation Leads

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific, Reliance Defibrillation Leads.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

critical

Recall details

Recall number

77782

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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