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Gore® acuseal vascular graft

Official notice

29 Aug 2025

Last checked

29 Aug 2025

Medium riskHealth Canada
Watch W.l Gore

An official Health Canada notice concerns Gore® acuseal vascular graft. The GORE® ACUSEAL Vascular Graft is composed of multiple layers. If delamination occurs (i.e., separation of layers), separated material may protrude into the lumen. Investigation into delamination events determined that updates to the IFU are necessary to provide more specificity regarding risks of delamination and techniques that may contribute to its occurrence. Recall start date: August 19, 2025 Published 2025-08-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

78003

Official notice

2025-08-29

The hazard

The GORE® ACUSEAL Vascular Graft is composed of multiple layers. If delamination occurs (i.e., separation of layers), separated material may protrude into the lumen. Investigation into delamination events determined that updates to the IFU are necessary to provide more specificity regarding risks of delamination and techniques that may contribute to its occurrence. Recall start date: August 19, 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

78003

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Affected products

Product 1

Affected products - GORE® ACUSEAL Vascular Graft, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - ECH060040

Product 2

Affected products - GORE® ACUSEAL Vascular Graft, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - ECH060050

Product 3

Affected products - GORE® ACUSEAL Vascular Graft, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - ECH060010

Product 4

Affected products - GORE® ACUSEAL Vascular Graft, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - ECH060020

Product 5

Affected products - GORE® ACUSEAL Vascular Graft, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - ECH470045

Risk / hazard

The GORE® ACUSEAL Vascular Graft is composed of multiple layers. If delamination occurs (i.e., separation of layers), separated material may protrude into the lumen. Investigation into delamination events determined that updates to the IFU are necessary to provide more specificity regarding risks of delamination and techniques that may contribute to its occurrence. Recall start date: August 19, 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

W.l Gore, Gore® Acuseal Vascular Graft

Manufacturer

Not provided

Phone

Not provided

Brand: W.l Gore, Gore® Acuseal Vascular Graft.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

78003

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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