GORE® ACUSEAL Vascular Graft
Brand(s)
Last updated
Summary
Product
GORE® ACUSEAL Vascular Graft
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| GORE® ACUSEAL Vascular Graft | More than 10 numbers, contact manufacturer. | ECH060040 |
| GORE® ACUSEAL Vascular Graft | More than 10 numbers, contact manufacturer. | ECH060050 |
| GORE® ACUSEAL Vascular Graft | More than 10 numbers, contact manufacturer. | ECH060010 |
| GORE® ACUSEAL Vascular Graft | More than 10 numbers, contact manufacturer. | ECH060020 |
| GORE® ACUSEAL Vascular Graft | More than 10 numbers, contact manufacturer. | ECH470045 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
W.L. Gore & Associates Inc
1505 North 4th Street, Flagstaff, Arizona, United States, 86004
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-78003
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