Recall MonitorHealth Products
GORE® ACUSEAL Vascular Graft
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: GORE® ACUSEAL Vascular Graft
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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