Official recall record
GORE® ACUSEAL Vascular Graft
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-08-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.