GORE® ACUSEAL Vascular Graft
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
W.L. Gore & Associates Inc
1505 North 4th Street, Flagstaff, Arizona, United States, 86004
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