Vascular grafts recalled after delamination reports prompt instructions for use update

Plain-English summary

GORE ACUSEAL Vascular Grafts, covering references including ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045 and ECH470045A, are being recalled.

The firm reports vascular graft delamination, which may lead to reduced access flow, cannulation difficulties, bleeding or bruising, and harms related to reintervention procedures. The Instructions for Use will be updated to further clarify techniques that may contribute to the risk of delamination, and to add delamination to the device-related adverse event section.

The recall covers 52,306 units, distributed across states including Oregon, Alabama, Ohio, Maryland, Virginia, California, Florida, North Carolina, Oklahoma, Massachusetts, Missouri, Arizona, Texas, Illinois, Georgia, Pennsylvania, New Hampshire, Hawaii, Minnesota, Mississippi, Kentucky, Idaho, Louisiana, New Jersey, Tennessee, Delaware and Indiana. The FDA has classified the action as Class II.

Clinicians should follow the updated instructions for use once issued.

The recalled product

Product

GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.

Manufacturer

W L Gore & Associates, Inc.

Category

Medical Device — Vascular graft

Hazard

• delamination
• reduced-flow
• bleeding-risk
• labeling-update

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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