Vascular grafts recalled after delamination reports prompt instructions for use update
W. L. Gore is recalling 52,306 GORE ACUSEAL Vascular Grafts following reports of graft delamination, and is updating the instructions for use with expanded warnings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record reports delamination and describes the resulting patient harms as potential rather than confirmed.
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
- Affected units
- 52,306
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- REF/UDI-DI: ECH050020J/04993024010758
- ECH050020W/00733132635450
- ECH050050J/04993024010772
- ECH050050W/00733132635474
- ECH060010A/00733132622573
- ECH060020A/00733132622597
- ECH060020J/04993024009967
- ECH060020W/00733132634729
- ECH060040/00733132605347
- ECH060040A/00733132605354
- ECH060040W/00733132619719
- ECH060050A/00733132626960
- ECH060050J/04993024009981
- ECH460045A/00733132634811
- ECH460045J/04993024010789
- ECH470045/00733132626977
Distribution
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