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All product recalls associated with W L Gore & Associates, Inc..
Total Recalls
21
Past Year
1
Class I (Serious)
0
Most Recent
Aug 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Due to packaging defects, sterility assurance and heparin activity may be compromised.