W L Gore & Associates recalled over 52,000 vascular grafts on August 26, 2025, due to reports of delamination. The defect can lead to severe complications such as bleeding or cannulation difficulties. Affected products include multiple model numbers, which were distributed across the United States and internationally.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact W L Gore & Associates, Inc. or your healthcare provider for instructions. Notification method: Letter
The recall affects GORE ACUSEAL Vascular Grafts with reference numbers including ECH050020J, ECH050050W, and ECH060040. These devices were sold to healthcare providers and facilities in the U.S. and multiple countries including Canada, Germany, and the United Kingdom.
Reports indicate that delamination of the vascular grafts may result in reduced access flow, bleeding, and complications requiring further medical intervention. The FDA classified this recall as Class II, indicating a potential for serious adverse health consequences.
There have been no specific incident or injury counts reported in the recall notice. However, the potential risks include serious complications related to cannulation difficulties and the need for reintervention.
Patients and healthcare providers should immediately stop using the device. Follow the recall instructions from the manufacturer and contact W L Gore & Associates, Inc. for further guidance.
For assistance, contact W L Gore & Associates, Inc. directly. Visit their website or refer to the recall link for more information.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.