Gore recalled 52,306 Gore ACUSEAL Vascular Grafts distributed through healthcare providers in the United States and internationally after reports of graft delamination. Delamination may reduce access flow, cause cannulation difficulties, bleeding or bruising, and may require reinterventions. Healthcare facilities and patients should stop using the device immediately and follow the recall guidance.
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
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Gore ACUSEAL Vascular Grafts are used in vascular access procedures to create or repair grafts in patients. The devices are designed for durable vascular repair and access.
Delamination can compromise graft integrity, reducing flow and complicating cannulation. This increases the risk of bleeding and may require additional procedures.
This recall is not identified as part of a broader industry pattern.
Affected patients may require monitoring, additional interventions, and coordination with healthcare teams. Hospitals should review devices on hand and ensure staff follow the updated warnings.
Identification details appear on device labels and accompanying IFU MD183888 Revision 4; recall notices provide serial ranges
Recall processing and replacement guidance may take weeks to months and will be coordinated through healthcare providers
Keep the recall letter, device labels, model and serial numbers, purchase records, and all correspondence with Gore or healthcare providers.
Model numbers: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A. Serial-number range: 6597081PP001 to 9853822PP024. Instructions for Use: MD183888 Revision 4. Quantity recalled: 52,306. Recall date: 2025-08-26. Status: Active. Distribution: United States and international markets.
No injuries or incidents have been reported.
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