W L Gore recalls ACUSEAL Vascular Graft models ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, and others due to reported delamination causing bleeding, bruising, and cannulation difficulties.
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.
W L Gore is recalling ACUSEAL Vascular Grafts with specific model numbers because they may delaminate, leading to reduced blood flow, bleeding, bruising, or complications during medical procedures. This recall is important for patients and healthcare providers using these grafts to prevent potential harm.
The grafts may delaminate, which means the layers of the graft can separate. This can cause reduced blood flow, make it harder to insert medical devices, and lead to bleeding or bruising. It may also complicate follow-up procedures.
Patients and healthcare providers who use the recalled ACUSEAL Vascular Grafts for medical procedures are most at risk, particularly those undergoing surgeries or treatments requiring vascular access.
Check the product's model number on the packaging or label. The recalled grafts have model numbers starting with ECH050020, ECH050050, ECH060010, ECH060020, ECH060040, ECH060050, or ECH460045. The serial number falls between 6597081PP001 and 9853822PP024.
Look for the model number on the graft packaging or label to confirm if it is in the recalled list.
Ensure you have the latest version of the Instructions for Use (MD183888 Revision 4) to follow updated safety guidelines.
W L Gore is recalling these vascular grafts due to reports of delamination, which can cause reduced blood flow, bleeding, bruising, and complications during medical procedures.
The affected model numbers include ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, and others as listed in the recall notice.
No, the recall does not require stopping use immediately. However, you should check if your product is affected and follow the updated Instructions for Use.
We’ve drafted a message you can send W L Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-0036-2026 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0036-2026 from W L Gore. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
