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.
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
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.. Reason: 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.. Classification: Class II. Quantity: 52,306. Distribution: US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI, NY, DC, SC, CT, NE, IA, WA, AR, NV, WV, AK, UT, ND, KS, CO, ME, MT, NM, SD, PR, WY, RI. OUS: PANAMA, CANADA, CHINA, TAIWAN, GERMANY, SLOVENIA, NORWAY, UNITED KINGDOM, ITALY, SPAIN, FINLAND, NETHERLANDS, SWEDEN, FRANCE, UNITED ARAB EMIRATES, DENMARK, PORTUGAL, AUSTRIA, SWITZERLAND, BELGIUM, TURKIYE, SLOVAK REPUBLIC, CYPRUS, SAUDI ARABIA, SOUTH AFRICA, LUXEMBOURG, FRENCH GUIANA, ANDORRA, IRELAND, NEW CALEDONIA, POLAND, ISRAEL, GREECE, GUADELOUPE, CROATIA, REUNION, BAHRAIN, HUNGARY, JAPAN
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Glenmark Pharmaceuticals Inc. recalled 13,824 tubes of Azelaic Acid Gel on September 17, 2025. The recall stems from market complaints regarding a gritty texture. Consumers should stop using the product immediately and contact their healthcare provider.