W.L. Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2)…
Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary…
Read the official notice →- Date
- 2024-02-28
- Country
- United States
- Brand
- W L Gore & Associates
- Product
- GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog…
- Classification
- Class II
- Units
- US Nationwide distribution in the state of Georgia.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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USW L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W,…
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FDA · DeviceW L Gore & Associates, Inc.US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI,…Official notice →- 2024-09-11
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W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A…
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FDA · DeviceW.L. Gore & Associates, Inc.US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.Official notice → - 2023-02-08
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Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could…
FDA · DeviceW L Gore & Associates, Inc.US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA,…Official notice → - 2022-11-02
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W L Gore & Associates, Inc. recalls GORE CARDIOFORM ASD Occluder. cardiovascular implant.
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W L Gore & Associates, Inc. recalls REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr,…
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