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Stents, Drains And Dilators For The Biliary Ducts
FDA product code FGE · Class 2 · Gastroenterology, Urology
0
Registered devices
34,031
Adverse events
453
Recalls
478
510(k) clearances
Devices with this code
Cotton-Leung — COOK IRELAND LTDIntraStent LD Max — Covidien LPCook — COOK INCORPORATEDAdvanix™ Pancreatic Stent — BOSTON SCIENTIFIC CORPORATIONAdvanix™ Pancreatic Stent — BOSTON SCIENTIFIC CORPORATIONVisi-Pro™ — Covidien LPGeenen — COOK IRELAND LTDHANAROSTENT® Biliary (NNN) — M.I.Tech Co., Ltd.Soehendra Tannenbaum — COOK IRELAND LTDGeenen — COOK IRELAND LTDSingle-use Balloon Dilatation Catheter — Leo Medical Co., Ltd.Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.S.M.A.R.T. — CORDIS CORPORATIONFreeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.Advanix™ Biliary — BOSTON SCIENTIFIC CORPORATIONMUSTANG™ — BOSTON SCIENTIFIC CORPORATIONAdvanix™ Pancreatic Stent — BOSTON SCIENTIFIC CORPORATIONLifeStar® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.Single Use Nasal Biliary Drainage Tube V — OLYMPUS MEDICAL SYSTEMS CORP.GORE VIABIL Biliary Endoprosthesis — W. L. Gore & Associates, Inc.LifeStent® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.Cotton-Leung Sof-Flex — COOK IRELAND LTDHobbs Biliary Amsterdam Stent — HOBBS MEDICAL, INC.SMART FLEX — Cordis US Corp.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-10 | Boston Scientific Corporation | Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this devic |
| 2026-09-03 | W L Gore & Associates, Inc. | The potential for the devices to be mislabeled with the incorrect length. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm, |
| 2026-05-22 | W L Gore & Associates, Inc. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes |
| 2026-05-22 | W L Gore & Associates, Inc. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
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