GORE VIABIL Biliary Endoprosthesis VSWVN1008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132638871), received between Feb 24, 2022 and Dec 14, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K170740); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 19, 2024Class IIOpen, Classified

   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 procedure, cholangitis, cholecystitis, and/or pain. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.

   Z-1179-2024 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO GORE BY CONMED (CEN-65010) THAT DURING A REPEAT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, DUE TO INCREASED LFTS USING THE GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS, REPORTEDLY, THE STENT WAS OCCLUDED. THE PLAN WAS TO PERFORM A STENT EXCHANGE, IT WAS REPORTED THAT PARTS OF THE STENT DISINTEGRATED DURING REMOVAL, AND SMALL PIECES WERE REMOVED. THERE WAS REPORTEDLY A 30 MINUTE DELAY OF PROCEDURE. ANOTHER GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS IS UNKNOWN AT THIS TIME. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18332050 ↗
• MalfunctionFeb 24, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED TO GORE BY CONMED ((B)(4)) THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING THE GORE® VIABIL® BILIARY ENDOPROSTHESIS, DR.(B)(6) HAD PLACED A VIABIL®. HE PROCEEDED TO REMOVE THE VIABIL® (OFF LABEL) AND IT BEGAN TO UNRAVEL. IT WAS LODGED INTO THE BILE DUCT. THE SALES REP SPOKE WITH (B)(6) WHO IS THE LEAD ADMIN AT U OF C AND ALSO SPOKE WITH DR. (B)(6) ON THE PHONE OFFERING HELP. A MONTH LATER DR. (B)(6) WAS ABLE TO REMOVE THE VIABIL® FROM THE PATIENT WITH NO OTHER ISSUES. THERE WAS NO IMPACT TO THE PATIENT. A HISTOLOGY KIT HAS BEEN ORDERED FOR THE RETURN OF THE EXPLANTED DEVICE.

  Patient problems: Stenosis; Swelling/ Edema

  MAUDE report 13591856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170740. One submission often covers many models, so check the product and lot details in each record.

• Z-0158-2027 · Sep 3, 2026 · Open, Classified
  Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis
• Z-2915-2026 · May 22, 2026 · Open, Classified
  GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may b
• Z-2914-2026 · May 22, 2026 · Open, Classified
  GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may b