GORE VIABIL Biliary Endoprosthesis VSWVH1008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132638802), received between Aug 19, 2022 and Jul 17, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryJul 17, 2026Material Fragmentation

  IT WAS REPORTED BY OLYMPUS THAT A GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS WAS SELECTED FOR USE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. DURING WITHDRAWAL OF THE DEVICE, MATERIAL DAMAGE DESCRIBED AS SHREDDING WAS OBSERVED. FOLLOWING THE EVENT, THE PATIENT EXPERIENCED BLEEDING REQUIRING INTUBATION AND TRANSFER TO THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION REGARDING THE PROCEDURE, REASON FOR DEVICE REMOVAL, DEVICE CONDITION, TREATMENT OF THE BLEEDING, AND PATIENT OUTCOME WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25861058 ↗
• MalfunctionAug 19, 2022Fracture; Off-Label Use; Material Puncture/Hole; Difficult to Remove; Unraveled Material; Fracture; Off-Label Use; Material Puncture/Hole; Difficult to Remove; 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, THE DEVICE UNRAVELED UPON REMOVAL ATTEMPT. REPORTEDLY, ALL PIECES WERE REMOVED AND NO PAIN WAS CAUSED TO THE PATIENT. IT WAS REPORTED THE DEVICE WAS DISCARDED AT THE FACILITY AND THIS WAS FOUND DURING THE PROCEDURE. REPORTEDLY, THE PROCEDURE BEING PERFORMED WAS A STENT REMOVAL FOR AN UNKNOWN REASON. IT WAS REPORTED AND CONFIRMED THE STENT UNRAVELED AND THERE WAS BREAKAGE, RESULTING IN A STENT WIRE FRACTURE. REPORTEDLY, THE ANATOMICAL LOCATION OF THE DEVICE WHEN IT WOULD NOT DEPLOY IS UNKNOWN, IT WAS REPORTED THE LENGTH, DIAMETER AND STIFFNESS OF THE GUIDEWIRE IS UNKNOWN.

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 15260208 ↗

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-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
• 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