GORE VIABIL Biliary Endoprosthesis VSWVH1006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132638796), received between Aug 23, 2021 and Jan 3, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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. May 22, 2026Class IIOpen, Classified

   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 (VSWVN1010).

   Z-2915-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO GORE BY CONMED ((B)(6)) THAT DURING AN UNKNOWN PROCEDURE USING THE GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS, THE STENT BROKE INTO PIECES AND ALL PIECES WERE EVENTUALLY REMOVED. THE DEVICE IS NOT AVAILABLE FOR RETURN. THERE IS NO INDICATION OF PATIENT IMPACT. IT WAS FURTHER REPORTED THIS CASE WAS A PLANNED REMOVAL. THE DEVICE WAS PLACED IN THE COMMON BILE DUCT ON (B)(6), 2023. THERE WAS NO OUT OF THE ORDINARY MANIPULATION OF THE ENDOSCOPE OR CATHETER DURING THE REMOVAL. A DUODENOSCOPE WAS USED AND THE INITIAL ATTEMPT WAS WITH A SNARE, WHICH IS WHEN THE STENT FRACTURED. MULTIPLE ATTEMPTS WITH THE SNARE AND RAPTOR GRASPER WERE MADE. THE DEVICE WAS DISCARDED AFTER THE CASE.

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 18440598 ↗
• MalfunctionAug 19, 2022Break; Fracture; Off-Label Use; Material Puncture/Hole; Difficult to Remove; Unraveled Material; Fracture; Off-Label Use; Material Puncture/Hole; Difficult to Remove

  IT WAS REPORTED TO GORE BY CONMED (CEN-49927) 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: No Clinical Signs, Symptoms or Conditions; Unspecified Hepatic or Biliary Problem

  MAUDE report 15259791 ↗
• InjuryAug 23, 2021Unraveled Material; Unraveled Material

  IT WAS REPORTED TO GORE BY CONMED ((B)(4)) THAT DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY). THE GORE¿ VIABIL¿ BILIARY ENDOPROSTHESIS DISTAL 4 CM, UNRAVELED ON REMOVAL. REPORTEDLY THE REMAINING PROXIMAL 2 CM STENT IS EMBEDDED INTO THE TISSUE AND WAS NOT ABLE TO BE REMOVED. IT WAS REPORTED THAT THE PROXIMAL 2 CM OF STENT REMAINS IN THE DUCT. REPORTEDLY THERE WAS A 7 HOUR DELAY IN THE PROCEDURE. REPORTEDLY A PLASTIC STENT WAS PLACED TO KEEP THE DUCT PATENT. IT WAS REPORTED THAT A REMOVAL PROCEDURE WAS SCHEDULED FOR (B)(6) 2021. REPORTEDLY THE PATIENT WENT HOME.

  Patient problems: Biliary Cirrhosis

  MAUDE report 12357120 ↗

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-1179-2024 · Jan 19, 2024 · Open, Classified
  GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes