GORE VIABIL Biliary Endoprosthesis VSWVH1010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132638819), received between Aug 1, 2019 and Oct 1, 2024 — classified as 1 injury, 2 malfunctions.

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

4 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.

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.

• MalfunctionOct 1, 2024Fracture; Fracture

  IT WAS REPORTED TO GORE BY CONMED (CEN-74960), DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING THE GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS, DURING DEPLOYMENT OF A 10X10 VIABIL, THE STENT BEGAN TO "CANDY CANE" INSIDE OF THE BILE DUCT. THE "CANDY CANE" WAS FULLY DEPLOYED AND BROKE INTO THREE PIECES. THERE WAS A 2-HOUR DELAY IN THE PROCEDURE TO RETRIEVE THE PIECES. THERE WAS NO INDICATION OF PATIENT/USER IMPACT.

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 20347680 ↗
• MalfunctionJul 25, 2022Fracture; Off-Label Use; Fracture; Off-Label Use

  IT WAS REPORTED TO GORE BY (B)(6) THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING THE GORE® VIABIL® BILIARY ENDOPROSTHESIS, THE SURGEON WAS ATTEMPTING TO REMOVE A VIABIL STENT THAT WAS PLACED ON (B)(6) 2022. REPORTEDLY, THE STENT FELL APART AND ONLY HALF OF IT CAME OUT WHEN BEING REMOVED. IT WAS REPORTED THE SURGEON DECIDED TO KEEP HALF THE STENT (DISTAL END) WITHIN COMMON BILE DUCT DUE TO THE BILE STILL BEING ABLE TO FLOW FREELY. REPORTEDLY, THIS STENT INCLUDED THE CYSTIC DUCT DRAINAGE HOLES WHICH WAS LIKELY THE CAUSE OF EXCESS TISSUE INGROWTH WHICH RESULTED IN THE STENT BREAKING APART DURING REMOVAL. IT WAS REPORTED THE PATIENT WAS NOT HARMED AND NO SURGICAL INTERVENTION WAS NEEDED. REPORTEDLY, THERE ARE NO IMAGES AVAILABLE AND THE ANATOMICAL LOCATION OF THE DEVICE WAS THE COMMON BILE DUCT. IT WAS REPORTED A STANDARD CONMED FX WIRE .035 GUIDEWIRE AND DUODENOSCOPE WAS USED. REPORTEDLY, THIS STENT WAS ALREADY IN THE PATIENT TO TREAT A STRICTURE AND WAS BEING REMOVED. IT WAS REPORTED THE PHYSICIAN DID NOT RECALL ANY OUT THE ORDINARY MANIPULATION OF THE ENDOSCOPE OR CATHETER DURING THE CASE. REPORTEDLY, THE PHYSICIAN WAITED A FEW MINUTES AFTER ATT

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 15094555 ↗
• InjuryAug 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO GORE BY CONMED (CEN 5111) THAT A GORE® VIABIL® BILIARY ENDOPROSTHESIS WAS IMPLANTED IN A PATIENT DURING AN ERCP PROCEDURE. IT WAS REPORTED THE DEVICE MIGRATED EIGHT WEEKS LATER. IT WAS REPORTED THE STENT MOVED UP INTO THE DUCT AND WAS NO LONGER TRANSPAPILLARY. ADDITIONALLY, IT WAS REPORTED THE PATIENT WAS SEEN ON (B)(6) 2019 FOR STENT MANAGEMENT WHEN IT WAS OBSERVED THE STENT HAD MIGRATED APPROXIMATELY 5-7 MILLIMETERS PROXIMALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8853609 ↗

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
• 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