GORE VIABIL Biliary Endoprosthesis VN1006200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132615759), received between May 31, 2019 and May 31, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081184); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathMay 31, 2019Separation Failure; Material Deformation; Separation Failure; Material Deformation

  IT WAS REPORTED TO GORE BY CONMED, (CEN-2064) THAT DURING AN ERCP ON A MALE PATIENT ON (B)(6) 2019, THE PHYSICIAN PLACED A 10X6 GORE® VIABIL® BILIARY ENDOPROSTHESIS FOR DISTAL BILIARY STRICTURE. IT WAS REPORTED THAT UPON FULL DEPLOYMENT OF THE VIABIL, THE DELIVERY CATHETER COULD NOT BE WITHDRAWN BY THE PHYSICIAN. ACCORDING TO THE REPORT, AFTER WAITING A PERIOD OF TIME TO ALLOW FOR RELAXING, THE CATHETER COULD STILL NOT BE REMOVED, EVEN WITH A REPORTED STRONG REMOVAL FORCE. IT WAS REPORTED THE PHYSICIAN SUBSEQUENTLY CUT THE HUB END OF THE CATHETER OFF AT THE SCOPE PORT AND WENT BACK ALONG SIDE THE CATHETER AND PROCEEDED TO DILATE THE VIABIL SUCCESSFULLY WITH A 4MM DILATION BALLOON. REPORTEDLY, THE STENT WAS DRAINING, HOWEVER, THE CATHETER STILL COULD NOT BE REMOVED. ACCORDING TO THE REPORT, THE PHYSICIAN ATTEMPTED REMOVAL WITH A RAT TOOTH, PULLING WITH STRONG FORCE, HOWEVER HE WAS STILL NOT ABLE TO REMOVE THE STENT. REPORTEDLY, THE STENT WAS OBSERVED TO DEFORM A BIT AND A BEND WAS NOTED IN THE IMAGING, SHAPING THE STENT LIKE A U ABOUT THE MIDPOINT. IT WAS REPORTED THE PHYSICIAN ATTEMPTED APC AT 50 WATTS AND ENDOSCOPIC SCISSORS. REPORTEDLY, BOTH WERE UNSUCCESSFUL. IT WAS REPORTED THE

  Patient problems: Blood Loss; Death; Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 8660292 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081184. One submission often covers many models, so check the product and lot details in each record.

• Z-1593-2021 · Apr 5, 2021 · Terminated
  GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for pa