GORE VIABIL Biliary EndoprosthesisRecalls & reported problems across all models

We found 10 models of GORE VIABIL Biliary Endoprosthesis by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2019 and Sep 23, 2026 — classified as 1 death, 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GORE VIABIL Biliary Endoprosthesis recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 22, 2026Open, 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 ↗

2. May 22, 2026Open, 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-2914-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Jan 19, 2024Open, 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 · names 2 of these models · Recall details · FDA record ↗

Most reported GORE VIABIL Biliary Endoprosthesis problems

GORE VIABIL Biliary Endoprosthesis models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE VIABIL Biliary Endoprosthesis VSWVH1006

  Catheter, Biliary, Diagnostic
  1 recall3 reports
• GORE VIABIL Biliary Endoprosthesis VSWVH1008

  Catheter, Biliary, Diagnostic
  1 recall2 reports
• GORE VIABIL Biliary Endoprosthesis VSWVN1008

  Catheter, Biliary, Diagnostic
  1 recall2 reports
• GORE VIABIL Biliary Endoprosthesis VSWVN1010

  Catheter, Biliary, Diagnostic
  1 recall1 report
• GORE VIABIL Biliary Endoprosthesis VSWVH1010

  Catheter, Biliary, Diagnostic
  3 reports
• GORE VIABIL Biliary Endoprosthesis VSWVN1004

  Catheter, Biliary, Diagnostic
  3 reports
• GORE VIABIL Biliary Endoprosthesis VN0806200

  Catheter, Biliary, Diagnostic
  2 reports
• GORE VIABIL Biliary Endoprosthesis VH1008040

  Catheter, Biliary, Diagnostic
  1 report
• GORE VIABIL Biliary Endoprosthesis VN1006200

  Catheter, Biliary, Diagnostic
  1 death1 report
• GORE VIABIL Biliary Endoprosthesis VSWVN1006

  Catheter, Biliary, Diagnostic
  1 report

Recent GORE VIABIL Biliary Endoprosthesis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Obstruction of Flow; Migration

  Patient problems: Abdominal Pain; Obstruction/Occlusion

  MAUDE report 50872655 ↗
• 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 ↗
• InjuryMay 7, 2026Improper or Incorrect Procedure or Method; Wrong Label

  IT WAS REPORTED THAT A POTENTIAL MISLABELING INCIDENT MAY HAVE OCCURRED INVOLVING A GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS, INTENDED TO BE CATALOG NUMBER VSWVN1010 AND LABELED AS A 10 MM × 10 CM STENT. THE PROCEDURE ON (B)(6), 2026 WAS PERFORMED IN THE SETTING OF PRIOR BILIARY INTERVENTIONS. AT THE TIME OF THE PROCEDURE, A 10F × 9 CM PLASTIC BILIARY STENT (BOSTON SCIENTIFIC) AND AN EXISTING GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS MEASURING APPROXIMATELY 10 MM × 6 CM, WHICH HAD BEEN IMPLANTED APPROXIMATELY ONE TO TWO MONTHS PRIOR, WERE PRESENT IN THE BILE DUCT. THE EXISTING VIABIL STENT WAS REPORTED TO BE OCCLUDED. THE PROCEDURAL PLAN WAS TO REMOVE BOTH PREVIOUSLY IMPLANTED STENTS; HOWEVER, DUE TO ACCESS DIFFICULTY, THE PLASTIC STENT WAS REMOVED AND THE EXISTING VIABIL STENT WAS RELINED TO ADDRESS THE OCCLUSION BY PLACING A NEW VIABIL STENT THROUGH IT. DURING ADVANCEMENT AND DEPLOYMENT OF THE NEW VIABIL STENT ON (B)(6), 2026, THE DEVICE APPEARED SHORTER THAN EXPECTED UPON VISUAL INSPECTION. THIS CONCERN WAS RAISED INTRA-PROCEDURALLY BY AN EXPERIENCED ENDOSCOPY TECHNICIAN AND CONFIRMED BY THE IMPLANTING PHYSICIAN. REVIEW OF THE DEVICE PACKAGING DURING THE CASE INDICA

  Patient problems: Biliary Leak

  MAUDE report 25117235 ↗
• MalfunctionJan 30, 2025

  STENT WAS INSERTED INTO SCOPE AND WOULD NOT DEPLOY. THERE IS A SPACE AT THE TIP OF DEPLOYER AND SHEATH WHICH MAY BE THE CAUSE OF THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272682 ↗
• 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 ↗
• MalfunctionApr 30, 2024

  STENT PARTIALLY DEPLOYED DURING OPENING, UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213094 ↗
• MalfunctionApr 30, 2024

  ATTEMPTED TO DEPLOY STENT, PULLED STRING BUT STENT DID NOT DEPLOY OR OPEN AT ALL. COULD NOT USE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213030 ↗
• MalfunctionApr 16, 2024

  THE STENT WOULD NOT DEPLOY CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115030 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other W. L. Gore & Associates, Inc. products

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• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
• GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports