Flexxus® Endoscopic Biliary Stent LXB10080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741099298), received between Jul 23, 2018 and Dec 28, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K031186); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DEPLOYED PREMATURELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13096751 ↗
• MalfunctionJun 30, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DEPLOYED PREMATURELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091053 ↗
• MalfunctionSep 26, 2018Premature Activation; Misfire; Premature Activation; Misfire

  IT WAS REPORTED THAT DURING DEPLOYMENT OF STENT, STENT ALLEGEDLY PARTIALLY DEPLOYED. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7909861 ↗
• MalfunctionAug 20, 2018Fracture; Malposition of Device; Fracture; Malposition of Device

  IT WAS REPORTED THAT A 10X80MM STENT WAS POSITIONED TOO HIGH DURING AN (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY), SO PHYSICIAN TRIED TO RELOCATE THE STENT WITH A SNARE, WHICH RESULTED IN FRACTURE OF THE STENT. THE PHYSICIAN USED A FORCEPS FOR ANOTHER ATTEMPT TO RELOCATE THE STENT BUT THE STENT CONTINUED TO FRACTURE. REPORTEDLY NOT ALL OF THE STENT SEGMENTS WERE ABLE TO BE REMOVED FROM THE PATIENT; SOME OF THE FRACTURED PIECES REMAINED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799801 ↗
• MalfunctionJul 23, 2018Break; Migration or Expulsion of Device

  FLEXXUS ENDOSCOPIC BILIARY STENT PLACED IN COMMON BILE DUCT BY DOCTOR USING PROPER TECHNIQUE. STENT PULLED DOWN WITH RAT TOOTH FORCEPS AND UNEXPECTEDLY CAME APART IN PIECES. WE GRASPED THE DUODENAL END OF STENT AND ATTEMPTED TO TAKE OUT THE STENT WITH RAT TOOTH FORCEPS AND SNARE BUT THE END OF THE STENT FELL APART AND SO WE ENDED UP TRIMMING THE STENT TO THE LEVEL OF THE PAPILLA. WE USED A RETRIEVAL BALLOON TO OBTAIN A CHOLANGIOGRAM AND ALL DUCTS APPEARED TO FILL WITH CONTRAST, INDICATING PATENCY. FINAL FLUOROSCOPIC VIEWS OF THE HEMIDIAPHRAGM REVEALED NO FREE AIR. THE DUODENOSCOPE WAS THEN COMPLETELY WITHDRAWN, INSUFFLATED AIR WAS ASPIRATED, AND THE PATIENT WAS EXTUBATED AND RETURNED TO THE RECOVERY AREA IN GOOD CONDITION HAVING TOLERATED THE PROCEDURE WELL. THE MAJORITY OF THE STENT REMAINS IN PATIENT. THE PIECES AND ORIGINAL PACKAGING WERE SAVED AND WILL BE GIVEN TO COMPANY REPRESENTATIVE. NO IMMEDIATE POST PROCEDURE COMPLICATIONS WERE OBSERVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7709835 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031186. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2007 · Mar 14, 2007 · Terminated
  Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length Item Number: LXB10060
• Z-0729-2007 · Mar 14, 2007 · Terminated
  Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number: LXB10040
• Z-1577-05 · Jul 28, 2005 · Terminated
  Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 60 mm Catalog Number: LXB08060