Flexima™ Biliary M00539320Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729162636), received between Jan 17, 2017 and May 14, 2026 — classified as 6 malfunctions.

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

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED FOR DILATATION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT WAS IMPLANTED; HOWEVER, FOLLOWING PLACEMENT, IT WAS NOTED THAT THE RADIOPAQUE MARKER BAND HAD DETACHED AND REMAINED INSIDE THE PATIENT. THE MARKER BAND WAS LEFT IN SITU, AS THE PHYSICIAN DETERMINED THAT IT WOULD NOT IMPACT THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL STENT, AND NO ADDITIONAL SURGERY OR INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25167982 ↗
• MalfunctionMar 24, 2025Break; Positioning Failure; Entrapment of Device; Stretched; Break; Positioning Failure; Entrapment of Device; Stretched

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FLEXIMA BILIARY STENT DID NOT DEPLOY. THE DUODENOSCOPE WAS THEN REMOVED BECAUSE THE STENT CATHETER GOT STUCK IN THE WORKING CHANNEL. THE DELIVERY SYSTEM WAS CHECKED, AND IT WAS OBSERVED THAT THE GRAY STENT DELIVERY TUBE WAS NOTED TO BE STUCK AND STRETCHED, AND THE STENT ITSELF WAS NOTED TO BE DAMAGED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681885 ↗
• MalfunctionFeb 1, 2022Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED BOSTON SCIENTIFIC CORPORATION THAT AN FLEXIMA BILIARY STENT WAS OPENED TO BE USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH PLASTIC STENT PLACEMENT IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING UNPACKING, IT WAS FOUND THAT THE FLEXIMA BILIARY STENT HAS BEEN DEPLOYED IN THE PACKAGING. ADDITIONALLY, IT WAS NOTED THAT THE FLEXIMA BILIARY STENT WAS DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE AS NO PATIENT COMPLICATIONS. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418864 ↗
• MalfunctionFeb 24, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2021 IT WAS REPORTED THAT, WHEN THE PHYSICIAN OPENED THE PACKAGE, THE STENT WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376374 ↗
• MalfunctionAug 5, 2019Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2019-03911 AND MFR. REPORT # 3005099803-2019-03910). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PREVIOUSLY IMPLANTED FLEXIMA BILIARY STENTS WERE REMOVED FROM A PATIENT DURING AN ENDOSCOPIC BILIARY DRAINAGE WITH STENT EXCHANGE PROCEDURE PERFORMED ON (B)(6) 2019. THE EXACT IMPLANT DATES FOR THE FLEXIMA STENTS WERE NOT REPORTED. THE PATIENT HAD A PREVIOUSLY PLACED A FLEXIMA BILIARY STENT 10FR/10CM IN B6, AND A FLEXIMA BILIARY STENT 10FR/15CM IN B8. BOTH STENTS WERE REPORTED TO BE OCCLUDED. THE PHYSICIAN REMOVED THE OCCLUDED STENTS USING A SNARE. THE PHYSICIAN ATTEMPTED TO PLACE A NEW FLEXIMA BILIARY STENT 10FR/15CM IN B8, HOWEVER THE DEVICE BECAME DIFFICULT TO ADVANCE IN THE PATIENT'S ANATOMY DUE TO SEVERE TORTUOSITY. THE DEVICE WAS PULLED OUT TO CHANGE THE GUIDEWIRE. THE GUIDEWIRE WAS REPLACED AND THE PHYSICIAN ATTEMPTED AGAIN TO PLACE THE FLEXIMA BILIARY STENT 10FR/15CM IN B8 HOWEVER THE STENT PREMATURELY DEPLOYED FROM THE DELIVERY SYSTEM. UPON REMOVAL AND EXAMINATION OF THE FLEXIMA BILIARY STENT 10FR/15CM, THE SUTURE WAS NOTED TO BE SEPARATED AND REMAINED INSIDE THE WOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8862167 ↗
• MalfunctionJan 17, 2017Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA¿ BILIARY STENT WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS SEPARATED FROM THE DELIVERY SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE". THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6255788 ↗