Flexima™ Biliary M00539230Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729162544), received between Aug 18, 2020 and Sep 29, 2026 — classified as 1 death, 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• DeathSep 29, 2026Difficult or Delayed Positioning; Difficult to Remove; Device-Device Incompatibility; Positioning Problem

  It was reported to Boston Scientific Corporation that a Flexima Biliary Preloaded Stent was to be implanted during a stent placement procedure performed on an unknown date. During the procedure, the guidewire ruptured inside the introducer, resulting in difficulty actuating and properly deploying the Flexima Biliary stent. The stent was deployed at an incorrect location and was not possible to be removed and additional measures were required to address the event. Another of the same device was used to complete the procedure.The patient the experienced hemodynamic instability, progressing to a drop in Hb, and the patient subsequently died.

  Patient problems: Insufficient Information

  MAUDE report 50936049 ↗
• MalfunctionJan 26, 2026Break; Retraction Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE COULD NOT BE PULLED OUT AND A FRACTURE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. 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 24183523 ↗
• InjuryMar 19, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE BILIARY TRACT TO TREAT A CHOLELITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE STENT BROKE INTO MULTIPLE PIECES AND WAS REMOVED USING FORCEPS. THERE WAS NO PART OF THE STENT THAT WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645575 ↗
• MalfunctionDec 11, 2024Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT GALLSTONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NORMAL IN SHAPE AND WAS DILATED BY 1 CM PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PUSH CATHETER WAS BROKEN INTO MORE THAN TWO PIECES, AND THE STENT DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE DELIVERY SYSTEM DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE FLEXIMA BILIARY STENT WITH DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "COMPLETELY RETRACT THE GUIDEWIRE INTO THE ENDOSCOPE. IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CAN NOT BE FULLY DEPLOYED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902437 ↗
• MalfunctionAug 12, 2024Break; Positioning Failure; Activation, Positioning or Separation Problem; Break; Positioning Failure; Activation, Positioning or Separation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-03894 AND 3005099803-2024-03895 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS USED IN THE BILE DUCT FOR STRICTURE MANAGEMENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY AS THE SUTURE WAS UNABLE TO BE RELEASED. A SECOND FLEXIMA BILIARY PRELOADED STENT OF A DIFFERENT SIZE WAS USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS CANCELLED DUE TO DEVICE AVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19969023 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED TO TREAT A CALCULUS OF THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING IMPLANTATION, THE INNER CORE OF THE DELIVERY SYSTEM WAS FRACTURED AND "IT COULD NOT BE USED NORMALLY". THE PROCEDURE WAS COMPLETED USING ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS 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 18013092 ↗
• MalfunctionApr 20, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH BILIARY BRUSH AND BILIARY STENT IMPLANTATION PROCEDURE IN THE HILAR BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE GUIDE CATHETER WAS KINKED. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 FINDING OF GUIDE CATHETER DETACHED/SEPARATED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14155439 ↗
• MalfunctionMar 2, 2022Break; Positioning Failure; Stretched; Activation, Positioning or Separation Problem; Break; Positioning Failure; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2021. DURING PROCEDURE, IT WAS NOTED THAT WHEN RELEASE WAS PERFORMED, THE FLEXIMA BILIARY STENT DID NOT SEPARATE FROM THE GUIDE CATHETER. IT WAS FOUND THAT THE GUIDE CATHETER BECAME STRETCHED. 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13651588 ↗
• MalfunctionMar 1, 2022Break; Positioning Failure; Stretched; Activation, Positioning or Separation Problem; Break; Positioning Failure; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2021. DURING PROCEDURE, IT WAS NOTED THAT WHEN RELEASE WAS PERFORMED, THE FLEXIMA BILIARY STENT DID NOT SEPARATE FROM THE GUIDE CATHETER. IT WAS FOUND THAT THE GUIDE CATHETER BECAME STRETCHED. 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13628237 ↗
• MalfunctionJan 10, 2022Break; Positioning Failure; Material Split, Cut or Torn; Break; Positioning Failure; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE TRACT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 FINDING OF GUIDE CATHETER BREAK. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203309 ↗
• MalfunctionJan 5, 2022Break; Positioning Failure; Deformation Due to Compressive Stress; Material Deformation; Break; Positioning Failure; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY STENT PLACEMENT PROCEDURE IN THE RIGHT HEPATICUS, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE NURSE INSERTED THE STENT INTO THE WORKING CHANNEL OF THE DUODENOSCOPE. THE OUTER ORANGE SLEEVE WAS PLACED TO HOLD THE STENTBARB DOWN FOR INSERTION. THE FLEXIMA WITH DELIVERY SYSTEM WAS ADVANCED THROUGH THE SCOPE CHANNEL USING SHORT STROKES UNTIL THE FLEXIMA WAS IN THE RIGHT POSITION. THE TUOHY-BORST ADAPTER WAS LOOSENED AND THE CATHETER AND THE GUIDEWIRE WERE PULLED BACK TO DELIVER THE FLEXIMA BUT THERE WAS RESISTANCE AND THE GUIDE CATHETER COILED AND THE STENT FAILED TO DEPLOY. ANOTHER STENT OF A DIFFERENT MODEL WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172887 ↗
• MalfunctionNov 30, 2021Break; Positioning Failure; Stretched; Deformation Due to Compressive Stress; Device-Device Incompatibility; Material Split, Cut or Torn; Break; Positioning Failure; Stretched; Deformation Due to Compressive Stress; Device-Device Incompatibility; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE LEFT HEPATICUS, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE NURSE INSERTED THE TAPERED TIP INTO THE WORKING CHANNEL OF THE DUODENOSCOPE AND THE OUTER ORANGE SLEEVE WAS PLACED TO HOLD THE STENTBARB DOWN FOR INSERTION. THE FLEXIMA DELIVERY SYSTEM WAS ADVANCED THROUGH THE SCOPE CHANNEL USING SHORT STROKES UNTIL THE FLEXIMA WAS IN THE RIGHT POSITION. THE TUOHY-BORST ADAPTER WAS LOOSEN AND THE CATHETER AND THE GUIDEWIRE WERE PULLED BACK TO DELIVER THE FLEXIMA. THE GUIDE CATHETER OCCURED LIKE A COIL AND THE STENT FAILED TO DEPLOY. ANOTHER STENT OF A DIFFERENT MODEL WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12900806 ↗
• InjuryFeb 16, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING WITHDRAWAL, AFTER THE PHYSICIAN SUCCESSFULLY DEPLOYED THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER STAYED OUT OF THE SCOPE AND DID NOT RETRACT WITH THE PUSH CATHETER. THE GUIDE CATHETER WAS FOUND TO BE BROKEN INTO TWO PIECES. THE BROKEN GUIDE CATHETER WAS PUSHED OUT OF THE SCOPE AND RETRIEVED WITH FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 11334292 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) IN THE BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN USED A FLEXIMA BILIARY STENT FOR DRAINANGE, HOWEVER, THE DELIVERY SHAFT MALFUNCTIONED, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS NOTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED/SEPARATED. THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522663 ↗
• MalfunctionAug 18, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE SCOPE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, RESISTANCE WAS FELT AND IT WAS DIFFICULT TO DEPLOY. AFTER A FEW ATTEMPTS, IT WAS NOTICED THAT THE GUIDE CATHETER BROKE. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 10421306 ↗