Flexima™ Biliary M00539200Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729337362), received between May 2, 2017 and Jun 2, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Break; Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS TO BE IMPLANTED TO TREAT BILIARY STENOSIS IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON APRIL 03, 2026. DURING THE PROCEDURE, WHEN THE STENT PUSHER WAS PULLED, THE CONNECTING WIRE FRACTURED AND THE STENT COULD NOT BE DEPLOYED. FURTHER INFORMATION RECEIVED CONFIRMED THE DAMAGE WAS NOT DUE TO A SUTURE BREAK BUT RATHER AT THE CONNECTION POINT BETWEEN THE DELIVERY SYSTEM AND THE STENT STRUCTURE. ANOTHER FLEXIMA BILIARY PRELOADED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE INSTRUCTIONS FOR USE (IFU): "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." THE USER DID NOT FOLLOW THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361657 ↗
• MalfunctionApr 16, 2026Break; 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 ATTEMPTED TO BE IMPLANTED INTO THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE INSTRUCTIONS FOR USE (IFU): IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED. THE USER DID NOT FOLLOW THE IFU. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901375 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED IN THE BILIARY TRACT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT DELIVERY DEVICE WAS PULLED, AND IT WAS NOTICED THE CONNECTING WIRE WAS FRACTURED. THE STENT COULD NOT BE DEPLOYED, AND THE PROCEDURE HAD TO BE COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885679 ↗
• MalfunctionApr 4, 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 PRELOADED STENT WAS TO BE USED TO TREAT BILE DUCT OBSTRUCTION SECONDARY TO BILIARY STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION AND OUTSIDE THE PATIENT, IT WAS FOUND THAT THE PUSH CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT WHICH REVEALED THE CATHETER GUIDE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778581 ↗
• MalfunctionNov 1, 2024Break; Positioning Failure; Use of Device Problem; Break; Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS TO BE IMPLANTED TO TREAT A BILE DUCT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE FRONT END OF THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY PRELOADED 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. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS INSIDE THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE IFU, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED." THE PHYSICIAN DID NOT FOLLOW THE DEPLOYMENT STEPS. THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULTS, WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588829 ↗
• MalfunctionJul 1, 2024Positioning Failure; Material Deformation; Material Split, Cut or Torn; Positioning Failure; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE USED TO TREAT MULTIPLE STONES IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS BENT AND COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE STENT BARB WAS TORN. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652155 ↗
• MalfunctionJan 11, 2022Break; Positioning Failure; Material Deformation; Material Split, Cut or Torn; Break; Positioning Failure; Material Deformation; 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 DUCT, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225207 ↗
• MalfunctionJan 10, 2022Break; Positioning Failure; Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; Material Split, Cut or Torn; Break; Positioning Failure; Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2021 FOR THE TREATMENT OF SECONDARY SCLEROTIC CHOLANGITIS. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE FLEXIMA STENT FAILED TO DEPLOY. THE GUIDEWIRE WAS COMPLETELY REMOVED FOR DEPLOYMENT, BUT THE SUTURE DID NOT PEEL AWAY, PREVENTING STENT DEPLOYMENT. A SECOND FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE USED, BUT THE SAME ISSUE OCCURRED. A THIRD FLEXIMA BILIARY STENT DEVICE WAS SUCCESSFULLY USED TO COMPLETE 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 13206293 ↗
• MalfunctionJan 10, 2022Break; Positioning Failure; Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; Material Split, Cut or Torn; Break; Positioning Failure; Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; 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 COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE SUTURE WAS STUCK PREVENTING THE STENT TO BE DEPLOYED. ANOTHER FLEXIMA BILIARY STENT WAS ATTEMPTED TO USE BUT THE SAME PROBLEM WAS NOTICED. A THIRD FLEXIMA BILIARY STENT 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 13203181 ↗
• InjuryOct 25, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDE CATHETER WAS BROKEN INTO TWO PIECES AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH A RETRIEVAL DEVICE. THERE WAS NO INFORMATION PROVIDED REGARDING THE PROCEDURE OUTCOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688760 ↗
• MalfunctionOct 25, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT PLACEMENT PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE GUIDE CATHETER WAS BROKEN. IT WAS UNKNOWN HOW THE BROKEN PIECE OF GUIDE CATHETER WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BUT IT WAS UNKNOWN WHAT DEVICE COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12687988 ↗
• MalfunctionMar 13, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE SUTURE DID NOT RELEASE AND THE STENT FAILED TO DEPLOY. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; GUIDE CATHETER BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831489 ↗
• InjuryMay 2, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA¿ BILIARY STENT WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN COMMON BILE DUCT ON (B)(6) 2017 ACCORDING TO THE COMPLAINANT, DURING ATTEMPTED DEPLOYMENT OF THE FLEXIMA¿ BILIARY STENT, THE GUIDE CATHETER STRETCHED AND BROKE. THIS EVENT REPORTEDLY REQUIRED INTERVENTION TO REMOVE THE BROKEN DEVICE, HOWEVER, NO FURTHER INFORMATION COULD BE OBTAINED AT THIS TIME. AFTER MANIPULATION OF THE DEVICE, THE STENT WAS SUCCESSFULLY DEPLOYED AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THIS EVENT DID NOT RESULT IN ANY COMPLICATION OR HARM TO THE PATIENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6536754 ↗