Flexima™ Biliary M00539240Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729162551), received between Jan 17, 2017 and Jan 9, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionJan 9, 2026Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS TO BE IMPLANTED FOR DRAINAGE (MODERATE STENOSIS) IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT COULD NOT BE DEPLOYED WHEN PLACING THE STENT FOR DRAINAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CATHETER GUIDE DETACHED OR SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24025545 ↗
• MalfunctionSep 4, 2024Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED IN THE COMMON BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S 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 GUIDE CATHETER BROKE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135062 ↗
• MalfunctionApr 9, 2024Break; Positioning Failure; Use of Device Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Deformation Due to Compressive Stress; 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 IN THE HEPATOPORTAL BILE DUCTS TO TREAT A HEPATIC PORTAL BILE DUCT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), BILE DUCT BRUSHING, AND BILIARY STENTING PROCEDURES PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE INNER GUIDE CATHETER OF THE DELIVERY SYSTEM WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075631 ↗
• MalfunctionJan 26, 2024Break; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Material Deformation; 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 STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE GUIDE CATHETER WAS NOTED TO BE BROKEN WHEN THE DEVICE WAS UNPACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587391 ↗
• MalfunctionOct 23, 2019Break; 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) 2018. ACCORDING TO THE COMPLAINANT, WHEN DELIVERING THE STENT INTO THE PATIENT, THE GUIDE CATHETER WAS PULLED OUT THE PUSH CATHETER TO DEPLOY THE STENT, HOWEVER, THE SUTURE DIDN'T RELEASE AND THE GUIDE CATHETER BROKE. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ENABLING THE ENTIRE DEVICE TO BE REMOVED FROM THE PATIENT IN ONE PIECE. NO OTHER ISSUES WERE NOTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 VERY GOOD.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9226057 ↗
• MalfunctionJan 17, 2017Device Packaging Compromised; Device Packaging Compromised

  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 UNPACKING, IT WAS OBSERVED THAT THE STERILE SEAL OF THE DEVICE WAS DAMAGED AND HAS AN AIR LEAKAGE. THE PROCEDURE WAS 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 Consequences Or Impact To Patient

  MAUDE report 6258034 ↗