Flexima™ Biliary M00539310Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729162629), received between Sep 14, 2019 and Sep 25, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED TO TREAT OBSTRUCTIVE JAUNDICE IN THE COMMON BILE DUCT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, SEVERE RESISTANCE WAS ENCOUNTERED AT THE MID BILE DUCT STENOSIS. THE DEVICE WAS REMOVED FOR BALLOON DILATATION, DURING WHICH A SNAPPING SOUND WAS HEARD. THE STENT AND DELIVERY SYSTEM COULD NOT BE RETRIEVED TOGETHER; THE DELIVERY SYSTEM WAS REMOVED FIRST, FOLLOWED BY THE STENT. THE INNER CATHETER APPEARED TO HAVE EXTENDED SEVERAL CENTIMETERS WITHOUT INTENTIONAL RELEASE. ANOTHER FLEXIMA BILIARY STENT 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 23145327 ↗
• MalfunctionMar 4, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS IMPLANTED DURING A BILE DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE DEVICE WAS PASSED OVER THE GUIDEWIRE AND REACHED THE PAPILLA, IT HAD ALREADY BEEN RELEASED. HOWEVER, THE SUTURE THREAD REMAINED ON THE STENT. ADDITIONALLY, THE FLAP ON THE HILAR SIDE HAD BEEN CUT (IT WAS NOT DISLODGED INSIDE THE PATIENT). THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MARCH 26, 2020. THE FLEXIMA BILIARY STENT WAS PLACED TO TREAT A STRICTURE IN THE COMMON BILE DUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520837 ↗
• MalfunctionJan 4, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRE-LOADED STENT WAS TO BE USED DURING A PROCEDURE ON AN UNKNOWN DATE. DURING PREPARATION, THE PACKAGING SEAL HAS PEELED OFF AND HAS STUCK TO ANOTHER PRODUCT UPON OPENING THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446494 ↗
• MalfunctionJun 9, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE PLACED IN THE DISTAL BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AFTER THE GUIDEWIRE WAS CORRECTLY POSITIONED, AN ATTEMPT WAS MADE TO CROSS THE STENOSIS, BUT DESPITE SEVERAL MANEUVERS, THE PHYSICIAN WAS UNABLE TO CROSS THE STENOSIS. AFTER SEVERAL ATTEMPTS, THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100632 ↗
• MalfunctionJan 12, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA PRELOADED BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING UNPACKING, THE PACKAGING WAS FOUND DAMAGED. THE STERILITY OF THE DEVICE WAS COMPROMISED. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY 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 13236872 ↗
• MalfunctionAug 26, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC BILIARY STENT PLACEMENT PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6)2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE STENT WAS RELEASED FOR DEPLOYMENT, THE GUIDE CATHETER BECAME SEPARATED FROM THE TOUHY BORST. HOWEVER, WHEN THE GUIDE CATHETER WAS REMOVED, THE STENT WAS DEPLOYED SUCCESSFULLY WITHOUT PROBLEM. REPORTEDLY, THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454804 ↗
• MalfunctionFeb 18, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE STENT WAS INSERTED INTO THE ENDOSCOPE DURING THE PROCEDURE, THE STENT DEPLOYED PREMATURELY. WHEN THE FLEXIMA BILIARY STENT WAS WITHDRAWN OUT FROM THE SCOPE, IT WAS NOTICED THAT THE GUIDE CATHETER WAS BROKEN AND THE STENT BARB WAS SEVERELY BENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720206 ↗
• MalfunctionNov 12, 2019Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ON (B)(6) 2019, THE FLEXIMA BILIARY STENT WAS IMPLANTED FOR CBD DILATION AND JAUNDICE. ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL ON (B)(6) 2019 FOR SPYGLASS PROCEDURE, THE PHYSICIAN DISCOVERED THAT THE STENT HAD MIGRATED OUT OF THE COMMON BILE DUCT. 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 FINE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON 22NOV2019 WHEN THE PHYSICIAN REACHED THE PAPILLA, THE STENT WAS GONE. THE PHYSICIAN THOUGHT THE STENT PASSED THROUGH THE PATIENT NATURALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311930 ↗
• MalfunctionSep 14, 2019Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2019-04575). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILIARY DUCT, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, THE SUTURE RELEASED PROPERLY BUT IT FAILED TO DEPLOY. THE DEVICE WAS NOTED TO BE 'DAMAGED'. CANNULATION WAS PERFORMED AND ANOTHER ATTEMPT WAS MADE USING A NEW FLEXIMA BILIARY STENT HOWEVER, THE SAME PROBLEM OCCURRED. FINALLY, A THIRD FLEXIMA BILIARY STENT WAS USED, YET THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING A FOURTH BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE PROXIMAL END OF THE GUIDE CATHETER WAS DETACHED WHILE THE REST OF THE GUIDE CATHETER APPEARED TO HAVE REMAINED WITHIN THE PUSH CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9056450 ↗