Flexima™ Biliary M00539330Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729162643), received between Nov 18, 2019 and Jul 8, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 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 COMMON BILE DUCT DURING AN ENDOSCOPIC BILIARY DRAINAGE (EBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CONNECTOR AT THE PROXIMAL PART OF THE INNER SHEATH BECAME DISCONNECTED. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ALLOWING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436718 ↗
• MalfunctionMay 26, 2022Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A BILIARY DRAINAGE PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2022. DURING THE PREPARATION, WHEN THE DEVICE WAS UNPACKED, IT WAS FOUND THAT THE DELIVERY SYSTEM WAS NOT CONNECTED TO THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515605 ↗
• MalfunctionNov 18, 2019Break; Break

  NOTE: THIS REPORT IS ONE OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2019-05601, 3005099803-2019-05622 AND 3005099803-2019-05625). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE FLEXIMA BILIARY STENTS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHILE DEPLOYING THE FLEXIMA BILIARY STENT INSIDE THE PATIENT, THE GUIDE CATHETER STRETCHED. THE STENT WAS IMPLANTED IN THE PATIENT. A PHOTO OF THE DEVICE AFTER BEING REMOVED FROM THE PATIENT SHOWS THE GUIDE CATHETER WAS BROKEN. A SECOND FLEXIMA BILIARY STENT WAS BEING PLACED, BUT THE GUIDE CATHETER BROKE DURING ATTEMPTED DEPLOYMENT. THE STENT WAS IMPLANTED IN THE PATIENT. THE GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ENABLING THE CATHETER TO BE REMOVED FROM THE PATIENT IN ONE PIECE. A THIRD FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE PLACED, BUT THE GUIDE CATHETER BROKE OFF DURING ATTEMPTED DEPLOYMENT AND REMAINED WITHIN THE STENT. THE BROKEN GUIDE CATHETER AND STENT WERE REMOVED BY THE PHYSICIAN USING BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9336491 ↗