Flexima™ Biliary M00539300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729162612), received between Mar 4, 2021 and Dec 1, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionDec 1, 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 TO TREAT A COMMON BILE DUCT STONES IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT HAD SEPARATED AT THE PIGTAIL (PROXIMAL SIDE) FLAP. 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 23686982 ↗
• MalfunctionOct 24, 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 IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE INNER CATHETER BROKE, BUT NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF A DIFFERENT MODEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 9, 10, AND 20, 2025: IT WAS LATER CONFIRMED THAT THE STENT WAS TO BE IMPLANTED IN THE PORTA HEPATIS (HILUM OF THE LIVER) TO ACHIEVE BILIARY DRAINAGE AT THE HILUM AND TREAT A SEVERE STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN OCTOBER 2025. THE SPECIFIC DATE IS UNKNOWN. IT WAS FURTHER REPORTED THAT THE BROKEN INNER CATHETER REMAINED WITHIN THE PUSH CATHETER DURING REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380683 ↗
• InjuryMar 4, 2021Difficult to Remove; Migration; Difficult to Remove; Migration

  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) 2020. IT WAS REPORTED THAT, A ROUTINE FOLLOW UP FOR STENT REMOVAL WAS PERFORMED ON (B)(6) 2021. IT WAS NOTED THAT THE FLEXIMA STENT MIGRATED PROXIMAL INTO THE BILE DUCT. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT WITH AN EXTRACTION BALLOON, BUT WITHOUT SUCCESS. A 10FR X 5CM AND 7FR X 5CM DOUBLE PIGTAIL STENTS WERE IMPLANTED. THE PROCEDURE TO REMOVE THE MIGRATED STENT ENDOSCOPICALLY WAS RESCHEDULED. IT WAS REPORTED THAT THE MIGRATED STENT WAS SUCCESSFULLY REMOVED ON (B)(6) 2021. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408984 ↗