Flexima™ Biliary M00539340Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729162650), received between Aug 5, 2019 and Jul 27, 2026 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50003650 ↗
• MalfunctionMay 27, 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 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SPECIALIST INSERTED THE DEVICE; HOWEVER, WHEN ATTEMPTING TO RELEASE THE STENT, IT WAS NOT POSSIBLE TO DEPLOY. 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: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25308386 ↗
• InjuryNov 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 9336490 ↗
• MalfunctionAug 5, 2019Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2019-03911 AND 3005099803-2019-03910). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PREVIOUSLY IMPLANTED FLEXIMA BILIARY STENTS WERE REMOVED FROM A PATIENT DURING AN ENDOSCOPIC BILIARY DRAINAGE WITH STENT EXCHANGE PROCEDURE PERFORMED ON (B)(6) 2019. THE EXACT IMPLANT DATES FOR THE FLEXIMA STENTS WERE NOT REPORTED. THE PATIENT HAD A PREVIOUSLY PLACED A FLEXIMA BILIARY STENT 10FR/10CM IN B6, AND A FLEXIMA BILIARY STENT 10FR/15CM IN B8. BOTH STENTS WERE REPORTED TO BE OCCLUDED. THE PHYSICIAN REMOVED THE OCCLUDED STENTS USING A SNARE. THE PHYSICIAN ATTEMPTED TO PLACE A NEW FLEXIMA BILIARY STENT 10FR/15CM IN B8, HOWEVER THE DEVICE BECAME DIFFICULT TO ADVANCE IN THE PATIENT'S ANATOMY DUE TO SEVERE TORTUOSITY. THE DEVICE WAS PULLED OUT TO CHANGE THE GUIDEWIRE. THE GUIDEWIRE WAS REPLACED AND THE PHYSICIAN ATTEMPTED AGAIN TO PLACE THE FLEXIMA BILIARY STENT 10FR/15CM IN B8 HOWEVER THE STENT PREMATURELY DEPLOYED FROM THE DELIVERY SYSTEM. UPON REMOVAL AND EXAMINATION OF THE FLEXIMA BILIARY STENT 10FR/15CM, THE SUTURE WAS NOTED TO BE SEPARATED AND REMAINED INSIDE THE WORKING CHANNEL O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8862299 ↗