RX Biliary M00545670Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729301844), received between Oct 24, 2017 and Feb 8, 2022 — classified as 3 injuries, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2022Break; Material Deformation; Break; Material Deformation

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDE CATHETER WAS BROKEN. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE PUSH CATHETER WAS KINKED. THERE WERE NO PATIENT COMPLICATIONS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13479107 ↗
• MalfunctionJul 9, 2021Break; Positioning Failure; Retraction Problem; Break; Positioning Failure; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC BALLOON DILATION (EBD) POSITIONING PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2021. DURING PROCEDURE, IT WAS NOTED THAT A RESISTANCE WAS FELT WHEN THE DEVICE WAS POSITIONED. THE GUIDE CATHETER BECAME BROKEN INSIDE THE PATIENT, HOWEVER IT WAS SUCCESSFULLY REMOVED USING A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA RX 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 AS "NO PATIENT INJURY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142988 ↗
• InjuryJun 9, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH SPHINCTEROTOMY, AND BALLOON SWEEP WITH REMOVAL OF STONE AND STENT PLACEMENT PROCEDURE, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, A LARGE STONE IN THE DISTAL DUCT WAS IDENTIFIED BUT COULD NOT BE REMOVED. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT IT WAS NOTICED THAT A SMALL PORTION OF THE STENT WAS BROKEN. THE BROKEN PORTION OF THE STENT WAS RETRIEVED WITH A HYDROTOME AND ANOTHER FLEXIMA RX STENT OF A DIFFERENT SIZE SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11967675 ↗
• InjuryAug 21, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED IN A TUBE STENT PLACEMENT PERFORMED IN BILE DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY DEPLOY THE STENT, THE GUIDE CATHETER DETACH FROM THE DELIVERY SYSTEM AND REMAINED WITHIN THE STENT INSIDE THE PATIENT. THE STENT AND THE DETACHED GUIDE CATHETER WERE RETRIEVED USING FORCEPS. ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801267 ↗
• InjuryOct 24, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FLEXIMA RX BILIARY STENT WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, UPON DEPLOYING THE STENT, THE CLEAR GUIDE CATHETER FELL OFF AND STAYED INSIDE THE PATIENT. HOWEVER, THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN PIECE OF GUIDE CATHETER AND THE PROCEDURE WAS COMPLETED WITH THIS 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 "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6970890 ↗