RX Biliary M00545580Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729337881), received between Nov 21, 2017 and Jul 24, 2022 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED THE STENT, THE GUIDE CATHETER DETACHED FROM THE DEPLOYMENT MECHANISM AND HAD TO BE RETRIEVED. THE STENT WAS DEPLOYED IN PLACE SUCCESSFULLY AND 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 15090654 ↗
• InjuryNov 15, 2021Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE STENT WAS INITIALLY DEPLOYED, IT WAS FOUND THAT THE GUIDE CATHETER APPROXIMATELY 4 INCHES LONG CAME BECAME DETACHED FROM THE GUIDEWIRE. IT WAS REPORTED THAT EXTRA SUPPLIES WERE NEEDED TO REMOVE THE DETACHED PIECE FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL FLEXIMA RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12809719 ↗
• MalfunctionDec 3, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX BILIARY STENT WAS USED IN THE COMMON BILE DUCT IN AN UNKNOWN PROCEDURE. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY ATTEMPTED TO RELEASE THE RX BILIARY STENT AT THE TARGET SITE, SEVERE RESISTANCE WAS ENCOUNTERED AND THE GUIDE CATHETER WAS UNABLE TO BE PULLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE GUIDE CATHETER BROKE, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125949 ↗
• InjuryNov 21, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE GUIDE CATHETER STRETCHED CAUSING DIFFICULTY IN RELEASING THE STENT AND LEADING TO THE DISTAL END OF THE GUIDE CATHETER BREAKING OFF FROM THE DEVICE. THE STENT AND BROKEN GUIDE CATHETER WERE REMOVED USING FORCEPS. ANOTHER FLEXIMA RX BILIARY STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT HEPATIC BILE DUCT. THE COMPLAINT DEVICE WAS REPOSITIONED AND IMPLANTED IN THE RIGHT HEPATIC BILE DUCT USING THE REMAINDER OF THE SECOND DELIVERY CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7049693 ↗