RX Biliary M00545650Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729252221), received between Feb 10, 2020 and Jul 24, 2022 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2022Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE NURSE ATTEMPTED TO DEPLOY THE STENT AND PULLED BACK THE GUIDE CATHETER, THE STENT DEPLOYED PREMATURELY AND THE GUIDE CATHETER BROKE. THE PHYSICIAN RETRIEVED BOTH THE STENT AND GUIDE CATHETER AT THE SAME TIME USING A SNARE AND DECIDED NOT TO PLACE ANOTHER STENT TO ADEQUATE THE BILE DRAINAGE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT AND SUCCESSFULLY 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 15090638 ↗
• MalfunctionFeb 10, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS USED IN A PROCEDURE, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THEY TRIED TO LOAD THE STENT ONTO THE DELIVERY SYSTEM, THE GUIDE CATHETER BECAME SEPARATED. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687411 ↗