Flexima™ Nasobiliary Catheter M00540120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729337386), received between Dec 20, 2016 and Sep 5, 2025 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA NASOBILIARY CATHETER WAS USED IN THE GALLBLADDER TO TREAT A COMMON BILE DUCT STONE DURING A PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE DEVICE RUPTURED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982248 ↗
• MalfunctionJul 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN FLEXIMA NASOBILIARY CATHTER WAS TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THERE WERE FOREIGN OBJECTS NOTED INSIDE THE INNER BAG (THE PART WHERE THE PACKAGE INSERT IS INSERTED). THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639867 ↗
• MalfunctionJul 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN FLEXIMA NASOBILIARY CATHTER WAS TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THERE WERE FOREIGN OBJECTS NOTED INSIDE THE INNER BAG (THE PART WHERE THE PACKAGE INSERT IS INSERTED). THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639866 ↗
• MalfunctionMar 20, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA NASOBILIARY CATHETER WAS OPENED FOR USED IN THE BILE DUCT FOR AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE CONNECTING PART OF DARK BLUE AND PALE BLUE TUBE IN THE WORKING LENGTH GOT SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA NASOBILIARY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6419221 ↗
• MalfunctionMar 9, 2017Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA¿ NASOBILIARY CATHETER WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) PLACEMENT PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHILE REMOVING THE WORKING LENGTH OF CATHETER FROM THE HOLDER, THE CATHETER GOT SEPARATED FROM THE JOINT OF THE RIGID PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6392973 ↗
• MalfunctionDec 20, 2016Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NASOBILIARY CATHETER WAS OPENED FOR USE DURING A ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE CATHETER GOT DETACHED WHEN REMOVED FROM THE POUCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER NASOBILIARY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT 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 6191294 ↗