Flexima™ Nasobiliary Catheter M00540130Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729337393), received between Jul 14, 2021 and Sep 3, 2026 — classified as 2 injuries, 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 18, 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.

• InjurySep 3, 2026Leak/Splash; Material Split, Cut or Torn

  It was reported to Boston Scientific Corporation that a Flexima Nasobiliary Catheter was used for dilation of the intra and extrahepatic bile ducts with stone removal in the descending duodenum during an Endoscopic Retrograde Cholangiopancreatography (ERCP), Endoscopic Nasobiliary Drainage (ENBD), and biliary stent placement procedure performed on (b)(6) 2026. Following the procedure, the patient's jaundice worsened. Subsequent Computed tomography imaging demonstrated dislodgement of the ENBD drainage tube and prolapse of the biliary stent.On (b)(6) 2026, the patient underwent a repeat ERCP with ENBD placement and biliary stent replacement; however, no clinical improvement was observed. The originally placed nasobiliary drainage tube was removed using foreign body forceps. A follow-up CT scan performed on (b)(6) 2026, assessed the ENBD and biliary stent placement. Further CT imaging performed thereafter was reviewed with the Radiology Department, which confirmed that the drainage tube remained in situ, with the distal tip of the ENBD located in the lower common bile duct. On the same day, the attending physician performed a bedside saline flush of the ENBD tube and identified a cra

  Patient problems: Fever; Insufficient Information

  MAUDE report 50600072 ↗
• InjuryJun 25, 2026Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA NASOBILIARY CATHETER WAS INTENDED TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT JAUNDICE AND LOWER ABDOMINAL PAIN DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STONE REMOVAL PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TIP OF THE NASOBILIARY DRAINAGE CATHETER FRACTURED AFTER IT HAD BEEN INSERTED INTO THE PATIENT. THE FRACTURED SEGMENT REMAINED IN THE PATIENT'S COMMON BILE DUCT AND WAS DIFFICULT TO RETRIEVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25630754 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA NASOBILIARY CATHETER WAS USED IN THE DUODENAL PAPILLA TO TREAT COMMON BILE DUCT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE TIP WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED WHEREIN A TORN/SPLIT IS SHOWN AT THE TIP OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211218 ↗
• MalfunctionDec 10, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NASOBILIARY CATHETER WAS TO BE IMPLANTED TO TREAT A BILE DUCT TUMOR IN THE GALLSTONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH ENDOSCOPIC SPHINCTEROTOMY (EST) INVOLVING THE EXTRAHEPATIC BILE DUCT (EHBD) PROCEDURE PERFORMED ON (B)(6), 2025. DURING PREPARATION PRIOR TO PROCEDURE THE FRONT END WAS FRACTURED WHEN IT WAS UNPACKED. ANOTHER NASOBILIARY CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771629 ↗
• MalfunctionJul 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA NASOBILIARY CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE CALCULUS OF BILE DUCT PERFORMED ON (B)(6), 2021. DURING PREPARATION, IT WAS FOUND THAT THE PIG TAIL END WAS DETACHED AND COULD NOT BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA NASOBILIARY CATHETER. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165400 ↗