Contour ERCP Cannula M00530860Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729099819), received between Apr 27, 2022 and Jan 5, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 5, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR ERCP CANNULA WAS BEING PREPARED FOR USE IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTICED THAT THERE WAS A DAMAGE ON THE PACKAGING OF THE DEVICE, AND "THE PACKAGE WAS NOT SEALED SOMEHOW." THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449848 ↗
• MalfunctionJan 5, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR ERCP CANNULA WAS BEING PREPARED FOR USE IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTICED THAT THERE WAS A DAMAGE ON THE PACKAGING OF THE DEVICE, AND "THE PACKAGE WAS NOT SEALED SOMEHOW." THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449804 ↗
• MalfunctionJan 5, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR ERCP CANNULA WAS BEING PREPARED FOR USE IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTICED THAT THERE WAS A DAMAGE ON THE PACKAGING OF THE DEVICE, AND "THE PACKAGE WAS NOT SEALED SOMEHOW." THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449630 ↗
• MalfunctionFeb 16, 2023Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE RAPID EXCHANGE, THREE TANDEM XL, AND TWO CONTOUR ERCP CANNULA USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE WAS USED IN THE "SMALL BOWEL" DURING A DUODENAL STENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE RAPID EXCHANGE OVER THE GUIDEWIRE. SIMILAR PROBLEM HAPPENED WHEN ANOTHER THREE TANDEM XL AND TWO CONTOUR ERCP CANNULA WERE USED. IT WAS REPORTED THAT THE DEVICES WERE "SEEMED TO BE INCOMPATIBLE." THE PATIENT WAS RESCHEDULED FOR ANOTHER PROCEDURE TO HAVE THE STENT PLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16391806 ↗
• MalfunctionFeb 16, 2023Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE RAPID EXCHANGE, THREE TANDEM XL, AND TWO CONTOUR ERCP CANNULA USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE WAS USED IN THE "SMALL BOWEL" DURING A DUODENAL STENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE RAPID EXCHANGE OVER THE GUIDEWIRE. SIMILAR PROBLEM HAPPENED WHEN ANOTHER THREE TANDEM XL AND TWO CONTOUR ERCP CANNULA WERE USED. IT WAS REPORTED THAT THE DEVICES WERE "SEEMED TO BE INCOMPATIBLE." THE PATIENT WAS RESCHEDULED FOR ANOTHER PROCEDURE TO HAVE THE STENT PLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390871 ↗
• MalfunctionApr 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR ERCP CANNULA WAS INTENDED TO BE USED IN THE COMMON BILE DUCT (CBD) IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE PACKAGING WAS DAMAGED AS THERE WAS A TEAR IN THE STERILE POUCH. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14218875 ↗