Cotton Cannulatome II G22241Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002222410), received between Feb 26, 2016 and Apr 13, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2018Material Separation; Material Separation

  DURING A SPHINCTEROTOMY, THE PHYSICIAN USED A COOK COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME. THE CUTTING WIRE BROKE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING WAS RECEIVED VIA COMPLAINT FORM DATED (B)(6) 2018: THE CUTTING WIRE BROKE DURING USE. THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF DEVICE. NOTHING DETACHED IN THE PATIENT. THEY USED A DIFFERENT CT-25 SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7430552 ↗
• MalfunctionJun 22, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME. THE CUTTING WIRE WHEN PUT UNDER TENSION TURNS THE TIP TO THE RIGHT, SO THAT THERE´S NO CANNULATION POSSIBLE [INCORRECT CUTTING WIRE ORIENTATION]. [THE USER] USED A DIFFERENT CT-25 WITHOUT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6661686 ↗
• MalfunctionFeb 26, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME. THE DEVICE WOULD NOT ANGULATE WELL. THE CUTTING WIRE OF THE SPHINCTEROTOME WOULD NOT ORIENT CORRECTLY IN RELATION TO THE PAPILLA [INCORRECT CUTTING WIRE ORIENTATION]. THEY HAD TO USE A DIFFERENT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5462809 ↗