Cotton Cannulatome II G22537Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002225374), received between Mar 17, 2016 and Nov 11, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME. IT WAS REPORTED THAT THE CUTTING WIRE WAS BROKEN SO THE PHYSICIAN CHANGED TO ANOTHER ONE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 16OCT2025 AND IT WAS DETERMINED THAT THE ANCHOR HAD SEPARATED FROM THE TIP [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23527960 ↗
• MalfunctionJun 10, 2020Material Separation; Material Separation

  PRIOR TO AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE NURSE ASSISTANT PREPARED A COOK COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME. THE NURSE ASSISTANT THAT OPENED THE PACKAGE NOTICED THE CUTTING WAS SEPARATED AT THE SOLDER JOINT INSIDE THE TIP OF THE CATHETER AND WAS STARTING TO COME OUT OF THE CATHETER [CUTTING WIRE SECURING COMPONENT SEPARATION]. IT WAS NEVER ADVANCED INTO THE ENDOSCOPE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10139096 ↗
• MalfunctionMar 28, 2016Failure to Align; Failure to Align

  THIS FOLLOW UP MEDWATCH REPORT IS BEING SUBMITTED TO PROVIDE NEW INFORMATION [DEVICE EVALUATION] AND CORRECTED INFORMATION. DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. DURING THE ARC VOLTAGE [APPLICATION OF CURRENT AND BOWING OF THE TIP], THE SPHINCTEROTOME DEFLECTS TO THE LEFT [INCORRECT CUTTING WIRE ORIENTATION]. EIGHT (8) SPHINCTEROTOMES WERE USED IN ORDER TO CARRY OUT THE PROCEDURE. FIVE (5) OF THE SPHINCTEROTOMES USED IN THE PROCEDURE ARE INCLUDED IN THIS REPORT. SEE RELATED MEDWATCH REPORT NUMBERS 1037905-2016-00066 & 1037905-2016-00067.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5528972 ↗
• MalfunctionMar 17, 2016Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME. UPON ACTIVATING CUTTING ENERGY [CUTTING FUNCTION OF THE ELECTROSURGICAL GENERATOR], THE CUTTING WIRE GOT TORN FROM ONE SIDE [CUTTING WIRE BROKE IN ONE LOCATION]. ON (B)(4) 2016, WE RECEIVED THE FOLLOWING INFORMATION: THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF DEVICE. NO SECTION OF THE DEVICE REMAINED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5507032 ↗