Cotton G22732Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002227323), received between Jun 2, 2017 and Apr 28, 2025 — classified as 1 injury, 2 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 16, 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 28, 2025Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK COTTON CANNULATION. IT WAS REPORTED THAT THE CUTTING WIRE ON A COTTON CANNULATOME BROKE OFF IN A PATIENT. WE [END USER] COULDN'T FIND THE WIRE IN THE SCOPE. THE PATIENT WAS SENT TO BE X-RAYED. NO WIRE WAS FOUND. THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER COTTON CANNULATOME. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025, THE PATIENT HAD A DIFFICULT ANATOMY WHICH MADE SCOPE POSITIONING AND CANNULATION VERY CHALLENGING. THEY [PHYSICIAN AND TEAM] ALSO BELIEVE THAT THE TOME WAS ROTATED DURING THE PROCEDURE TO ACHIEVE BETTER POSITIONING. IT WAS REPORTED THAT THE CUTTING WIRE BROKE OFF INSIDE THE PATIENT'S BODY. THE PATIENT WAS SENT TO BE X-RAYED. NO WIRE WAS FOUND. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920325 ↗
• InjurySep 24, 2018Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULATOME. AS REPORTED TO CUSTOMER RELATIONS: "THE CUTTING WIRE ON THIS SPHINCTEROTOME COMPLETELY CAME OFF IN THE PATIENT. THEY WERE ABLE TO RETRIEVE [THE CUTTING WIRE] WITH FORCEPS. ANOTHER SPHINCTEROTOME WAS USED SUCCESSFULLY." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE SPHINCTEROTOME CUTTING WIRE WAS RETRIEVED WITH FORCEPS DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7901544 ↗
• MalfunctionJun 2, 2017Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COTTON CANNULATOMES. THE CUTTING WIRE BROKE ON BOTH DEVICES. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICES WERE RECEIVED FOR EVALUATION ON 5/9/2017. IT WAS OBSERVED THAT ONE OF THE CUTTING WIRES WAS BROKEN AND A SECTION WAS MISSING. DURING INITIAL EVALUATION OF THE SECOND DEVICE IT WAS OBSERVED THE CUTTING WIRE BROKE IN THE MIDDLE [CUTTING WIRE BROKE IN ONE LOCATION] AND BOTH PIECES REMAINED ATTACHED TO THE DEVICE AND NO PORTION OF THE CUTTING WIRE WAS MISSING. HOWEVER, DURING FURTHER EVALUATION OF THE DEVICE A SECTION OF THE CUTTING WIRE BROKE AND DETACHED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6608527 ↗