Cotton G21944Recalls & reported problems
Cook Incorporated · Cotton Cannulatome · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002219441), received between Sep 9, 2016 and Sep 9, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (1 report).
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
Device problems
- Failure to Align1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2016Failure to Align; Failure to Align
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULATOME. UPON ADVANCING THE DEVICE INTO POSITION, IT WAS NOTED THAT THE ORIENTATION IS OFF, CAUSING THE WIRE TO BE UNABLE TO BOW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5939693 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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