Fusion G31550Recalls & reported problems
Cook Ireland Ltd · Fusion, Pushing Catheter · Class 2
Data updated Oct 16, 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 00827002315501), received between Oct 3, 2019 and Oct 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2019Use of Device Problem; Use of Device Problem
COMPLAINT RECEIVED FROM DM VIA E-MAIL ON 05SEP2019--DID 06SEP2019. AS REPORTED TO CUSTOMER RELATIONS: "(B)(6) AND I DID AN ERCP C DR. (B)(6) IN THE OPERATING ROOM ON (B)(6) 2019 AND HAD A FEW MALFUNCTIONS WITH OUR EQUIPMENT. FIRST, WE CANNULATED THE PANCREATIC DUCT AND TRIED TO DO AN EXCHANGE USING THE 021 OMNITOME BUT THE WIRE FRAYED (B)(4). SO WE CHANGED TO A JAGTOME ONLY BECAUSE IT WAS OPENED ACCIDENTALLY. WHEN WE PLACED A 5-7 SINGLE PIGTAIL PANCREATIC STENT , I HAD A DIFFICULT TIME PULLING THE WIRE FROM THE STENT TO RELEASE IT (SEPARATE FILE CREATED TO CAPTURE THIS). (WE EVEN USED A 5 PUSHING CATHETER). THE PUSHING CATHETER WAS BUCKLING WHEN I WAS TRYING TO PULL THE WIRE BACK (THIS REPORT).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9150161 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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