Fusion Titan G49220Recalls & reported problems
Cook Incorporated · Fusion Titan Biliary Dilation Balloon 3.2mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002492202), received between Feb 15, 2018 and Feb 15, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
- Hole In Material1
- Inflation Problem1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2018Burst Container or Vessel
IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE BALLOON BURST ON THE FIRST INFLATION. THE PHYSICIAN REMOVED THE DEVICE AND USED ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES, AND NO PIECES OF THE DEVICE WERE LEFT IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7273509 ↗MalfunctionFeb 15, 2018Inflation Problem; Leak/Splash
THE COMPLAINANT REPORTED THAT THE BALLOON WOULD NOT HOLD PRESSURE WHEN IT WAS INFLATED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY). THE BALLOON WAS REMOVED FROM THE PATIENT AND INFLATED; THE LEAK WAS NOTED NEAR THE DISTAL TIP OF THE BALLOON. ANOTHER DEVICE OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7272573 ↗MalfunctionFeb 15, 2018Hole In Material
THE COMPLAINANT REPORTED THAT THERE WAS A TINY HOLE IN THE END OF THE DEVICE. A NEW DILATION BALLOON WAS OPENED AND USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE PROCEDURE TOOK A LITTLE LONGER TO PERFORM, BUT THERE WERE NO ADDITIONAL EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7272570 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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