Fusion Titan G49219Recalls & reported problems
Cook Incorporated · Fusion Titan Biliary Dilation Balloon 3.2mm · Class 2
Data updated Oct 16, 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 00827002492196), received between Aug 4, 2017 and Feb 15, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Hole In Material” (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 16, 2026.
Most reported problems
Device problems
- Hole In Material3
- Inflation Problem2
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2018Hole In Material; Inflation Problem
IT WAS REPORTED THAT WHEN THE USER TRIED TO DILATE THE STRICTURE, THE BALLOON WOULD NOT INFLATE. THEY THEN REMOVED THE BALLOON AND ATTEMPTED TO INFLATE IT OUTSIDE THE PATIENT, AND THEY FOUND THAT THERE WAS A HOLE IN THE BALLOON. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES, AND NO PIECES OF THE DEVICE REMAINED IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7273539 ↗MalfunctionFeb 15, 2018Hole In Material; Inflation Problem
THE COMPLAINANT REPORTED THAT MAXIMUM PRESSURE WAS APPLIED (12 ATM) AND THE BALLOON DID NOT FULLY INFLATE. THE BALLOON WAS REMOVED FROM THE PATIENT AND A SMALL HOLE WAS FOUND IN THE BALLOON. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7272568 ↗MalfunctionAug 4, 2017Hole In Material; Hole In Material
CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING AN ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY (ERCP) USING A FUSION TITAN DILATION BALLOON. THE BALLOON FAILED TO INFLATE DURING THE PROCEDURE. THE DEVICE WAS EXCHANGED WITH A NEW FUSION TITAN DILATION BALLOON TO COMPLETE THE PROCEDURE. THE CUSTOMER THEN ATTEMPTED TO INFLATE THE INITIAL BALLOON AFTER THE PROCEDURE AND EXTERNAL TO THE SCOPE AND PROCEDURE; A HOLE WAS DISCOVERED IN THE BALLOON. THE SOURCE OF THE HOLE IS NOT KNOWN. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6767051 ↗
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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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