Fusion G31529Recalls & reported problems
Cook Incorporated · Fusion Biliary Dilation Balloon · Class 2
All models of Fusion (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002315297), received between Feb 15, 2019 and Feb 25, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
Device problems
- Fluid/Blood Leak2
- Off-Label Use2
- Use of Device Problem2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2019Fluid/Blood Leak; Off-Label Use; Use of Device Problem; Fluid/Blood Leak; Off-Label Use; Use of Device Problem
DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK FUSION BILIARY DILATION BALLOON. THE USER ATTEMPTED TO DILATE THE PAPILLA, BUT LEAKAGE FROM THE BALLOON AT THE FIRST INFLATION WAS FOUND. HE REPLACED IT WITH ANOTHER FUSION BILIARY DILATION BALLOON TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8367640 ↗MalfunctionFeb 15, 2019Fluid/Blood Leak; Off-Label Use; Use of Device Problem; Fluid/Blood Leak; Off-Label Use; Use of Device Problem
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8344066 ↗
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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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