Fusion Titan G49222Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002492226), received between Feb 15, 2018 and Feb 16, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2018Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT WHILE ATTEMPTING TO INFLATE THE BALLOON IN THE DISTAL BILE DUCT, IT WAS FOUND TO BE LEAKING FROM THE TAIL END. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES. NO PIECES OF THE DEVICE WERE LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7276567 ↗
• MalfunctionFeb 15, 2018Fluid/Blood Leak; Inflation Problem; Decrease in Pressure

  THE COMPLAINANT REPORTED THAT THE PRESSURE GAUGE WOULDN¿T GO UP DURING BALLOON INFLATION. THE BALLOON WAS INSERTED INTO THE CBD (COMMON BILE DUCT) AND A LEAK WAS DISCOVERED WHEN THE BALLOON WAS REMOVED; THE HOLE WAS NOTED TO BE IN THE DISTAL SECTION OF THE BALLOON. THE ERCP (ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY) PROCEDURE WAS COMPLETED WITH A NEW BALLOON. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7273422 ↗