UniFuse 12401808Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787124018080), received between Dec 20, 2017 and Dec 20, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 20, 2017Unraveled Material; Unraveled Material

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING A PROCEDURE, USING A UNIFUSE INFUSION SYSTEM, IT WAS NOTED THE OCCLUSION WIRE HAD UNRAVELED INSIDE OF THE CATHETER. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS INDICATED THAT THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133257 ↗
• MalfunctionDec 20, 2017Unraveled Material; Unraveled Material

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING A PROCEDURE, USING A UNIFUSE INFUSION SYSTEM, IT WAS NOTED THE OCCLUSION WIRE HAD UNRAVELED INSIDE OF THE CATHETER. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS INDICATED THAT THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133255 ↗