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UniFuse 12401816Recalls & reported problems

Angiodynamics, Inc. · UniFuse Infusion System w/ Cooper Wire · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787124018160), received between Jul 31, 2019 and Jul 31, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 31, 2019Fracture; Fracture

    PATIENT HAD A RIGHT DVT. A UNIFUSE SYSTEM WAS USED TO DISSOLVE THROMBOSIS. AFTER 5 DAYS, THE CATHETER WAS FOUND BROKEN WHEN IT WAS REMOVED FROM THE BODY. THE CATHETER FRAGMENT WAS SUCCESSULLY REMOVED. THE CATHETER WAS REPLACED WITH A NEW OF THE SAME DEVICE TO COMPLETE THE TREATMENT OF THE DVT. THE PATIENT DID NOT SUFFER ANY HARM OR INJURY DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8845466 ↗

Other Catheter, continuous flush devices

All Catheter, continuous flush devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.