UniFuse 12401822Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787124018220), received between Jul 9, 2020 and Jul 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K163356); they may or may not involve this specific model.

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

• MalfunctionJul 9, 2020Fracture; Fracture

  A DISTRIBUTOR REPORTED THAT A UNI 4.3FX135CMX20CM UNIFUSE SYSTEM WAS IMPLANTED INTO A PATIENT TO DISSOLVE A THROMBOSIS. THE CATHETER WAS LATER DISCOVERED TO BE BROKEN, AFTER THE OPERATION. THE PATIENT REQUIRED AN ADDITIONAL OPERATION TO REPLACE THE CATHETER WITH ANOTHER SAME DEVICE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED BY THE END USER. IT WAS REPORTED THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10254566 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163356. One submission often covers many models, so check the product and lot details in each record.

• Z-1010-2024 · Dec 18, 2023 · Open, Classified
  PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5