UniFuse 12401814Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787124018140), received between Apr 8, 2020 and Apr 8, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionApr 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  WHEN INSERTING THE UNINFUSED SYSTEM CATHETER TIP INTO A SHEATH TUBE, DURING A PROCEDURE, IT WAS DISCOVERED THAT THE MARK RING OF THE CATHETER TIP HAD FALLEN OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNIFUSE AND NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED BY THE END USER. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9939876 ↗
• MalfunctionApr 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  WHEN INSERTING THE UNIFUSE SYSTEM CATHETER TIP INTO A SHEATH TUBE, DURING A PROCEDURE, IT WAS DISCOVERED THAT THE MARK RING OF THE CATHETER TIP HAD FALLEN OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNIFUSE AND NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED BY THE END USER. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9939825 ↗