UniFuse 12401802Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787124018020), received between Jun 20, 2017 and Jul 2, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: DURING A DECLOT PROCEDURE, USING A 5FR 45CM X 10CM UNIFUSE INFUSION CATHETER ON (B)(6) 2018, THE TECH WAS TRYING TO PUT THE CATHETER IN THE DIALYSIS GRAFT WHEN HE SAW ON FLUORO THAT THE DISTAL MARKER WAS GETTING CLOSE TO THE PROXIMAL MARKER. HE STOPPED ADVANCING THE CATHETER WHEN HE NOTICED THE MARKER MOVEMENT AND CALLED A PHYSICIAN TO ASSIST. THE MARKER DID NOT MAKE IT INTO THE GRAFT, BUT IT WAS RIGHT AT THE INSERTION SITE IN THE TISSUE. THE DOCTOR HAD TO MAKE AN INCISION AND WAS ABLE TO DIG IT OUT. THE DEVICE WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT WAS NOT HARMED OR INJURED 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 7656091 ↗
• InjuryOct 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: THE PATIENT UNDER WENT A DECLOT PROCEDURE IN A FISTULA IN AN UPPER EXTREMITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, AS THE CATHETER WAS BEING REMOVED, IT WAS NOTED THE TIP/MARKER BAND HAD DETACHED INSIDE OF THE PATIENT. THE TIP/MARKER BAND WAS SUCCESSFULLY REMOVED WITH NO REPORT OF PERMANENT HARM OR INJURY TO THE PATIENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6986727 ↗
• InjuryJul 17, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: DURING AN INFUSION PROCEDURE, IT WAS NOTED THE MARKER BAND HAD SLIPPED OFF THE CATHETER AND INTO THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE MARKER BAND FROM THE PATIENT VIA A SNARE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THE EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6716902 ↗
• MalfunctionJun 20, 2017Detachment Of Device Component; Fracture; Detachment Of Device Component; Fracture

  BASED ON SAMPLE RECEIVED BY ANGIODYNAMICS ON JUNE 13 2017: IT WAS ORIGINALLY REPORTED BY THE USER ON (B)(6) 2016 THAT THERE WAS A "FAULT WITH THE APPLICATOR". A FAILURE MODE OF "FAULT" WOULD NOT BE CONSIDERED A REPORTABLE EVENT. HOWEVER, BASED ON THE SAMPLE EVALUATION PERFORMED ON JUNE 13 2017, IT WAS NOTED THE TIP OF THE APPLICATOR HAD FRACTURED OFF. THIS FAILURE MODE OF "FRACTURE" MEETS THE CRITERIA OF REPORTABILITY. THERE WAS NO REPORT OF PATIENT HARM OR INJURY DUE TO THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6653296 ↗