UniFuse 12401803Recalls & reported problems
Angiodynamics, Inc. · UniFuse Infusion System w/ Cooper Wire · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI H787124018030), received between Sep 20, 2023 and Mar 18, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body In Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH A CATHETER FROM A UNI 5FX45CMX15CM UNIFUSE SYSTEM KIT. THEY INSERTED THE CATHETER AND INFUSED THE MEDICINE. AFTER 45 MINUTES THEY BROUGHT THE PATIENT INTO THE ROOM, AND THEY STARTED THE PROCEDURE. AS THEY ATTEMPTED TO REMOVE THE CATHETER, ONE OF THE MARKERS WAS LEFT BEHIND IN THE PATIENT. THE MARKER WAS IN THE FOREARM OF THE PATIENT, AND RETRIEVED BY FLUSHING IT OUT WHEN THE SHEATH WAS PULLED OUT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 18920661 ↗MalfunctionMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH A CATHETER FROM A UNI 5FX45CMX15CM UNIFUSE SYSTEM KIT. THEY INSERTED THE CATHETER AND INFUSED THE MEDICINE. AFTER 45 MINUTES THEY BROUGHT THE PATIENT INTO THE ROOM, AND THEY STARTED THE PROCEDURE. AS THEY ATTEMPTED TO REMOVE THE AN END USER REPORTED AN ISSUE WITH TWO CATHETERS FROM TWO DIFFERENT UNI 5FX45CMX15CM UNIFUSE SYSTEM KITS DURING THE SAME PROCEDURE. WE DID A THROMBECTOMY ON A 73-YEAR-OLD FEMALE. WE USED TWO 15CM UNIFUSE CATHETERS. AS WE ATTEMPTED TO REMOVE THE CATHETER, ONE OF THE MARKERS WAS LEFT BEHIND IN THE PATIENT. WE PUT THE 7F SHEATH IN THE ARM AND WHEN WE REMOVED THE DILATOR IT WAS PUSHED TIGHTLY OVER THE TIP SO WE WERE ABLE TO RETRIEVE IT WITH NO TROUBLE. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 18920658 ↗MalfunctionOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AN END USER REPORTED AN ISSUE WITH A UNI (B)(4) UNIFUSE SYSTEM. DURING A PROCEDURE, THE MARKERS CAME OFF OF THE DEVICE, WHILE IT WAS BEING INSERTED INTO THE PATIENT. THE MARKERS WERE ABLE TO BE RETRIEVED, ALONG WITH THE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18041478 ↗MalfunctionSep 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A REGIONAL BUSINESS MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A UNIFUSE 5FX45CMX15CM UNIFUSE SYSTEM. WHEN THEY REMOVE THE CATHETER TO BEGIN THE CASE, THE MARKER COMES OFF THE CATHETER AND NEEDS TO BE RETRIEVED FROM INSIDE THE PATIENT, VIA SNARE. ULTIMATELY, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17783089 ↗MalfunctionSep 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A REGIONAL BUSINESS MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A UNIFUSE 5FX45CMX15CM UNIFUSE SYSTEM. WHEN THEY REMOVE THE CATHETER TO BEGIN THE CASE, THE MARKER COMES OFF THE CATHETER AND NEEDS TO BE RETRIEVED FROM INSIDE THE PATIENT, VIA SNARE. ULTIMATELY, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17783086 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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