TriNav Infusion System TNV-21120-35Recalls & reported problems
Surefire Medical, Inc. · 120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857136004217), received between Apr 4, 2024 and Apr 4, 2024 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2024
ELDERLY FEMALE WITH HISTORY OF RIGHT RENAL CLEAR CELL CARCINOMA. PROCEDURE: ANGIOGRAM/EMBOLIZATION OF BRANCHES OF THE RIGHT RENAL ARTERY. DURING AN EMBOLIZATION, DR. ATTEMPTED TO INFUSION ETHANOL THROUGH A TRINAV CATHETER AND IT "MELTED." TRINAV CATHETER REMOVED INTACT, NO KNOWN HARM TO PATIENT. DISCHARGED THE NEXT DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19040146 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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