V-Trak 7118-1644-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777024015), received between Mar 20, 2025 and Mar 20, 2025 — classified as 1 injury.

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

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 16, 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.

• InjuryMar 20, 2025Stretched; Separation Problem; Stretched; Separation Problem

  AS REPORTED: DURING TREATMENT OF A LARGE SIDEWALL ANEURYSM, USING A MICROCATHETER 156, FULLY DELIVERED THE HYDROFRAME COIL, BUT IT WOULD NOT DETACH WITH TWO DETACHMENT CONTROLLERS. SEQUENCE OF EVENTS: DEPLOYED HALF OF A FLOW DIVERTER, COILED, THEN MORE FLOW DIVERTER DEPLOYED, BUT NOT FULLY DEPLOYED. THEY PULLED THE COIL OUT AND IT STRETCHED AND DETACHED. ACCORDING TO THEM, "NO LOOPS IN PUSHER WIRE." FINISHED DEPLOYING THE FLOW DIVERTER, HAD 5-6MM OF THE CLOT RETRIEVER TO TRY AND RETRIEVE THE COIL, BUT IT DID NOT WORK. FINALLY, THERE WERE ABLE TO PULL THE MICROCATHETER INTO THE BENCHMARK; THEY VISUALIZED THE PUSHER WIRE IN THE BENCHMARK AND USED A SNARE TO GET ALL OF THE COIL. NO PATIENT INJURY, PHYSICIAN SAID PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658060 ↗