V-Trak 8410-0306-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777021267), received between May 5, 2025 and May 5, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Unraveled Material” (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.

• InjuryMay 5, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED: DURING TREATMENT OF ACUTELY RUPTURED ACOMM ANEURYSM, A SCEPTER XC WAS PLACED IN RIGHT M2 BRANCH AND A HEADWAY 17 MICROCATHETER WAS PLACED INTO THE BILOBED ANEURYSM. SUCCESSFUL DELIVERY OF 3 TERUMO NEURO COILS WAS PERFORMED WITH BALLOON INFLATION WITHOUT INCIDENT. THE FOURTH COIL WAS ATTEMPTED TO PLACE WITH REPOSITIONING OF THE COIL INTO THE EXISTING COIL MASS 3-4 TIMES. THE PHYSICIAN REALIZED THE COIL HAD STRETCHED AND DECIDED TO TAKE A SNARE OVER THE HEADWAY 17 MICROCATHETER AND WAS ABLE TO SUCCESSFULLY RETRIEVE THE STRETCHED COIL OUT OF THE PATIENT. THE COIL WAS NEVER DETACHED. IT HAD STRETCHED AND WAS STILL PARTIALLY IN THE ANEURYSM SAC UPON RETRIEVAL. THE INDWELLING COIL MASS WAS UNAFFECTED BY THE REMOVAL OF THE STRETCHED COIL. NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SUBARACHNOID HEMORRHAGE (SAH); IT WAS PRE-EXISTING AND NOT CAUSED BY THE PROCEDURE. THEY ARE UNABLE TO TELL CONDITION / OUTCOME CURRENTLY AND NO UPDATE ON PATIENT CONDITION IS AVAILABLE AS OF REPORT DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965064 ↗