V-Trak 8410-0308-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777025159), received between Feb 10, 2017 and Feb 10, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 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.

• InjuryFeb 10, 2017Detachment Of Device Component; Migration or Expulsion of Device; Difficult To Position; Stretched; Detachment Of Device Component; Migration or Expulsion of Device; Difficult To Position; Stretched

  IT WAS REPORTED THAT STENT-ASSISTED COILING WAS PERFORMED ON A PREVIOUSLY COILED ANTERIOR CEREBRAL ARTERY (ACA) ANEURYSM. AFTER IMPLANTATION OF SEVERAL COILS, THE HYPERSOFT 3D COIL WAS PLACED; HOWEVER, PART OF THE COIL WAS NOTED TO BE LOOPING INTO THE IPSILATERAL A2 ARTERY. DURING AN ATTEMPT TO SLOWLY REMOVE THE COIL, THE COIL DETACHED AFTER APPROXIMATELY 10MM OF THE COIL HAD BEEN WITHDRAWN. THE PUSHER WIRE WAS REMOVED AND THE JAILED CATHETER WITH THE COIL INSIDE WAS PULLED BACK INTO THE PROXIMAL ACA. THE COIL LOOPS THAT WERE NOTICED IN THE IPSILATERAL A2 WERE GONE; HOWEVER, THE DETACHED COIL THAT WAS NOT JAILED BY THE STENT TRAVELED TO THE MIDDLE CEREBRAL ARTERY (MCA). A STENT WAS IMPLANTED IN THE MCA TO TRAP THE DETACHED COIL SEGMENT. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6324601 ↗