V-Trak 7310-0720-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777023421), received between Mar 20, 2020 and Mar 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or 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. How this data works · Data updated Oct 13, 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, 2020Difficult or Delayed Positioning; Difficult to Remove; Stretched; Detachment of Device or Device Component; Difficult or Delayed Positioning; Difficult to Remove; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT STENT-ASSISTED COILING WAS PERFORMED FOR A LARGE ANEURYSM IN A TORTUOUS VESSEL. AFTER SEVERAL COILS HAD BEEN PLACED, THE EMBOLIZATION COIL COULD NOT FIT ENTIRELY IN THE ANEURYSM. AFTER 6-7 MINUTES OF COIL RETRACTION AND ADVANCEMENT ATTEMPTS, 1:1 MOVEMENT WAS LOST. DURING ATTEMPTED COIL REMOVAL, THE COIL STRETCHED. A GOOSENECK SNARE WAS USED TO ASSIST WITH COIL REMOVAL AND THE COIL DETACHED. THE IMPLANT COIL WAS LEFT IN PLACE WITH SOME COIL EXTENDING OUTSIDE THE ANEURYSM AND THE PATIENT WAS PUT ON DUAL ANTIPLATELET/ASA THERAPY POST-PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862431 ↗