V-Trak 7110-0715-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777023711), received between Feb 21, 2019 and Apr 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2021Unraveled Material; Separation Failure; Unraveled Material; Separation Failure

  IT WAS REPORTED THAT DURING TREATMENT OF A RUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING ARTERY, AN EMBOLIZATION COIL IMPLANT COULD NOT BE RETRACTED INTO THE MICROCATHETER. ATTEMPTS TO DETACH THE IMPLANT WITH A DETACHMENT CONTROLLER DID NOT WORK. ALL ACCESS DEVICES WERE WITHDRAWN AND THE IMPLANT AND PORTION OF THE PUSHER WIRE WERE LEFT IN THE VASCULATURE FROM THE PCOM TO THE FEMORAL ACCESS POINT. THE PATIENT'S STATUS IS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750666 ↗
• MalfunctionFeb 21, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF A RUPTURED ANEURYSM IN THE OPHTHALMIC LEFT INTERNAL CAROTID ARTERY (ICA), TWO COILS WERE PLACED IN THE ANEURYSM WITHOUT ISSUE. A THIRD COIL WAS PLACED WITHIN THE ANEURYSM BUT WOULD NOT DETACH. THE PHYSICIAN DECIDED TO REMOVE THE COIL AFTER TWO ATTEMPTS OF FAILED DETACHMENT. DURING REMOVAL, THE COIL DETACHED INTO TWO (2) PIECES IN THE MICROCATHETER. BOTH SEGMENTS WERE REMOVED IN THEIR ENTIRETY FROM THE PATIENT ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT AND THE PATIENT WAS REPORTED TO BE STABLE POST-OPERATIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360252 ↗