V-Trak 7110-0931-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777023759), received between Mar 27, 2019 and Oct 11, 2022 — classified as 2 malfunctions.

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

• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, TWO (2) CONSECUTIVE COILS DID NOT FIT THROUGH THE MICROCATHETER. BOTH COILS STARTED TO CATCH IN THE LUMEN AND DETACHED IN THE CATHETER PRIOR TO USE OF THE CONTROLLER. THE COILS WERE REMOVED IN ONE PIECE, AND ADDITIONAL COILS WERE USED FOR THE REMAINDER OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580764 ↗
• MalfunctionMar 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING VENOUS SINUS EMBOLIZATION FOR A DURAL ARTERIOVENOUS FISTULA, THE COIL DETACHED WITHOUT USE OF THE CONTROLLER DURING REMOVAL FROM THE COIL MASS. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457874 ↗