V-Trak 7110-0520-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777025265), received between Feb 12, 2019 and Jun 23, 2023 — classified as 1 injury, 1 malfunction.

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. 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.

• InjuryJun 23, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A WEB/STENT ASSISTED COIL EMBOLIZATION PROCEDURE, A COIL STRETCHED AND STOPPED RESPONDING WHEN THE PHYSICIAN WAS RE-POSITIONING IT WITHIN THE ANEURYSM. THE PHYSICIAN NOTED A ¿POP¿, THE COIL WAS NOT MOVING ¿ONE-TO-ONE¿ AND THAT THE COIL WAS STRETCHED. AN ATTEMPT WAS MADE TO REMOVE THE COIL FROM THE ANEURYSM BY GENTLY MANIPULATING IT, BUT THE COIL WAS NOT MOVING BACK INTO THE MICROCATHETER. THE PHYSICIAN INSERTED A BALLOON CATHETER TO PROTECT ONE OF THE BRANCHES AND THEN REMOVED THE COIL. DURING REMOVAL, IT APPEARED THAT A PORTION OF THE COIL WAS STILL WITHIN THE MICROCATHETER, AND THE MAJORITY OF THE COIL WAS WITHIN THE ANEURYSM. THE PHYSICIAN USED A GUIDEWIRE AND DESPITE RESISTANCE WAS ABLE TO PUSH THE REMAINING STRETCHED COIL BACK INTO THE ANEURYSM. THE PHYSICIAN ADVANCED THE PROXIMAL COIL¿S RADIOPAQUE MARKER AND COIL FILAMENT INTO THE ANEURYSM. ANGIOGRAMS WERE PERFORMED AND VERIFIED THAT THE STRETCHED COIL WAS IMPLANTED INSIDE THE ANEURYSM AND THEN THE PHYSICIAN MOVED FORWARD TO COMPLETE THE PROCEDURE. THE FOLLOWING DAY THE PATIENT WAS AWAKE AND IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195840 ↗
• MalfunctionFeb 12, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, AN ATTEMPT WAS MADE TO DETACH THE COIL WITH THE CONTROLLER; HOWEVER, THE COIL DID NOT DETACH. DURING REMOVAL, THE COIL DETACHED IN THE MICROCATHETER. APPROXIMATELY 2CM OF THE COIL WAS EASILY PUSHED INTO THE ANEURYSM WITH THE COIL PUSHER AND IMPLANTED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331463 ↗