V-Trak 7310-1030-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777023452), received between Jul 6, 2018 and Mar 2, 2023 — classified as 2 injuries.

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 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.

• InjuryMar 2, 2023Difficult or Delayed Positioning; Malposition of Device; Detachment of Device or Device Component; Difficult or Delayed Positioning; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT AS THE COIL WAS BEING PLACED IN A PATIENT, IT WAS DETERMINED TO NOT BE IN THE CORRECT POSITION FOR DEPLOYMENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICE; HOWEVER, WHILE REMOVING THE DEVICE, THE COIL BECOME DETACHED, OR STRETCHED TO THE POINT THAT THE COIL WAS NOT SUCCESSFULLY REMOVED FROM THE BODY AND REMAINED IN THE COIL MASS WITH A "TAIL" IN THE PATIENT¿S NATIVE ANATOMY. THE COIL AND THE DELIVERY CATHETER WERE REMOVED. THE PHYSICIAN WENT TO CROSS THE ANEURYSM NECK WITH A TRAXCESS WIRE; HOWEVER, IT SUBSEQUENTLY GOT STUCK SOMEWHERE WITHIN THE PRIOR STENT OR COIL TAIL. THIS WIRE WAS THEN TWISTED UNTIL THE DISTAL TIP BROKE OFF AND REMAINED IN THE PATIENT, THE REMAINDER OF THE WIRE WAS REMOVED. THE COIL WAS REPORTED TO BE IN THE PARENT ARTERY POST PROCEDURE; THUS, INTERVENTION WITH A STENT WAS PERFORMED. THE PATIENT WAS REPORTED TO BE DOING GOOD. THIS REPORT ADDRESSED THE COIL USED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474748 ↗
• InjuryJul 6, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, PART OF THE EMBOLIZATION COIL DETACHED IN THE ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE COIL; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL AND THE PATIENT WAS TAKEN TO SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7666688 ↗