V-Trak 7110-0728-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777023728), received between Jul 23, 2021 and Mar 6, 2024 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH A RAGE CLINICAL STUDY, THE PATIENT PRESENTED WITH HYDROCEPHALUS AND INITIAL SUBARACHNOID HEMORRHAGE, BUT THIS CONDITION WORSENED 26 DAYS AFTER THE PROCEDURE. THE PATIENT WAS TREATED WITH AN EXTRA VENTRICULAR DRAIN. IT WAS EVENTUALLY REMOVED, BUT THE PATIENT BECAME PROGRESSIVELY SYMPTOMATIC FROM THE HYDROCEPHALUS. A LUMBAR DRAIN WAS INSERTED ON (B)(6) 2021 TO TEMPORIZE THE PATIENT AND TEST THE CSF. A VENTRICULOPERITONEAL DRAIN WAS INSERTED ON (B)(6) 2021. AE OUTCOME: RESOLVED WITHOUT SEQUELAE.

  Patient problems: Hydrocephalus

  MAUDE report 18852660 ↗
• MalfunctionJul 6, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A LEFT VERTEBRAL ARTERIOVENOUS FISTULA (AVF) EMBOLIZATION PROCEDURE, THE COIL STRETCHED AND UNRAVELED PRIOR TO DETACHMENT. THE COIL STRETCHED SIGNIFICANTLY LEAVING TOO FINE OF A WIRE AND TOO LONG TO BE ABLE TO SNARE OR CAPTURE. THE COIL WAS LEFT IMPLANTED IN THE PATIENT. SUBSEQUENT COILS WERE PLACED SUCCESSFULLY AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14937290 ↗
• InjuryJul 23, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TREATMENT OF A POSTERIOR COMMUNICATING ARTERY SUBARACHNOID HEMORRHAGE, AN EMBOLIZATION COIL IMPLANT WAS UNABLE TO BE RETRACTED INTO THE MICROCATHETER DURING REPOSITIONING AND UNEXPECTEDLY DETACHED. A PORTION OF THE IMPLANT COIL WAS PROTRUDING INTO THE PARENT VESSEL. A SNARE WAS USED TO REMOVE MOST OF THE COIL FROM THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE "DOING FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221750 ↗