V-Trak 7110-0405-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777023650), received between Nov 7, 2018 and Mar 31, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Unraveled Material; Difficult to Advance

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED TO TREAT A PATIENT WITH AN ACOMM ANEURYSM. REPORTEDLY, IT WAS DIFFICULT TO ADVANCE THE COIL AND THE PHYSICIAN ATTEMPTED TO PULL THE COIL BACK INTO THE SHEATH WHEN THE COIL STARTED TO UNRAVEL AND WOULD NOT GO BACK INTO THE SHEATH. THE COIL WAS REMOVED FROM THE PATIENT AND THE CASE WAS ABORTED AS THE COIL COULD NOT BE PLACED IN THE ANEURYSM. NO COILS WERE IMPLANTED DURING THE CASE. REPORTEDLY, VESSEL ANATOMY WAS THE MAIN REASON WHY PHYSICIAN WAS UNABLE TO TREAT THE ANEURYSM. AT THE END OF PROCEDURE, THE PATIENT WAS THE SAME AS PRE PROCEDURE AND CURRENTLY "BASELINE." THE PHYSICIAN PLANS TO BRING THE PATIENT TO SURGERY TO CLIP THE ANEURYSM; HOWEVER, NO DATE IS SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743085 ↗
• InjuryNov 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH A RAGE CLINICAL STUDY, AN INTERVAL UNWINDING OF COIL MASS IN THE LUMEN OF THE ANEURYSMAL CAVITY WAS SUGGESTIVE OF PREVIOUS PRESENCE OF PARTIAL THROMBOSIS WITHIN THE ANEURYSM AT THE TIME OF EMERGENT END-VASCULAR REPAIR, AS WELL AS PRESENCE OF SMALL ANEURYSM NECK RECANALIZATION, SIZE 2.5X2.6X2.2. THE PATIENT UNDERWENT RETREATMENT WITH THE PLACEMENT OF A FLOW DIVERTER. THE PATIENT EXITED THE STUDY ON THE SAME DAY AS THE RETREATMENT. NO OTHER ADVERSE EVENTS ARE REPORTED.

  Patient problems: Aneurysm; Thrombosis/Thrombus

  MAUDE report 20646776 ↗
• InjuryJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A BALLOON ASSISTED COILING PROCEDURE ON THE LEFT MIDDLE CEREBRAL ARTERY (MCA) AT THE BIFURCATION. WHILE ADVANCING THE COIL UP THE MICROCATHETER AND FIRST SEGMENT OF COIL WAS IN THE ANEURYSM, THE COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER WITHOUT ACTIVATING THE DETACHMENT CONTROLLER. A SNARE WAS USED AND SUCCESSFULLY RETRIEVED THE COIL. THERE WAS NO REPORT OF INJURY TO THE PATIENT, WHO WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942558 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UNEVENTFUL BALLOON ASSISTED COILING PROCEDURE FOR A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM WAS PERFORMED ON A PATIENT THAT PRESENTED WITH SUDDEN HEADACHE AND REDUCED CONSCIOUS LEVEL, AND SUBARACHNOID HEMORRHAGE. POST PROCEDURE, THE PATIENT WOKE UP WITH IPSILATERAL 3RD NERVE PALSY. THE CONDITION DID NOT IMPROVE WITH A SHORT COURSE OF STEROIDS, AND THE PATIENT UNDERWENT NEUROSURGICAL NERVE DECOMPRESSION TWO (2) DAYS LATER, WHICH WAS BELIEVED TO BE A RESULT OF AN IMMEDIATE MASS EFFECT OF THE COILED ANEURYSM ON THE 3RD NERVE.

  Patient problems: Neuropathy

  MAUDE report 8049356 ↗