V-Trak 7110-0254-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777025425), received between Jul 25, 2018 and Apr 1, 2025 — classified as 1 injury, 2 malfunctions.

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.

• InjuryApr 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: HYDROSOFT COIL MIGRATED AFTER SUCCESSFUL BALLOON ASSISTED COILING INTERVENTION FROM THE SAME LEFT A1 ANEURYSM. THE A2 DID NOT HAVE FLOW FOR SEVERAL MINUTES AND THE TOTAL TIME UNTIL FULL FLOW WAS RESTORED WAS A TOTAL OF 1 HOUR; THIS RESULTED IN A STROKE. DR. DID NOT PERFORM STENT ASSISTED COILING BECAUSE THE CORRECT LENGTH DEVICE WAS NOT ON THEIR SHELF AND HE DID NOT WANT TO COVER THE ANTERIOR CHORIDAL. DR. TRIED TO RETRIEVE THE COIL WITH A THROMBUS RETRIEVAL DEVICE (2 PASSES) AND SMALL MICROSNARE ALONG WITH ASPIRATION. THE DECISION WAS MADE TO UTILIZE A STENT 2.5X23 (172020) TO KEEP THE COIL ALONGSIDE A1 SEGMENT VESSEL WALL AND RESTORE FLOW. A1 EXPERIENCED VESSEL SPASM, BUT NO EVIDENCE OF ANY DAMAGE CONFIRMED WITH IN SUITE CTA. THE PATIENT AFTER WAKING UP COULD NOT MOVE HIS RIGHT LEG OR ARM AND WAS APHASIC. SYMPTOMS STARTED TO IMPROVE. PATIENT IS CURRENTLY TALKING AND ABLE TO MOVE HIS RIGHT HAND, THE RIGHT LEG IS STILL NOT MOVING.

  Patient problems: Paraplegia; Stroke/CVA

  MAUDE report 21748453 ↗
• MalfunctionDec 9, 2020Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING STENT-ASSISTED COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE EMBOLIZATION COIL STRETCHED IN THE ANEURYSM AND THEN DETACHED. THE MICROCATHETER WAS REMOVED AND A STRETCHED SEGMENT OF THE COIL REMAINS IN THE PARENT ARTERY. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10980793 ↗
• MalfunctionJul 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT FOR A RUPTURED ANEURYSM, THE COIL WAS IMPLANTED. CT IMAGES TAKEN 3 DAYS LATER SHOWED THE COIL HAD DISLODGED AND MIGRATED DOWNSTREAM TO THE RIGHT DISTAL INFERIOR DIVISION. NO INTERVENTION WAS PERFORMED FOR THE MIGRATED COIL. THE INITIAL TREATMENT SITE WAS RE-COILED WITH STENT ASSISTANCE THE DAY AFTER THE CT WAS PERFORMED. THE PATIENT WAS DISCHARGED AND IS REPORTED TO BE ALERT AND ORIENTED, AND THERE ARE NO NEUROLOGIC DEFICITS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7721281 ↗