V-Trak VFC061020-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777022677), received between Oct 2, 2020 and Mar 31, 2026 — classified as 2 injuries, 2 malfunctions.

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 18, 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.

• MalfunctionMar 31, 2026Premature Separation

  IT WAS REPORTED THAT DURING AN ANEURYSM TREATMENT PROCEDURE, ONE OF THE COILS FAILED TO DETACH USING TWO DETACHMENT CONTROLLERS. THE USER DECIDED TO REMOVE THE CATHETER TO REMOVE THE COIL. REPORTEDLY, DURING REMOVAL, THE COIL UNINTENTIONALLY DETACHED FROM THE CATHETER. THE CATHETER AND COIL WERE REMOVED FROM THE PATIENT. THE USER THEN PERFORMED A TEST USING BOTH DETACHMENT CONTROLLERS, BUT NEITHER WORKED ON THIS COIL. THE CONTROLLERS WORKED ON A COIL FROM ANOTHER BATCH, ALLOWING THE PROCEDURE TO CONTINUE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743018 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE WAVE CLINICAL STUDY THAT A PATIENT WAS TREATED FOR A RUPTURED BIFURCATION ANEURYSM, LOCATED ON THE LEFT ANTERIOR COMMUNICATING ARTERY (ACOM). THE ANEURYSM RUPTURED ON (B)(6) 2025, THE TREATMENT CONSISTED OF USING A COMPETITOR STENT AND THREE EMBOLIZATION COIL IMPLANTS. ON (B)(6) 2025 (1 DAY POST PROCEDURE) SAE1: MULTIFOCAL INFARCTS WERE OBSERVED IN ACA TERRITORIES LEFT > RIGHT. THE EVENT (INFARCTS) WAS DEEMED POSSIBLY RELATED TO THE COIL DEVICE, POSSIBLE RELATED TO THE STENT DEVICE, PROBABLY RELATED TO THE INDEX ENDOVASCULAR PROCEDURE, AND POSSIBLY RELATED TO THE STUDY DISEASE CONDITION. THE EVENT IS NOT ATTRIBUTABLE TO DEVICE MALFUNCTION. THE ACTION TAKEN FOR THIS EVENT WAS AN ENDOVASCULAR TREATMENT WITH ¿INTRA-ARTERIAL APPLICATION OF NIMODIPINE¿. THE PATIENT WAS LATER REPORTED TO HAVE PASSED AWAY DUE TO SEVERE VASOSPASM. HOWEVER, THE VASOSPASM WAS DEEMED TO BE UNRELATED TO THE COIL DEVICE, NOT RELATED TO THE STENT DEVICE AND NOT RELATED TO THE INDEX ENDOVASCULAR PROCEDURE. THE EVENT IS NOT RELATED TO THE CONCURRENT DISEASE CONDITION OR TREATMENT, CAUSAL RELATIONSHIP WITH THE STUDY DISEASE CONDITION REPORTED. NO ACTION TAKEN FOR THIS EVENT. THE EVENT OU

  Patient problems: Ruptured Aneurysm; Stroke/CVA

  MAUDE report 22013949 ↗
• InjuryJan 23, 2021Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE PUSHER COIL WAS NOTED TO HAVE DETACHED PRIOR TO THERMAL DETACHMENT OF THE IMPLANT COIL WITH THE CONTROLLER. THE COIL REMAINS IMPLANTED IN THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 11219873 ↗
• MalfunctionOct 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A CAVERNOUS SINUS FISTULA, THE EMBOLIZATION COIL UNEXPECTEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10622849 ↗