V-Trak 7118-2048-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777024039), received between Dec 15, 2021 and Mar 19, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Stretched; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS TREATING AN ARTERIOVENOUS MALFORMATION (AVM) USING BOTH MICROVENTION COILS AND COMPETITOR COILS. THE PHYSICIAN DEPLOYED ONE OF THE COMPETITOR COILS FIRST AND THEN PROCEEDED WITH THE MICROVENTION DEVICE. AFTER DEPLOYMENT THE PHYSICIAN WAS ATTEMPTING TO GET THE DEVICE TO FORM IN THE INTENDED LOCATION, AND DURING POSITIONING HALF OF THE COIL WAS IN THE VEIN AND THE OTHER HALF PREMATURELY DETACHED IN THE MICROCATHETER IN THE AORTA. AFTER UNSUCCESSFUL ATTEMPTS TO SNARE THE COIL, HE PROCEEDED WITH THE EMBOLIZATION. THE COIL WAS LEFT IN THE PATIENT AND COMPLETED THE EMBOLIZATION WITH THE PROXIMAL END OF THE COIL IN THE AORTA. NO ADDITIONAL PATIENT INFORMATION WAS MADE AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640511 ↗
• InjuryDec 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ELECTIVE PROCEDURE ON GIANT RIGHT MCA ANEURYSM, THE FIRST EMBOLIZATION COIL IMPLANT PLACED IN THE ANEURYSM UNEXPECTEDLY DETACHED. THE IMPLANT WAS ENTIRELY WITHIN THE ANEURYSM. THERE WAS AN INTRA-PROCEDURAL RUPTURE DURING THE CASE. IT IS NOT KNOWN HOW THE RUPTURE OCCURRED AND A COMPETITOR'S COILS WERE USED AS WELL. PROTAMINE WAS ADMINISTERED AND A BALLOON WAS UTILIZED TO ARREST BLEEDING. THE PATIENT'S STATUS WAS REPORTED TO BE "GOOD" AFTER THE PROCEDURE. LATER THE PATIENT WAS REPORTED TO BE DYSARTHRIC, LIKELY FROM A RIGHT FRONTAL STROKE, AND SHOULD LIKELY RECOVER WITH TIME AND REHAB. THE PHYSICIAN STATED THAT IT IS PROBABLE THAT A SMALL PLAQUE CAUSED AN EMBOLISM WHEN ACCESSING THE CAROTID ORIGINS.

  Patient problems: Ruptured Aneurysm; Stroke/CVA

  MAUDE report 13014033 ↗