V-Trak 100204HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777020604), received between Oct 10, 2018 and Mar 7, 2026 — classified as 1 injury, 3 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 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.

• MalfunctionMar 7, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING A PROCEDURE THE COIL DID NOT RELEASE. A SECOND CONTROLLER OF A DIFFERENT LOT WAS USED; HOWEVER, THE SAME FAILURE WAS EXPERIENCED. IT WAS REPORTED THAT STANDARD TECHNICAL RECOMMENDATIONS WERE FOLLOWED, INCLUDING MOISTENING THE GOLD TIP OF THE COIL AND ROTATING THE CONTROLLER TO FACILITATE RELEASE. DESPITE THESE EFFORTS, THE AUDIBLE RELEASE SIGNAL WAS NOT HEARD ON ANY ATTEMPT, AND THE INDICATOR LIGHT CHANGED FROM GREEN TO ORANGE WITHOUT CONFIRMING DEPLOYMENT. IT WAS REPORTED THAT UNDER FLUOROSCOPIC GUIDANCE, THE COIL WAS CONFIRMED NOT TO HAVE RELEASED. THE PHYSICIAN PROCEEDED TO REMOVE THE SYSTEM, AND THROUGH COUNTER-TRACTION, THE COIL DETACHED WHILE REMAINING WITHIN THE MICROCATHETER. THE COIL WAS THEN POSITIONED WITHIN THE ANEURYSM USING ADVANCEMENT MANEUVERS WITH THE PUSHER, WHERE IT WAS ULTIMATELY IMPLANTED. THERE WAS NO PATIENT INJURY. IT IS INDICATED THAT THE PATIENT WAS IN GOOD CLINICAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24540365 ↗
• MalfunctionMar 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE COIL EXIT MARKER LOCATED ON THE PUSHER OUTSIDE OF THE PATIENT WAS NOT IN THE CORRECT LOCATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579925 ↗
• MalfunctionNov 14, 2019Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM, THE COIL STRETCHED AND DETACHED DURING REPOSITIONING. THE IMPLANT WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325402 ↗
• InjuryOct 10, 2018Difficult to Remove; Separation Failure; Detachment of Device or Device Component; Difficult to Remove; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EMBOLIZATION COIL DID NOT DETACH. DURING THE ATTEMPT TO REMOVE THE COIL, IT STRETCHED AND DETACHED. THE COIL WAS REMOVED SUCCESSFULLY WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE ISSUE. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954391 ↗