V-Trak 8410-0304-A2Recalls & reported problems
Microvention, Inc. · HyperSoft 3D Advanced · Class 2 · Implant
All models of V-Trak (75)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777021250), received between Jul 27, 2022 and Sep 8, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
Device problems
- Break1
- Detachment of Device or Device Component1
- Separation Failure1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING EMBOLIZATION OF THE COIL, IT WOULD NOT DETACH DESPITE MULTIPLE ATTEMPTS. PHYSICIAN THEN PULLED THE COIL BACK INTO THE CATHETER, WHILE DOING THIS THE COIL FINALLY DETACHED AND WENT OUT INTO THE VESSEL. THE COIL STRETCHED AND WAS LEFT IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS NO ISSUE WITH THE CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15383350 ↗MalfunctionJul 27, 2022Break; Separation Failure
DURING A CEREBRAL ANGIOGRAM, MICROPLEX10 3MM X 4MM COIL WAS USED IN THE LEFT INTERNAL CAROTID ARTERY. AT FIRST, THE COIL WOULD NOT DETACH. GOT NEW V GRIP TO ATTEMPT TO RELEASE COIL. TIP OF CATHETER THEN BROKE OFF IN THE PATIENT. BOX AND WIRE ITSELF IN IR FOR REVIEW IF NECESSARY. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 15121460 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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