V-Trak 100310HCSR-S-V-A2Recalls & reported problems
Microvention, Inc. · MicroPlex Helical Soft · Class 2 · Implant
All models of V-Trak (75)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777020390), received between Aug 2, 2023 and Aug 2, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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 18, 2026.
Most reported problems
Device problems
- Migration1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 2, 2023Unraveled Material; Migration; Unraveled Material; Migration
IT WAS REPORTED THAT DURING TREATMENT TO EMBOLIZE AN ANEURYSM IN THE MCA, THE COIL WAS DEPLOYED USING THE DETACHMENT CONTROLLER AND APPEARED DETACHED HOWEVER, UPON WITHDRAW OF THE DELIVERY PUSHER, IT WAS OBSERVED THE COIL WAS STUCK WITHIN THE DISTAL END OF THE MICROCATHETER. DURING THE RETRIEVAL OF THE PUSHER AND COIL, THE COIL MOVED FROM THE ANEURYSM AND UNRAVELED WHILE REMAINING PARTIALLY IN THE ANEURYSM AND VESSEL. THE MICROCATHETER WAS REMOVED WITH THE DELIVERY PUSHER. ANOTHER MICROCATHETER WAS USED TO DELIVER ADDITIONAL EMBOLIZATION COILS SUCCESSFULLY. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17447156 ↗
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- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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