MicroPlex Helical Regular 180830HC-R-VRecalls & reported problems
Microvention, Inc. · V-Trak · Class 2
Data updated Oct 13, 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 00811425025994), received between Mar 1, 2019 and Mar 1, 2019 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL IN THE MICROCATHETER. DURING REMOVAL, THE PUSHER DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8382529 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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