MicroPlex Helical Regular 100730HC-R-VRecalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170010200), received between Aug 9, 2019 and Mar 18, 2022 — classified as 1 injury, 1 malfunction.
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
Device problems
- Detachment of Device or Device Component2
- Device-Device Incompatibility1
- Separation Failure1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2022Stretched; Separation Failure; Detachment of Device or Device Component; Stretched; Separation Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WOULD NOT DETACH COMPLETELY FROM THE DELIVERY PUSHER. AFTER THE DETACHMENT ATTEMPT, THE DELIVERY PUSHER APPEARED ATTACHED TO THE IMPLANT. DURING REMOVAL, THE IMPLANT DETACHED. INTERVENTION WAS TAKEN TO REMOVE THE COIL IN THE FORM OF A LOOP MANEUVER. THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13807048 ↗MalfunctionAug 9, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT DURING EMBOLIZATION OF AN ANEURYSM OF THE LEFT MIDDLE CEREBRAL ARTERY, AN EMBOLIZATION COIL ENCOUNTERED FRICTION DURING ADVANCEMENT IN THE MICROCATHETER. DURING REMOVAL OF THE DEVICE FROM THE MICROCATHETER, THE IMPLANT COIL STRETCHED AND BROKE. THE DEVICE WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8881259 ↗
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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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