MicroPlex Helical Soft 100308HCSR-S-VRecalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of MicroPlex Helical Soft (9)
Data updated Oct 16, 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 00811425024973), received between Aug 22, 2016 and Aug 22, 2016 — classified as 1 malfunction.
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
- Device Issue1
Patient problems
- Aneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2016Break; Device Issue; Detachment of Device or Device Component; Break; Device Issue; Detachment of Device or Device Component
IT WAS REPORTED FROM (B)(6) THAT DURING THE TREATMENT OF AN ANEURYSM AT THE VERTEBRAL ARTERY, UPON ADVANCEMENT OF THE COIL, RESISTANCE WAS ENCOUNTERED. AS THE DEVICE WAS WITHDRAWN, THE DELIVERY PUSHER WAS REPORTED TO BREAK. THE COIL WAS REMOVED WITH THE CATHETER WITHOUT INCIDENT. ADDITIONAL COILS WERE DEPLOYED SUCCESSFULLY. NO INTERVENTION WAS TAKEN. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.
Patient problems: Aneurysm
MAUDE report 5895107 ↗
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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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