V-Trak 7210-0152-A2Recalls & reported problems
Microvention, Inc. · HydroSoft Advanced · Class 2 · Implant
All models of V-Trak (75)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777023025), received between Nov 7, 2018 and Nov 7, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Neuropathy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN UNEVENTFUL BALLOON ASSISTED COILING PROCEDURE FOR A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM WAS PERFORMED ON A PATIENT THAT PRESENTED WITH SUDDEN HEADACHE, REDUCED CONSCIOUS LEVEL, AND SUBARACHNOID HEMORRHAGE. POST PROCEDURE, THE PATIENT WOKE UP WITH IPSILATERAL 3RD NERVE PALSY. THE CONDITION DID NOT IMPROVE WITH A SHORT COURSE OF STEROIDS, AND THE PATIENT UNDERWENT NEUROSURGICAL NERVE DECOMPRESSION TWO (2) DAYS LATER, WHICH WAS BELIEVED TO BE A RESULT OF AN IMMEDIATE MASS EFFECT OF THE COILED ANEURYSM ON THE 3RD NERVE. THE PATIENT IS ENROLLED IN A POST-MARKET CLINICAL TRIAL.
Patient problems: Neuropathy
MAUDE report 8049352 ↗
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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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