V-Trak 7110-0415-A2Recalls & reported problems
Microvention, Inc. · HydroFrame 10 Advanced · Class 2 · Implant
All models of V-Trak (75)
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 00816777025258), received between Dec 20, 2019 and Mar 12, 2021 — classified as 1 injury, 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. 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 Component1
- Difficult or Delayed Separation1
- 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.
MalfunctionMar 12, 2021Stretched; Difficult or Delayed Separation; Stretched; Difficult or Delayed Separation
IT WAS REPORTED THAT DURING TREATMENT OF A RUPTURED ANEURYSM, AN EMBOLIZATION COIL IMPLANT DID NOT DETACH. IT THEN STRETCHED, AND A PORTION OF THE STRETCHED COIL REMAINS IMPLANTED IN THE PATIENT. IT WAS THE PHYSICIAN'S OPINION THAT THE STRETCHED SEGMENT WOULD NOT BE "A MAJOR CONTRIBUTING ISSUE FOR THE OUTCOME OF THE PATIENT." THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT'S CURRENT STATUS IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11478453 ↗InjuryDec 20, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING STENT-ASSISTED COILING OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, AN EMBOLIZATION COIL IMPLANT WOULD NOT DETACH. WHEN THE COIL WAS BEING REMOVED, IT UNEXPECTEDLY DETACHED AND SOME OF THE COIL EXTENDED INTO THE PARENT VESSEL. ANOTHER STENT WAS IMPLANTED TO AFFIX THE COIL TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE DOING WELL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9508112 ↗
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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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