V-Trak 7110-1036-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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777023766), received between Oct 11, 2022 and Jun 30, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (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.
Reports received per month
Most reported problems
Device problems
- Unraveled Material2
- Detachment of Device or Device Component1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2026Unraveled Material
AS REPORTED: THE COIL STRETCHED AND UNWOUND AND NEEDED TO BE TACKED DOWN WITH A STENT. DURING RECAPTURE AND TRYING TO REPOSITION MULTIPLE TIMES THE COIL BECAME COMPROMISED OR DAMAGED AND WHEN PULLED BACK INTO MICROCATHETER STRETCHED. ATTEMPTS WERE MADE TO REMOVE BUT WOULD HAVE CAUSED DISRUPTION OF COIL MASS SO DECISION WAS MADE TO LEAVE. FOLLOW UP SHOWED NO IMMEDIATE ISSUE OR COMPLICATION. PHYSICIAN WILL DUE FOLLOW UP IN 6 MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673262 ↗InjuryMay 19, 2026Unraveled Material; Premature Separation
AS REPORTED: EMBOLIZATION COIL UNRAVELED AND BROKE APART, IS RETAINED INSIDE THE LEFT ICA OF PATIENT.
Patient problems: Insufficient Information
MAUDE report 25219921 ↗MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, TWO (2) CONSECUTIVE COILS DID NOT FIT THROUGH THE MICROCATHETER. BOTH COILS STARTED TO CATCH IN THE LUMEN AND DETACHED IN THE CATHETER PRIOR TO USE OF THE CONTROLLER. THE COILS WERE REMOVED IN ONE PIECE, AND ADDITIONAL COILS WERE USED FOR THE REMAINDER OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15580746 ↗
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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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