HydroFrame Framing Coil 181644HFRM-V-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 18, 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 00816777023872), received between Jun 30, 2021 and Oct 24, 2025 — classified as 1 injury, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2025Break; Separation Failure; Break; Separation Failure
AS REPORTED, THE COIL WAS IMPLANTED VIA A JAILED HEADWAY 17 AND FLOW DIVERTER. THE DETACHMENT CONTROLLER SHOWED GREEN HOWEVER, DID NOT SOUND CORRECT FOR DETACHMENT CONFIRMATION. IT WAS THOUGHT THE COIL WAS DETACHED BUT IT SHOWED THAT THE PUSHER WIRE HAD BROKEN AND SEPARATED. THE IMPLANT COIL REMAINED ATTACHED TO THE DELIVERY PUSHER. THE BROKEN PUSHER WIRE AND THE COIL WERE REMOVED FROM THE PATIENT WITH A GUIDEWIRE AND MANIPULATION WITHIN THE MICROCATHETER. THE CASE WAS COMPLETED WITH FLOW DIVERTER ONLY AS JAILED MICROCATHETER WAS REMOVED WITH THE COIL SYSTEM. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23382027 ↗MalfunctionJun 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT AN EMBOLIZATION COIL UNEXPECTEDLY DETACHED DURING DEPLOYMENT IN AN ACUTE BASILAR TIP ANEURYSM PROCEDURE. A SNARE DEVICE WAS USED TO SUCCESSFULLY RETRIEVED THE COIL. THERE WAS NO REPORT OF INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12096662 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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