HydroFrame Framing Coil 181139HFRM-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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777023827), received between May 8, 2019 and Mar 17, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Device-Device Incompatibility1
- Difficult to Remove1
- 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.
InjuryMar 17, 2021Difficult to Remove; Separation Failure; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Separation Failure; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE COIL DID NOT DETACH. THE COIL BECAME STUCK IN THE MICROCATHETER UPON WITHDRAWL AND THE DELIVERY PUSHER BROKE. THE DEVICE WAS SUCCESSFULLY REMOVED WITH A SNARE AFTER APPROXIMATELY TWO AND A HALF HOURS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11509977 ↗InjuryMay 8, 2019Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component
IT WAS REPORTED THAT SEVERAL COILS WERE SUCCESSFULLY IMPLANTED IN AN ANEURYSM AFTER A NON MV STENT WAS DEPLOYED. ANOTHER COIL WAS DEPLOYED PARTIALLY IN THE CATHETER AND PARTIALLY IN THE ANEURYSM WHEN THE PHYSICIAN DECIDED TO RE-POSITION THE CATHETER, CAUSING THE COIL TO STRETCH. DURING REMOVAL, THE COIL DETACHED FROM THE PUSHER WIRE. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL WITH A SNARE DEVICE; HOWEVER, WAS UNSUCCESSFUL. THE COIL WAS SUCCESSFULLY REMOVED WITH A STENT RETRIEVER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE DOING OKAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8593172 ↗
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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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