HydroFrame 18 Advanced 7118-2048Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
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 00811425029862), received between Apr 4, 2016 and Apr 4, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of 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 Component1
- Device Issue1
Patient problems
- Fistula1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue
IT WAS REPORTED THAT DURING THE TREATMENT OF A FISTULA, A PORTION OF THE COIL PREMATURELY DETACHED WITHIN THE CATHETER WHILE POSITIONING. THE REMAINDER OF THE COIL WAS PUSHED INTO THE INTENDED SITE SUCCESSFULLY. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: Fistula
MAUDE report 5545024 ↗
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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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