V-Trak 7210-0308-A2Recalls & reported problems
Microvention, Inc. · HydroSoft Advanced · Class 2 · Implant
All models of V-Trak (75)
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 00816777023148), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 injury.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE, THE TWO COILS UNINTENTIONALLY DETACHED FROM THE PUSHER IN THE MICROCATHETER DURING MANIPULATION INTO A LARGE ANEURYSM. THE PHYSICIAN USED A SNARE DEVICE TO REMOVED THE ENTIRE COILS FROM THE PATIENT. THE PATIENT HAD SEVERAL COMPLICATIONS UNRELATED TO THE COILS. THE PATIENT CURRENT STATUS IS STABLE. THIS REPORT 1 OF 2. REFERENCE MFR. REPORT# 2032493-2022-00056.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13536856 ↗
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- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
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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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