MicroPlex VFC VFC061030-V (UDI 00810170016233)Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 13, 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 00810170016233), received between Apr 19, 2019 and Apr 19, 2019 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Difficult or Delayed Positioning1
- Difficult to Remove1
Patient problems
- Paresis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2019Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component; Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component
ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2019: THERE WAS ONLY ONE IMMEDIATE ATTEMPT TO PUSH THE COIL IN THE ANEURYSM; HOWEVER, IT WAS CLEAR IMMEDIATELY THAT THIS WOULD NOT WORK. THE SNARE WAS INSERTED WITHIN 5 MIN. AFTER TRYING TO CATCH THE COIL FOR ABOUT 8 MIN, THE SNARE WAS RETRACED AND THE STENT RETRIEVER INSERTED. AFTER APPROXIMATELY 10 MINUTES, THE COIL COULD BE FIXED IN THE GUIDING CATHETER AND, AND COMPLETELY EXTRACTED. IN THE CONTROL ANGIOGRAM, NO VESSEL OCCLUSION WAS OBSERVED; HOWEVER, THE SMALL VESSELS THAT WERE AFFECTED DUE TO THE MRI AFTER THE PROCEDURE, CANNOT BE DETECTED IN AN ANGIOGRAM. AS WE DID NOT OBSERVE A THROMBUS AFTER RETRACTION, NO FURTHER MEDICATION WAS GIVEN AT THIS POINT. THE PATIENT WAS UNDER ASPIRIN AND PLAVIX AS A 2ND STENT (TO THE ONE THAT WAS INSIDE SINCE 2 YEARS) MIGHT HAVE BEEN NECESSARY IN THIS PROCEDURE. AT THE END THE SECOND STENT WAS NOT NEEDED. AT THE END OF THE PROCEDURE, THERE WAS THROMBUS FORMATION AT THE ANEURYSM BASE, AND AFTER 2.5 HRS AFTER THE COIL RETRACTION, 20 MG REOPRO WWAS GIVEN OVER THE GUIDING CATHETER. THE ANEURYSM IS COMPLETELY OCCLUDED NOW. THE PATIENT RECOVERED FROM THE SLIGHT ARM AND LEG PARESIS, AND IS AT
Patient problems: Paresis
MAUDE report 8533090 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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