MicroPlex Cosmos 182263CS-VRecalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 16, 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 00810170014208), received between Dec 20, 2017 and Feb 16, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment Of 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 16, 2026.
Most reported problems
Device problems
- Detachment Of Device Component2
- Difficult To Position1
- Difficult to Remove1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- 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.
MalfunctionFeb 16, 2018Detachment Of Device Component; Difficult To Position; Detachment Of Device Component; Difficult To Position
IT WAS REPORTED THAT IT WAS DIFFICULT TO PLACE THE EMBOLIZATION COIL IN THE ANEURYSM. DURING REMOVAL, THE COIL DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY WITH THE MICROCATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7277411 ↗InjuryDec 20, 2017Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove
IT WAS REPORTED THAT DURING TREATMENT OF A GIANT BASILAR TIP ANEURYSM, THE COIL UNEXPECTEDLY DETACHED DURING IMPLANTATION. AN ATTEMPT WAS MADE TO REMOVE THE COIL WITH A SNARE DEVICE; HOWEVER, IT WAS NOT SUCCESSFUL. THE COIL WAS IMPLANTED PARTIALLY IN THE ANEURYSM AND DOWN INTO THE BASILAR ARTERY. SOMETIME AFTER THE PROCEDURE, THE PATIENT EXPERIENCED BLEEDING AND IS RECEIVING ONGOING TREATMENT. THE PATIENT WAS ALSO TREATED FOR VASOSPASM. IT WAS STATED THAT THIS PROCEDURE WAS THE THIRD ATTEMPT TO TREAT THE PATIENT, AND IT WAS A CHALLENGING CASE. IT IS UNKNOWN IF THERE WAS A RELATIONSHIP BETWEEN THE COIL AND THE PATIENT BLEED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 7135859 ↗
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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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