MicroPlex Cosmos 182468CS-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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170014222), received between Apr 7, 2017 and Nov 16, 2021 — classified as 2 malfunctions.
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
- Detachment of Device or Device Component1
- Difficult To Position1
- Difficult to Remove1
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.
MalfunctionNov 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE PUSHER DETACHED IN THE MICROCATHETER. THE DEVICES WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND A NEW SET WAS USED TO COMPLETED THE CASE. THERE WAS NO HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12824897 ↗MalfunctionApr 7, 2017Detachment Of Device Component; Difficult To Position; Difficult to Remove; Detachment Of Device Component; Difficult To Position; Difficult to Remove
IT WAS REPORTED THAT COIL EMBOLIZATION TREATMENT WAS PERFORMED FOR A CAVERNOUS ICA ANEURYSM. POSITIONING THE COIL WAS DIFFICULT, SO AN ATTEMPT WAS MADE TO REMOVE THE COIL. DURING THE WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AND THEN THE COIL DETACHED. NO INTERVENTION WAS PERFORMED AND THE COIL REMAINS IMPLANTED IN THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS CURRENTLY REPORTED TO BE DOING WELL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6474421 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page