MicroPlex Cosmos 182065CS-VRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810170014185), received between Apr 4, 2016 and Mar 29, 2022 — classified as 2 injuries, 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION IMPLANT COIL DETACHED UNEXPECTEDLY. THE IMPLANT WAS REMOVED WITHOUT THE NEED FOR INTERVENTION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935101 ↗
• InjuryApr 22, 2017Detachment Of Device Component; Difficult to Remove; Stretched; Detachment Of Device Component; Difficult to Remove; Stretched

  IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF A LARGE INTERNAL CAROTID ANEURYSM, AN ATTEMPT WAS MADE TO REMOVE THE FIRST IMPLANTED COIL; HOWEVER, DURING WITHDRAWAL OF THE COIL, THE COIL STRETCHED ALMOST DOWN TO THE COMMON CAROTID ARTERY AND THEN DETACHED AT THE DETACHMENT ZONE. THE PROXIMAL END OF THE DETACHED COIL WAS PUSHED UP INTO THE EXTERNAL CAROTID ARTERY. AN OCCLUSION BALLOON TEST HAD BEEN PERFORMED PRIOR TO THE PROCEDURE TO DETERMINE IF IT COULD BE AN OPTION FOR THE PATIENT AND IT WAS SUCCESSFUL; THEREFORE, THE DECISION WAS MADE TO TOTALLY OCCLUDE THE ICA. THE ANEURYSM WAS TREATED WITH ADDITIONAL COILS AND WHEN THE ANEURYSM WAS COMPLETELY OCCLUDED, THE COIL BALL MASS WAS BROUGHT BACK INTO THE ICA. FINALLY, TWO AMPLATZER PLUGS WERE DEPLOYED IN THE ICA PROXIMAL TO THE COIL MASS AND ANEURYSM. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELAE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6514323 ↗
• InjuryApr 4, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue

  IT WAS REPORTED FROM (B)(6) THAT DURING THE TREATMENT OF AN ANEURYSM, THE COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER WITHIN THE CATHETER DURING POSITIONING. THE COIL WAS PUSHED TO THE INTENDED SITE USING A WIRE SUCCESSFULLY. NO PATIENT HARM OR INJURY WAS REPORTED. THE PATIENT WAS REPORTED TO BE WELL WITH NO CLINICAL CONSEQUENCE.

  Patient problems: Aneurysm

  MAUDE report 5545173 ↗