MICRUSPHERE CERECYTE CSP100200-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528001003), received between Dec 14, 2018 and Mar 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2MM X 2.5CM MICRUSPHERE 10 CERECYTE COIL (CSP10020030 / S10462) WAS THE FIRST COIL USED IN THE PROCEDURE; IT WAS REPORTED THAT THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 2MM X 2.5CM MICRUSPHERE 10 CERECYTE COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836623 ↗
• MalfunctionDec 14, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT STRONG RESISTANCE WAS ENCOUNTERED DURING THE ADVANCEMENT OF THE 2MM X 2.5CM MICRUSPHERE 10 CERECYTE COIL (CSP10020030 / S11413) THROUGH THE PROWLER LPES MICROCATHETER. THE PHYSICIAN REPLACED THE COIL WITH ANOTHER MICRUSPHERE 10 CERECYTE COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND DETAILS RELATED TO THE PROCEDURE, HOWEVER, ADDITIONAL INFORMATION WAS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8165076 ↗