MICRUSPHERE CERECYTE CSP100500-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528001058), received between Jun 17, 2017 and Nov 14, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 5MMX9.7CM MICRUSPHERE CERECYTE COIL (CSP10050030, C37249) WAS BEING USED AS THE FIRST COIL. WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE BEEPING SOUND WAS NORMAL BUT DURING RETRIEVING DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9321435 ↗
• MalfunctionJun 7, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH THE TARGET SITE ON THE INTERNAL CAROTID ARTERY (ICA) WHILE ATTEMPTING TO DETACH THE 5MM X 9.7CM MICRUSPHERE 10 CERECYTE COIL (CSP10050030 / S11237), THE ENPOWER DETACHMENT CONTROL BOX (DCB00000500 / C27718) DID NOT WORK PROPERLY AND THE COIL DID NOT DETACH. THE COIL WAS REMOVED STILL ATTACHED TO THE DELIVERY SYSTEM AND NOT STRETCHED. A PRE-DEPLOYMENT CHECK WAS PERFORMED AND THERE WAS NO ISSUE NOTED DURING THE CHECK. THERE WAS NO EVIDENCE OF LOW BATTERY, THE BOX HAD BEEN USED WITH PREVIOUS COILS; THE BOX HAD BEEN USED OVER THE LAST SEVERAL MONTHS WITHOUT ISSUE. THE COIL WAS REPLACED, AND THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE CUSTOMER CONTINUED TO USE THE DCB WITH THREE MORE COILS BECAUSE THEY HAD ASSUMED THE ISSUE WAS RELATED TO THE COILS AND NOT THE BOX. THE CUSTOMER REPLACED THE DCB AND DETERMINED THAT THE ENPOWER DETACHMENT CONTROL BOX DID NOT WORK PROPERLY AND RESULTED IN THE FAILED DETACHMENT OF THE COILS. THIS COIL AND THE OTHER THREE COILS WERE NOT RE-CHALLENGED AFTER THE DETACHMENT BOX WAS REPLACED. IT WAS REPORTED THAT THE COIL WAS DISCARDED ONCE IT WAS DETERMINED THAT THE ISSUE WAS WITH THE DCB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680269 ↗
• MalfunctionJan 14, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN DID NOT LIKE THE SHAPE OF COIL DEPLOYMENT OF THE 1.5MM X 2CM DELTAPAQ (CDF10015230/UNK LOT), 1.5MM X 3CM DELTAPLUSH 10 (CPL10015330/UNK LOT), AND THE 5MM X 9.7CM MICRUSPHERE 10 (CSP10050030/UNK LOT) AND DECIDED TO REMOVE THE COILS FROM THE PATIENT; HOWEVER, WHILE RESHEATHING THE COILS, THE INTRODUCERS FAILED TO BE REZIPPED. THE COIL WAS REPLACED WITH A SAME-LIKE COIL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. EVALUATION OF THE RETURNED MICRUSPHERE REVEALED KINKING AND STRETCHING OF THE EMBOLIC COIL. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246071 ↗
• InjuryJun 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE LITERATURE ARTICLE ¿ABNORMAL WHITE MATTER CHANGES AFTER CEREBRAL ANEURYSM TREATMENT WITH POLYGLYCOLIC-POLYLACTIC ACID COILS¿ BY LESLIE. SKOLARUS, JOSEPH J. GEMMETE, TIFFANY BRALEY, LEWIS B. MORGENSTERN, ADITYA PANDEY, PUBLISHED WORLD NEUROSURGERY, DOI:10.1016/J.WNEU.2010.03.026, IT WAS REPORTED THAT A FEMALE PATIENT HAD ANEURYSM RECANALIZATION AFTER INITIAL COILING WITH MICROSPHERE COILS (CSP10070030/F43069, CSP10035030/F40423, CSP10030030/F42941, CSP10050030/F44130, CSP10035030/F44304, CSP10030030/F42941, CSP10025030/F42083, CSP10025030/F43822, CSP10025030/F39589, CSP10035030/F44304, CSP10035030/F42085, CSP10030030/F44030 X 2, CSP10040030/F43624, CSP10040030/F42769), THEN HAD COIL COMPACTION AFTER THE SECOND COIL EMBOLIZATION WITH A MICROSPHERE COIL (CSP10060030/F44693), AND THEN HAD CEREBRAL LESIONS DEVELOP . PER THE ARTICLE, A (B)(6)-YEAR-OLD FEMALE SMOKER (CASE 2) SUFFERED A HUNT-HESS GRADE 3, FISHER GRADE 4 ANEURYSMAL SAH. CEREBRAL ANGIOGRAM REVEALED A 12 X 8-MM BASILAR TIP ANEURYSM. SHE UNDERWENT EMERGENT ENDOVASCULAR COILING ON (B)(6)2008 WITH IMPLANTATION OF 15 MICROSPHERE COILS, WHICH RESULTED IN GREATER THAN 90% ANEURYSM OBLITERATION. MRI SHOWED EVIDENCE OF ANEURYS

  Patient problems: Aneurysm; Reaction

  MAUDE report 6649295 ↗