MICRUSPHERE CERECYTE CSP100400-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528001041), received between Jun 17, 2017 and Dec 17, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2020Stretched; Failure to Advance; Difficult to Advance; Stretched; Failure to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 4MMX7.5CM MSPHERE 10 CERE COIL WAS BEING USED AS A FILLING COIL. HOWEVER, THE COIL WAS NOT ABLE TO ADVANCE NOR RETRIEVE BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11027382 ↗
• 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 4MM X 7.5CM MICRUSPHERE 10 CERECYTE COIL (CSP10040030 / S10465), 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 8680270 ↗
• 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 LESLI E. 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 MICRUSPHERE 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 MICRUSPHERE COIL (CSP10060030/F44693), AND THEN HAD CEREBRAL LESIONS DEVELOP. PER THE ARTICLE, A (B)(6) 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 MICRUSPHERE COILS, WHICH RESULTED IN GREATER THAN 90% ANEURYSM OBLITERATION. MRI SHOWED EVIDENCE OF ANEURYSM RECURR

  Patient problems: Aneurysm; Reaction

  MAUDE report 6649332 ↗
• 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 LESLI E. 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 MICRUSPHERE 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 MICRUSPHERE COIL (CSP10060030/F44693), AND THEN HAD CEREBRAL LESIONS DEVELOP . PER THE ARTICLE, A (B)(6) 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 MICRUSPHERE COILS, WHICH RESULTED IN GREATER THAN 90% ANEURYSM OBLITERATION. MRI SHOWED EVIDENCE OF ANEURYSM R

  Patient problems: Aneurysm; Reaction

  MAUDE report 6649289 ↗