MICRUSPHERE CERECYTE CSP100350-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878528001034), received between Jun 17, 2017 and Nov 25, 2019 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 3.5MMX6.6CM MSPHERE 10 CERE COIL (CSP10035030, S14654) COULDN¿T BE DETACHED. THE PHYSICIAN FOUND THE PROBLEM WITH GREEN LIGHT NOT WORKING AND CHANGED THE DETACHED BOX AND CONNECTED THE LINE, TRIED AGAIN AND STILL FAILED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A COMPETITOR¿S COIL. NO PATIENT INJURY WAS REPORTED. THE COMPLAINT COIL WAS NOT IMPLANTED, IT WAS PULLED BACK INTO THE INTRODUCER. THERE WAS NO SIGNIFICANT PROLONGATION OF THE PROCEDURE DUE TO THE EVENT. A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED AND THERE WERE NO FAILURES IN THIS PROCESS. THE SAME DCB WAS USED WITH SUBSEQUENT COILS AND THE SAME CABLE WAS USED WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL WAS NOT STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE DEVICE WAS USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9368959 ↗
• MalfunctionOct 3, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 3.5MMX6.6CM MSPHERE 10 CERE COIL (CSP10035030,C39791) WAS BEING USED AS THE FIRST COIL, HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNKNOWN MICROCATHETER 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 REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152083 ↗
• 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

  Patient problems: Aneurysm; Reaction

  MAUDE report 6649300 ↗
• 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 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 ANEURY

  Patient problems: Aneurysm; Reaction

  MAUDE report 6649294 ↗
• 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 RE

  Patient problems: Aneurysm; Reaction

  MAUDE report 6649291 ↗