MICRUSPHERE CERECYTE CSP100300-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878528001027), received between Oct 14, 2016 and Jun 17, 2017 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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.

• 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 6649302 ↗
• 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) 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 9/6/2008 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 6649296 ↗
• 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 6649293 ↗
• 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 6649290 ↗
• MalfunctionOct 14, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION, THE MICRUSPHERE (CSP10030030/ C38744) COULD NOT BE DETACHED. THEY WITHDREW THE COIL AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6031748 ↗