MICRUSPHERE CERECYTERecalls & reported problems across all models

We found 8 models of MICRUSPHERE CERECYTE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2016 and Dec 17, 2020 — classified as 16 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Stretched” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MICRUSPHERE CERECYTE problems

MICRUSPHERE CERECYTE models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MICRUSPHERE CERECYTE CSP100250-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• MICRUSPHERE CERECYTE CSP100300-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• MICRUSPHERE CERECYTE CSP100350-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• MICRUSPHERE CERECYTE CSP100400-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• MICRUSPHERE CERECYTE CSP100500-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• MICRUSPHERE CERECYTE CSP100200-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• MICRUSPHERE CERECYTE CSP100600-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• MICRUSPHERE CERECYTE CSP100700-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent MICRUSPHERE CERECYTE adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 13, 2019Stretched; Material Deformation; Stretched; Material Deformation

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION, THERE WAS RESHEATING FAILURE WITH A MSPHERE 10 CERE COIL (CSP10025030, UNKNOWN LOT). THERE WAS NO REPORT OF PATIENT INJURY. PER FAILURE ANALYSIS, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696065 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 7, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 6MM X 11.9CM MICRUSPHERE 10 (CSP10060030/S11270) COIL STRETCHED DURING THE PROCEDURE. IT IS NOT REPORTED IF THE COIL WAS REMOVED EASILY FROM THE PATIENT WITHOUT THE NEED FOR ADDITIONAL INTERVENTION; HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO FRAGMENTS WERE GENERATED. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316892 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 13, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE COIL INTRODUCER OF THE 2.5MM X 3.3CM MICRUSPHERE 10 CERECYTE THERMO-MECHANICAL DETACHABLE COIL SYSTEM (CSP10025030/UNKNOWN LOT) WAS BROKEN AND THE INTRODUCER TIP OF THE 2MM X 3CM DELTAPAQ 10 CERECYTE (CDF10020330/UNKNOWN LOT) WAS BLOCKED. THE ENPOWER DETACHMENT CONTROL BOX (DCB) TEST LAMP WAS NOT ON DURING PRE-TEST OF THE 2MM X 2.5 CM MICRUSPHERE 10 CERECYTE (CSP10020030/UNKNOWN LOT) AND THE 2MM X 6CM DELTAPAQ 10 CERECYTE (CDF10020630/UNKNOWN LOT). ABNORMAL FRICTION WAS ENCOUNTERED WITH THE COIL AND INTRODUCER OF THE 4MM X 7.5 CM MICRUSPHERE 10 CERECYTE (CSP10040030/UNKNOWN LOT). IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS ANY PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7336560 ↗
• 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 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) 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 RECUR

  Patient problems: Aneurysm; Reaction

  MAUDE report 6649301 ↗

Other Medos International Sàrl products

• TRUESPAN ORTHOCORD6 models · 4,109 reports
• FMS39 models · 3,588 reports
• EXPEDIUM291 models · 3,312 reports
• EXPEDIUM VERSE90 models · 2,686 reports
• EXPRESSEW6 models · 2,459 reports
• OMNISPAN ORTHOCORD3 models · 1,581 reports
• HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
• PROWLER SELECT9 models · 1,066 reports