MICRUSPHERE CERECYTE CSP100700-30Recalls & reported problems
Medos International Sàrl · MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 7mm x 13.9cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of MICRUSPHERE CERECYTE (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528001072), received between Jun 17, 2017 and Jun 17, 2017 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Aneurysm1
- Reaction1
Recent adverse event reports
The 1 most recent of 1 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 RECUR
Patient problems: Aneurysm; Reaction
MAUDE report 6649301 ↗
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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