MICRUSPHERE SSR181640-20Recalls & reported problems
Medos International Sàrl · MICRUSPHERE XL microcoil MICRUSPHERE XL 18 Stretch Resistant Coil 16mm x 40cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of MICRUSPHERE (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528009856), received between May 19, 2017 and May 19, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance” (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 18, 2026.
Most reported problems
Device problems
- Physical Resistance1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2017Stretched; Physical Resistance; Stretched; Physical Resistance
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSPHERE COIL (SSR18164020/ C24003) GOT STUCK IN THE MID PORTION OF THE MICROCATHETER (ECHELON 10, MEDTRONIC PRODUCT) AFTER INSERTION THROUGH THE HUB AND FOUND TO BE STRETCHED WHEN IT WAS REMOVED FROM THE MICROCATHETER DURING AN ANEURYSM COILING PROCEDURE OF A CCF. BOTH THE MICROCATHETER AND THE MICRUSPHERE COIL (COMPLAINT PRODUCT) WERE REMOVED FROM THE PATIENT AT THIS TIME. STRYKER MEDTRONIC COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO THIS EVENT. THE PROCEDURE WAS COMPLETED WITH NON-CODMAN COILS. THE PATIENT WAS A MALE, AGE UNKNOWN WHO WAS REPORTED TO BE DOING WELL POST PROCEDURE. THE ANEURYSM HEIGHT WAS 20, WIDTH WAS 22, LENGTH WAS 18 AND NECK WAS 11. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THE PROCEDURE WAS DELAYED ABOUT 10 MINUTES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, NOR WAS ANY ADDITIONAL INTERVENTION REQUIRED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WERE NO KINKS NOTED ON THE MICROCATHETER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6578736 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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