MICRUSPHERE SSR100510-20Recalls & reported problems
Medos International Sàrl · MICRUSPHERE XL microcoil MICRUSPHERE XL 10 Stretch Resistant Coil 5mm x 10cm 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 00878528009801), received between Nov 22, 2016 and Nov 22, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Knotted” (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
- Knotted1
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.
MalfunctionNov 22, 2016Knotted; Knotted
AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE AFTER 3 FAILED ATTEMPTS TO USE THE MICRUSPHERE XL 5MM X 10 CM COIL (SSR10051020/C28152) IN THE PATIENT THEY DISCOVERED THAT THERE WAS A KNOT ON THE COIL. THE PROCEDURE WAS COMPLETED WITH A SAME LIKE PRODUCT. THERE WERE NO ADVERSE EVENTS. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6121936 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page