MICRUSPHERE SSR181740-20Recalls & reported problems
Medos International Sàrl · MICRUSPHERE XL microcoil MICRUSPHERE XL 18 Stretch Resistant Coil 17mm x 40cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
Data updated Oct 13, 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 00878528009849), received between Aug 24, 2017 and Aug 24, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Premature Activation1
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.
MalfunctionAug 24, 2017Premature Activation; Premature Activation
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A CEREBRAL ANEURYSM, THE MICRUSPHERE XL COIL (SSR18174020/ S11164) DETACHED INSIDE THE PROWLER SELECT LPES MICROCATHETER (606S155FX/17423598) DURING INITIAL USE OF THE PRODUCT, AND BOTH DEVICES WERE REMOVED FROM THE PATIENT WITHOUT CAUSING ANY DAMAGE OR EXPOSING THE PATIENT TO RISK. NEW DEVICES OF THE SAME TYPE WERE OPENED FOR CONTINUITY OF THE SURGICAL PROCEDURE. THE DEVICES WERE DISCARDED BY THE CUSTOMER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6816342 ↗
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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