MICRUSPHERE SSR100514-20Recalls & reported problems
Medos International Sàrl · MICRUSPHERE XL microcoil MICRUSPHERE XL 10 Stretch Resistant Coil 5mm x 14cm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528009931), received between Apr 3, 2018 and Jun 13, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Stretched” (2 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, 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
- Stretched2
- Material Twisted/Bent1
- Positioning Failure1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent
AS REPORTED BY A HEALTHCARE PROFESSIONAL, A 5MM X 14CM MICRUSPHERE XL (SSR10051420/ P11333) WAS UNABLE TO ADVANCE BEYOND 1/3 OF THE UNSPECIFIED MICROCATHETER AND THE COIL INTRODUCER PROTRUDED THROUGH THE SIDE OF THE DELIVERY SYSTEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8697827 ↗MalfunctionApr 3, 2018Positioning Failure; Stretched; Positioning Failure; Stretched
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE FOR AN ANEURYSM AT THE MIDDLE CEREBRAL ARTERY, THE PHYSICIAN DEPLOYED THE MICRUSPHERE XL 5 MM X 14 CM (SSR10051420 / S14107) THROUGH A STRYKER SL-10 MICROCATHETER. THE COIL FORMED A GOOD BASKET INSIDE THE ANEURYSM. WHEN THE PHYSICIAN CONNECTED THE DETACHMENT CABLE AND PRESSED THE BUTTON ON THE DETACHMENT CONTROL BOX, THE COIL DID NOT DETACH. SEVERAL ATTEMPTS WERE MADE BUT THE COIL FAILED TO DETACH. THE PHYSICIAN REMOVED THE COIL AND DEPLOYED ANOTHER 5X14 MICRUSPHERE AND THE SUCCESSFULLY DETACH THE COIL ON THE FIRST ATTEMPT USING THE SAME DETACHMENT CABLE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7394668 ↗
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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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