MICRUSPHERE SSR180825-20Recalls & reported problems
Medos International Sàrl · MICRUSPHERE XL microcoil MICRUSPHERE XL 18 Stretch Resistant Coil 8mm x 25cm 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 00878528009979), received between Jan 25, 2018 and Jun 4, 2021 — classified as 2 malfunctions.
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
- Separation Failure1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2021Separation Failure; Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, AN 8MM X 25CM MICRUSPHERE XL COIL (SSR18082520 / LOT# UNKNOWN) FAILED TO DETACH. THE PHYSICIAN REPLACED THE DETACHMENT CONTROL BOX (DCB) BUT THE COIL STILL WOULD NOT DETACH. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11942776 ↗MalfunctionJan 25, 2018Stretched; Physical Resistance; Stretched; Physical Resistance
DURING POSTERIOR COMMUNICATING ARTERY ANEURYSM COILING OF AN 8MM ANEURYSM, THE MICRUSPHERE XL COIL ((B)(4)/LOT UNK) GOT STUCK IN THE PROWLER LPES (LOT 17610383) MICROCATHETER, AND WHEN REMOVED, IT WAS STRETCHED. THE PATIENT HAD PRESENTED WITH A SUBARACHNOID HEMORRHAGE, SEVERE HEADACHE AND ¿PARALYSIS ATTACK¿. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND PRIOR TO THIS COIL 2 COILS HAD GON THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THERE WERE NO KINKS IN THE MICROCATHETER. THE RESISTANCE WAS FELT DURING ADVANCEMENT THROUGH THE MICROCATHETER AND THE DEVICE HAD NOT EXITED THE DISTAL END OF THE MICROCATHETER INTO THE PATIENT. THERE WAS NO INJURY TO THE PATIENT; HOWEVER, THE PROCEDURE WAS DELAYED 10 TO 15 MINUTES DUE TO THE EVENT. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7218091 ↗
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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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