MICRUSPHERE SSR181840-20Recalls & reported problems
Medos International Sàrl · MICRUSPHERE XL microcoil MICRUSPHERE XL 18 Stretch Resistant Coil 18mm 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 00878528009993), received between Jul 31, 2018 and Jul 31, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
- 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.
MalfunctionJul 31, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE MICRUSPHERE XL 18 STRETCH RESISTANT COIL 18 MM X 40 CM (SSR18184020 / S12635) WAS DEFECTIVE. ADDITIONAL INFORMATION RELATED TO THE TARGET VESSEL AND THE DETAILS REGARDING THE DEFECTIVE COIL WAS NOT AVAILABLE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7736588 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
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- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 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.
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