MICRUSPHERE SSR100225-20Recalls & reported problems
Medos International Sàrl · MICRUSPHERE XL microcoil MICRUSPHERE XL 10 Stretch Resistant Coil 2mm x 2.5cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant
All models of MICRUSPHERE (22)
Data updated Oct 16, 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 00878528009757), received between Oct 17, 2016 and Oct 17, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult To Position” (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 16, 2026.
Most reported problems
Device problems
- Difficult To Position1
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.
MalfunctionOct 17, 2016Difficult To Position; Difficult To Position
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE THE PHYSICIAN TRIED TO DEPLOY A MICRUSPHERE XL 2MM X 2.5CM COIL (SSR10022520/C25653); HOWEVER THE MICROCATHETER (COMPETITORDEVICE/TYPE UNKNOWN) FACED STIFF RESISTANCE AND THE COIL DID NOT LOOP PROPERLY INSIDE THE ANEURYSM, NOT CONFORMING TO THE WALLS OF ANEURYSM AND AFTER A FEW LOOPS THE CATHETER KICKED OUT. THE COIL WAS RE-SHEATHED AND REMOVED WITHOUT ANY DIFFICULTY. THE PHYSICIAN USED A GALAXY COIL INSTEAD AND IT DEPLOYED WITHOUT ANY ISSUES. THE PROCEDURE WAS COIL EMBOLIZATION OF MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS RELATED TO THE DEVICE OR THE REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6034125 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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