ORBIT GALAXY 640CR1030Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=10mm 30cm Contents:1 Detachable Coil System with Tight Distal Loop technology and 1 luer valve. Coil Type: Complex Frame Note: ONLY use with TRUFILL DCS Syringe II. · Class 2
All models of ORBIT GALAXY (26)
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 10886704030478), received between Apr 21, 2023 and Apr 21, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2023Premature Separation; Premature Separation
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THAT THE COMPLAINT COIL, A 10MM X 30CM ORBIT GALAXY COMPLEX FRAME COIL (640CR1030 / 30683888) BECAME DETACHED IN THE CONCOMITANT MICROCATHETER, A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30723358). THE FULL ASSEMBLY WAS REMOVED ALONG WITH THE MICROCATHETER. IT WAS REPORTED THAT FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY WITHOUT INTERVENTION. THERE WAS NO PROCEDURE DELAY DUE TO THE REPORTED ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16792389 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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