ORBIT GALAXY 640CR2030Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=20mm 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 10886704030522), received between Jul 31, 2025 and Jul 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Advance1
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.
MalfunctionJul 31, 2025Failure to Advance; Failure to Advance
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, AFTER ABOUT HALF OF THE 20MM X 30CM ORBIT GALAXY COMPLEX FRAME COIL (640CR2030 / 31122650) WAS FILLED IN THE ANEURYSM, THE COIL WAS FOUND TO BE IMPEDED IN THE CONCOMITANT MICROCATHETER TIP AND COULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH ANOTHER 20MM X 30CM ORBIT GALAXY COMPLEX FRAME COIL (640CR2030 / 31122650) AND DELIVERED THIS SECOND COIL, BUT THE SAME ISSUE WAS ENCOUNTERED; THE COIL ALSO BECAME IMPEDED IN THE MICROCATHETER. THE PHYSICIAN RETRACTED THIS COIL AND REPLACED IT WITH ANOTHER COIL (COMPETITOR BRAND) TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER (COMPETITOR BRAND). THE PROCEDURE WAS PROLONGED BY ABOUT 30 MINUTES BUT WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 01-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET VESSEL WAS THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THERE WAS CIRCUMFLEXION OF THE ICA PROXIMAL TO THE BLOOD VESSELS. THE CONCOMITANT MICROCATHETER WAS AN ECHELON¿ 14 MICROCATHETER (MEDTRONIC). NO OTHER DEVICES PASSED THROUGH THE MIC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22683563 ↗
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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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