ORBIT GALAXY 640CF0610Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=6mm 10cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Fill Note: ONLY use with TRUFILL DCS Syringe II. · Class 2
- 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 10886704030324), received between Feb 10, 2026 and Feb 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Separation Failure1
- Stretched1
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.
MalfunctionFeb 10, 2026Stretched; Separation Failure
DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2025, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE 8MM X 24CM ORBIT GALAXY COMPLEX FILL (640CF0824 / 31234521) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A SECOND COIL, A 6MM X 10CM ORBIT GALAXY COMPLEX FILL (640CF0610 / 31226101). THE SECOND COIL ENCOUNTERED THE SAME ISSUE; UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE SECOND COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURER AND COMPLETED THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THE PROCEDURE WAS PROLONGED BY ABOUT 15 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 09-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL OF THE PROCEDURE WAS THE POSTERIOR CEREBRAL ARTERY. PER THE INFORMATION, BOTH COILS WERE STRETCHED WHEN THEY WERE REMOVED; BOTH WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. THERE WAS NO EVIDENCE OF OBSTRUCTED / REDUCTION OF BLOOD FLOW DUE TO THE REPORTED ISSUE. THE SYRINGE WAS FILLED WITH SALINE FROM A DED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306510 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.