ORBIT GALAXY 640CR1430Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=14mm 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 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 10886704030492), received between Nov 1, 2023 and Nov 1, 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 18, 2026.
Reports received per month
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.
MalfunctionNov 1, 2023Premature Separation; Premature Separation
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 14MM X 30CM ORBIT GALAXY COMPLEX FRAME (640CR1430 / 30711252) WAS ADVANCING IN THE MICROCATHETER (UNSPECIFIED BRAND) TO DEPLOY AT THE TARGET SITE, BUT THE COIL BECAME DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED. THE PROCEDURE WAS REPORTED TO BE SUCCESSFULLY COMPLETED. THERE WAS A 5-MINUTE DELAY. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 26-OCT-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THE PROCEDURE WAS ANEURYSM COILING. THE TARGET LESION WAS A 17MM CAROTID CAVERNOUS FISTULA (CCF). THE EMBOLIC COIL DID NOT PREMATURELY DETACH AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT. THE MICROCATHETER USED WAS A SL-10® MICROCATHETER (STRYKER). THE REPORTED EVENT DID NOT RESULT IN ANY REDUCED / RESTRICTED BLOOD FLOW IN THE PARENT VESSEL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT COIL. THE PHYSICIAN DID NOT CONSIDER THE 5-MINUTE DELAY TO BE CLINICALLY SIGNIFICANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18049362 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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