ORBIT GALAXY 640CR1630Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=16mm 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704030508), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 injury.
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.
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.
InjuryNov 26, 2025Premature Separation; Premature Separation
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE FEMALE PATIENT WITH A RUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM MEASURING APPROXIMATELY 8MM X 12MM UNDERWENT AN ENDOVASCULAR COIL EMBOLIZATION TREATMENT ON (B)(6) 2025. THE PHYSICIAN USED A 6FR SHUTTLE® GUIDING SHEATH (COOK MEDICAL), A 125CM CEREGLIDE 71 INTERMEDIATE CATHETER, AND A STRAIGHT SL-10® MICROCATHETER (STRYKER) AS THE COILING MICROCATHETER. THE FIRST COIL WAS A 14MM X 30CM ORBIT GALAXY COMPLEX FRAME WAS PLACED INTO THE ANEURYSM AND DEPLOYED WITHOUT INCIDENT. THE COMPLAINT COIL WAS THE SECOND COIL, A 16MM X 30CM ORBIT GALAXY COMPLEX FRAME (640CR1630 / LOT# UNKNOWN), WAS ATTEMPTED TO BE PLACED INTO THE ANEURYSM, BUT THE PHYSICIAN DID NOT LIKE HOW IT WAS FITTING AND DECIDED TO REMOVE THE COIL AND MOVE ON TO ANOTHER SIZE. WHEN THE DETACHMENT SYSTEM OF THE 16MM X 30CM ORBIT GALAXY COMPLEX FRAME WAS REMOVED FROM THE PATIENT, THERE WAS NO COIL ATTACHED TO THE SYSTEM. FLUOROSCOPY SHOWED THAT THE COIL WAS STILL HALFWAY IN THE ANEURYSM AND HALF IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE COIL WAS NOT IN THE MICROCATHETER, IT WAS NOW IN THE CEREGLIDE 71 INTERMEDIATE CATHETER. THE PHYSICIAN WAS ABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660919 ↗
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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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