ORBIT GALAXY 640CF1230Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=12mm 30cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Fill Note: ONLY use with TRUFILL DCS Syringe II. · Class 2
Data updated Oct 13, 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 10886704030423), received between Jan 28, 2026 and Jan 28, 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
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.
MalfunctionJan 28, 2026Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A 12X30 ORBIT GALAXY COIL (PRODUCT CODE 640CF1230, LOT NUMBER 31613399) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE NON J&J MICROCATHETER (MC) WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-JAN-2026 INDICATED THAT THE SYRINGE USED WAS A JOHNSON & JOHNSON PRODUCT. THE SAME SYRINGE WAS USED TO DETACH SUBSEQUENT COILS. THE SAME SYRINGE WAS PREVIOUSLY EXCEEDED THE GREEN ZONE/POSITION 3. AFTER THE COIL DID NOT DETACH AT THE SYRINGE GREEN ZONE, IT WAS ATTEMPTED TO DEPLOY THE COIL AT THE SYRINGE RED ALTERNATIVE DETACHMENT ZONE. PRIOR TO ATTEMPTING TO DETACH, IT WAS VERIFIED UNDER FLUORO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR DELIVERY TUBE. THE SYRINGE PRESSURIZED AS INTENDED. NECK REMODELING WAS UTILIZED WITH A STENT. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WERE NO PROCEDURE DELAYS/PROLONGATION DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199347 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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