ORBIT GALAXY 640CF0815Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=8mm 15cm 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 10886704030379), received between Jul 31, 2026 and Jul 31, 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.
MalfunctionJul 31, 2026Separation Failure
The healthcare professional reported that during an endovascular embolization procedure, the 8mm x 30cm Complex Frame ((b)(4)) was impeded in the introducer sheath and could not be inserted into the associated microcatheter. The physician found that the proximal end of the introducer broke into two pieces; the physician then switched to a second coil to pack the aneurysm and successfully detached. A third coil, 8mm x 15cm Orbit Galaxy Complex Fill ((b)(4)) was used to pack the aneurysm, and it was found that the third coil was unable to be detached. The physician retracted the coil and replaced it with a fourth coil to complete the procedure using the original microcatheter. The procedure was prolonged by about 10 minutes. There was no report of any negative patient impact.On 24-Jul-2026, additional information was received. Per the information, the procedure was targeting the internal carotid artery. The third coil was still attached to the delivery system when it was removed. The syringe was filled with saline from a dedicated source. Before attempting to deploy the third coil, the syringe had previously exceeded the Green Zone/position 3. With the attempt to deploy the third coi
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100851 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.