ORBIT GALAXY XTRASOFT 640CX0404Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 4cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Xtrasoft Note: ONLY use with TRUFILL DCS Syringe II · Class 2
All models of ORBIT GALAXY XTRASOFT (18)
Data updated Oct 16, 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 10886704030614), received between Sep 9, 2026 and Sep 9, 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. 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
- 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.
MalfunctionSep 9, 2026Separation Failure
A healthcare professional reported that during an aneurysm embolization, an unspecified microcatheter was in place and an ORBIT GALAXY XTRASOFT (product code: 640CX0404, lot number: 31471128) coil was delivered to target site. The coil was packed in the aneurysm and tried to detach, but the coil was unable to detach. The doctor only retracted the coil alone and switched to a new one to complete the surgery. The microcatheter was not replaced. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694662 ↗
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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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