ORBIT GALAXY ENPOWER XTRASOFT 641CX3575Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT Coil 3.5mm x 7.5cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex XTRASOFT Coil · Class 2 · Implant
All models of ORBIT GALAXY ENPOWER XTRASOFT (15)
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 10878528008979), received between May 8, 2017 and May 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material 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.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2017Material Separation; Material Separation
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COILING OF AN ANEURYSM A RESISTANCE WAS EXPERIENCED WHEN USING A GALAXY G2 3.5X7.5 COIL. THE COIL WAS INTRODUCED INTO AN UNKNOWN COILING MICROCATHETER; HOWEVER, IT BECAME STUCK AND BROKE OFF IN THE CATHETER. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS DEVICE FAILURE. THE PROCEDURE WAS DELAYED BY 10 MINUTES. THE BROKEN DEVICE WAS EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6551717 ↗
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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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