ORBIT GALAXY ENPOWER XTRASOFT 641HX0206Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY G2 microcoil Stretch Resistant Helical XTRASOFT Coil 2mm x 6cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Helical 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 10878528009402), received between Aug 8, 2017 and Aug 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Kinked” (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
- Kinked1
- Stretched1
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.
MalfunctionAug 8, 2017Kinked; Stretched; Kinked; Stretched
AS REPORTED BY A HEALTHCARE PROFESSIONAL, A GALAXY G2 COIL ((B)(4)) COULD NOT BE PUSHED THROUGH THE DISTAL SHAFT OF THE STRYKER MICROCATHETER AND PRODUCT ANALYSIS REVEALED THAT THE COIL WAS KINKED AND STRETCHED. IT WAS REPORTED THAT A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND THE MICROCATHETER DID NOT APPEAR DAMAGED. THE COIL WAS REMOVED WITHOUT DIFFICULTY AND THE PROCEDURE WAS CONTINUED WITH ANOTHER COIL. THE G2 DID NOT APPEAR DAMAGED (I.E. KINKED, STRETCHED, SEPARATED, DETACHED), AND THE DEVICES WERE USED AND PREPPED AS PER THE IFU. THERE WAS NO PATIENT INJURY OR PROCEDURE DELAY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6773690 ↗
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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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