ORBIT GALAXY ENPOWER 641CF0201Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil 2mm x 1.5cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex Fill Coil · Class 2 · Implant
All models of ORBIT GALAXY ENPOWER (16)
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 10878528009426), received between Jan 6, 2017 and Jan 6, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance” (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
- Physical Resistance1
- 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.
MalfunctionJan 6, 2017Stretched; Physical Resistance; Stretched; Physical Resistance
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ELECTIVE COILING PROCEDURE TO TREAT A SECULAR MODERATELY WIDE NECK ACOM ANEURYSM A G2 COMPLEX FILL COIL 2X1.5 (B)(4) GOT STRETCHED WHILE REPOSITIONING. THE COIL WAS REMOVED ALONG WITH THE ECHELON 10 MICROCATHETER AND SLIGHT RESISTANCE WAS FELT. NO RESISTANCE WAS ENCOUNTERED BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. NOR WAS THERE ANY RESISTANCE WHEN ADVANCING THE COIL THROUGH THE MICROCATHETER. OTHER COILS HAD SUCCESSFULLY BEEN PASSED THROUGH THE SAME MICROCATHETER WITHOUT ISSUE. THE G2 COMPLEX FILL COIL 2X1.5 (COMPLAINT PRODUCT) WAS THE LAST COIL ATTEMPTED TO FILL THE NECK. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS NOT VERIFIED WITH FLUORO PRIOR TO REPOSITIONING. ADDITIONAL INTERVENTION WAS NOT REQUIRED AS THE CASE WAS ABANDONED. THERE WERE NO PATIENT COMPLICATIONS OR PROCEDURAL DELAY AS A RESULT OF THIS EVENT. REPORTEDLY, THE ANEURYSM WAS 4MM IN HEIGHT, 3.5MM IN WIDTH, AND THE NECK WAS 2.5MM WITH NORMAL VESSEL CHARACTERISTICS. NECK REMODELING WAS NOT UTILIZED DURING THIS PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. T
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6230682 ↗
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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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