ORBIT GALAXY ENPOWER 641CF0615Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY G2 microcoil Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology 6mm x 15cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex Fill Coil with Tight Distal Loop Technology · 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 10878528009587), received between Jan 18, 2019 and Jan 18, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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 Twisted/Bent1
- Physical Resistance/Sticking1
- 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 18, 2019Stretched; Material Twisted/Bent; Physical Resistance/Sticking; Stretched; Material Twisted/Bent; Physical Resistance/Sticking
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) ANEURYSM, THE PHYSICIAN ATTEMPTED TO PUSH THE 6MM X 15CM G2 TDL COMPLEX FILL COIL (641CF0615 / S13661) THROUGH THE PROWLER SELECT LPES MICROCATHETER (30023533 / UNKNOWN LOT#) WHEN THE COIL WAS MET WITH RESISTANCE AND BECAME BENT DISTALLY. IT WAS CONFIRMED THAT THE GUIDEWIRE DID NOT EXPERIENCE ANY RESISTANCE, THERE WAS NO KINK OR DAMAGE ON THE MICROCATHETER, THE MICROCATHETER DID NOT HAVE ANY OBSTRUCTION, AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN REPLACED THE G2 COIL AND COMPLETED THE PROCEDURE WITH THE REPLACEMENT COIL. THERE WAS NO PROCEDURAL DELAY FROM THE REPORTED ISSUE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. THE PRODUCT WAS REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8262923 ↗
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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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