ORBIT GALAXY ENPOWER XTRASOFT 641CX3509Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT 3.5mm x 9cm 190cm Coil 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 10878528008986), received between Oct 29, 2018 and Oct 29, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Stretched” (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
- 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.
MalfunctionOct 29, 2018Stretched; Stretched
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WHILE THE G2 STRETCH RESISTANT COMPLEX XTRASOFT 3.5MM X 9CM COIL (641CX3509 / S13503) WAS BEING ADVANCED THROUGH THE MICROCATHETER, THE COIL WAS MET WITH GREAT RESISTANCE. WHEN THE COIL WAS REMOVED, IT WAS STRETCHED. ANOTHER COIL WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8015411 ↗
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- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
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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