ORBIT GALAXY ENPOWER XTRASOFT 641CX0408Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT Coil with Tight Distal Loop Technology 4mm x 8cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex XTRASOFT Coil with Tight Distal Loop Technology · 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 10878528009372), received between Jun 28, 2017 and Jun 28, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
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.
MalfunctionJun 28, 2017Positioning Failure; Positioning Failure
AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A BRAIN ANEURYSM EMBOLIZATION SURGERY, THE CODMAN DETACHMENT DEVICE (DCB0000500/C38341) AND THE CONNECTING CABLE (CCB00015700/P11121) WERE USED. TWO GALAXY G2 COILS (641CF0515/ S12682 AND 641CX0410/C32710), WERE SUCCESSFULLY DETACHED. HOWEVER, GALAXY COIL (641CX0408/S10322) WHICH WAS PLACED INTO THE ANEURYSM FAILED TO BE DETACHED DURING FIRST ATTEMPT. AFTER REPEATED DETACHMENT FAILURE ATTEMPTS WITH THE ABOVE-MENTIONED COIL, THE DETACHMENT DEVICE AND OF THE CONNECTING CABLE WERE REPLACED WITH NEW ITEMS (NEW ITEMS: DCB0000500/C38341 AND CCB00015700/P11121). HOWEVER, IN THE END THE COIL COULDN¿T BE DETACHED SUCCESSFULLY AND IT WAS WITHDRAWN FROM THE ANEURYSM. THE PROCEDURE WAS COMPLETED WITH A SAME LIKE PRODUCT. THERE WERE NO PATIENT INJURIES REPORTED. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6674297 ↗
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- 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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