ORBIT GALAXY ENPOWER XTRASOFT 641CX2535Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT Coi 2.5mm x 3.5cm 190cm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10878528008917), received between Sep 22, 2016 and Jun 18, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Positioning Failure1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION, A G2 COMPLEX XTRASOFT COIL (641CX2535, UNKNOWN LOT) BROKE FROM THE FIBER LOOP AND AUTO DETACH BEFORE DETACHMENT SYSTEM COMPLETE. THE DEVICE WAS REMOVED FROM THE MICROCATHETER. THE SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8708416 ↗MalfunctionSep 22, 2016Positioning Failure; Positioning Failure
AS REPORTED BY HEALTH CARE PROFESSIONAL, DURING A PROCEDURE COILS FAILED TO UNSHEATHE PROPERLY AND ONE DID NOT DETACH. ORBIT GALAXY, CATALOG# 641CX2535, LOT# C11960, ORBIT GALAXY, CATALOG# 641CF0306, LOT# P10635 AND ORBIT GALAXY, CATALOG# 64HX0204, LOT# P11693 ARE THE COILS REPORTED; HOWEVER IT IS UNKNOWN WHICH COIL FAILED TO DETACH AND WHICH COILS FAILED TO RE-SHEATH. THERE WERE NO ADVERSE EVENTS REPORTED. PATIENT INFORMATION AND PROCEDURE DETAILS ARE UNKNOWN. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICES ARE AVAILABLE FOR RETURN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5971190 ↗
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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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