ORBIT GALAXY ENPOWER XTRASOFT 641CX0308Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10878528008955), received between Sep 25, 2018 and Oct 30, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WHILE THE G2 STRETCH RESISTANT COMPLEX XTRASOFT COIL 3MM X 8CM COIL (641CX0308 / S12724) 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 8020098 ↗
• MalfunctionSep 25, 2018Stretched; Separation Failure; Material Twisted/Bent; Stretched; Separation Failure; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM, THE 3MM X 8CM G2 COMPLEX XTRASOFT (641CX0308/S12724) THERMO-MECHANICAL COIL FAILED TO DETACH DESPITE MULTIPLE ATTEMPTS. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT DID NOT ILLUMINATE, AND THE AUDIBLE SIGNAL DID NOT BEEP. THE PHYSICIAN REPLACED THE CODMAN CONNECTING CABLE (CCB00015700/S12886), BUT THE ISSUE CONTINUED. THEREFORE, THE COIL WAS REMOVED FROM THE PATIENT AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FOUR ADDITIONAL ORBIT GALAXY COILS. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PHYSICIAN INSERTED THE COIL INTO THE UNSPECIFIED MICROCATHETER AND COIL WAS ADVANCED AND DEPLOYED IN THE ANEURYSM WITHOUT INCIDENT. AFTER THE RADIOPAQUE MARKERS WERE CROSSED, THE PHYSICIAN CONNECTED THE CONTROL CABLE TO THE COIL HUB AND PRESSED THE DETACHMENT BUTTON, BUT THE COIL FAILED TO DETACH. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT NEED FOR ADDITIONAL INTERVENTION. THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE CASE. THE COIL DELIVERY SYSTEM WAS PREPPED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906104 ↗