ORBIT GALAXY ENPOWER 641CF0824Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10878528009631), received between May 29, 2019 and May 29, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Stretched” (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.

• MalfunctionMay 29, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE LEFT INTERNAL CAROTID ARTERY (ICA), THE 8MM X 24CM ORBIT GALAXY G2 COIL (641CF0824 / S13607) WAS ONE OF TWO COILS THAT WERE USED IN; DURING COIL DELIVERY, THE COIL BECAME STRETCHED INSIDE THE SL-10® MICROCATHETER (STRYKER). THE REPORTED ISSUE OCCURRED DURING COIL WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WERE NO KINKS ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE; THERE WAS NO REPORT OF COIL ENTANGLEMENT THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE OF THE COIL BECOMING STRETCHED DURING THE COIL DELIVERY ATTEMPT. THE COIL WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO FLOW RESTRICTION OR REDUCTION AS A RESULT OF THE ISSUE REPORTED; THERE WAS ALSO NO REPORT OF PATIENT INJURY OR COMPLICATION, NO SIGNIFICANT PROCEDURAL DELAY AS A RESULT OF THE REPORTED ISSUE. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650385 ↗
• MalfunctionMay 29, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE LEFT INTERNAL CAROTID ARTERY (ICA), THE 8MM X 24CM ORBIT GALAXY G2 COIL (641CF0824 / S13665) WAS ONE OF TWO COILS THAT WERE USED IN; DURING COIL DELIVERY, THE COIL BECAME STRETCHED INSIDE THE SL-10® MICROCATHETER (STRYKER). THE REPORTED ISSUE OCCURRED DURING COIL WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WERE NO KINKS ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE; THERE WAS NO REPORT OF COIL ENTANGLEMENT THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE OF THE COIL BECOMING STRETCHED DURING THE COIL DELIVERY ATTEMPT. THE COIL WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO FLOW RESTRICTION OR REDUCTION AS A RESULT OF THE ISSUE REPORTED; THERE WAS ALSO NO REPORT OF PATIENT INJURY OR COMPLICATION, NO SIGNIFICANT PROCEDURAL DELAY AS A RESULT OF THE REPORTED ISSUE. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650383 ↗