ORBIT GALAXY XTRASOFT 640CX0201Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704030539), received between May 13, 2022 and Sep 15, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING AN INTRA CRANIAL COIL EMBOLIZATION, A 2X1.5 ORBIT GALAXY XTRASOFT COIL DID NOT RESHEATH. THE SURGERY WAS DELAYED BY 5 MINUTES DUE TO THE EVENT. THE DEVICE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION AND ANOTHER COIL WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754687 ↗
• MalfunctionSep 13, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING AN INTRA CRANIAL COIL EMBOLIZATION, A 2X1.5 ORBIT GALAXY XTRASOFT COIL DID NOT RESHEATH. THE SURGERY WAS DELAYED BY 5 MINUTES DUE TO THE EVENT. THE DEVICE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION AND ANOTHER COIL WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739135 ↗
• MalfunctionMay 13, 2022Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, WHILE ADVANCING THE 2.5MM X 2.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2525 / 30566748) THROUGH THE MICROCATHETER, THERE WAS RESISTANCE AND THE COIL BECAME STUCK / IMPEDED IN THE MICROCATHETER. THE COIL WAS REMOVED AND ANOTHER COIL, A 2MM X 1.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0201 / 30628887) WAS USED BUT THE COIL GOT STRETCHED. THE REPORTED EVENT DELAYED THE PROCEDURE FOR HALF AN HOUR, IT WAS NOT REPORTED WHETHER THIS DELAY WAS CLINICALLY SIGNIFICANT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED; THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14400004 ↗