ORBIT GALAXY 640CF0505Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704030287), received between Jun 25, 2026 and Jun 25, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A COMPETITIVE MICROCATHETER (MC) WAS IN PLACE AN ORBIT GALAXY COIL (PRODUCT CODE: 640CF0505, LOT NUMBER: 31204208) WAS DELIVERED TO TARGET SITE. THE COIL WAS PACKED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A SECOND COIL, ANOTHER ORBIT GALAXY (PRODUCT CODE: 640CF0510, LOT NUMBER: 31211764) AND TRIED TO DETACH IT, BUT THE SECOND COIL WAS ALSO UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE SECOND COIL ALONE AND SWITCHED TO A THIRD COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-JUN-2026 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DCB AND CONTROL CABLES WERE NOT USED WITH THE SUBSEQUENT COILS. THE COILS WERE ATTACHED TO THE COIL DELIVERY SYSTEMS WHEN REMOVED FROM THE PATIENT. THE COILS WERE NOT STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623147 ↗