ORBIT GALAXY 640CF0925Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704030409), received between May 31, 2017 and Jul 16, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, A 9X25 ORBIT GALAXY COIL 9X25 (640CF0925, 31342740) WAS IMPEDED IN DISTAL END OF MICROCATHETER (OTHER BRAND) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE COIL AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW COIL AND A NEW MICROCATHETER TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521337 ↗
• MalfunctionNov 28, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY COIL (640CF0925, 30848870) COULDN'T BE ADVANCED NOR BE RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18216490 ↗
• MalfunctionFeb 23, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 9MM X 25CM ORBIT GALAXY COMPLEX FILL COIL (640CF0925 / 30371449) WAS THE FIRST COIL USED. THE PHYSICIAN DECIDED TO RETRACT THE COIL FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN DECIDED TO REMOVE THE COIL BECAUSE ITS SIZE WAS NOT APPROPRIATE FOR THE TARGET ANEURYSM. THE COMPLAINT COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 23 FEBRUARY 2022, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588727 ↗
• MalfunctionApr 12, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE ILIAC ARTERY, THE 9MM X 25CM ORBIT GALAXY COMPLEX FILL COIL (640CF0925 / 30006826) WAS ONE OF THE COILS CHOSEN FOR THE PROCEDURE. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE CONCOMITANT MICROCATHETER DURING THE COIL DELIVERY. THE COIL INTRODUCER WAS VERIFIED TO BE FULLY SEATED AND SECURED IN THE HUB. THE COIL WAS REPLACED TO CONTINUE AND COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THERE WERE NO KINKS NOR BENDS IN THE COIL OR IN THE OTHER CONCOMITANT PRODUCTS PRIOR TO USE. AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF PATIENT COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THE 9MM X 25CM ORBIT GALAXY COMPLEX FILL COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 4/2/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510760 ↗
• MalfunctionMar 11, 2019Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE BRONCHIAL-ARTERY EMBOLIZATION OF AN ANEURYSM AT THE BRONCHIAL ARTERY, THE MICROCATHETER (CARRY LEON, UTM) WAS DELIVERED TO THE DISTAL END OF THE LESION AND THE 9MM X 25CM ORBIT GALAXY COMPLEX FILL COIL (640CF0925 / 17710990) WAS INSERTED BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER AS THE COIL GOT CLOSER TO THE DISTAL PART OF THE OF THE MICROCATHETER. THE PHYSICIAN INSERTED AND WITHDREW THE COIL SEVERAL TIMES, BUT THE RESISTANCE BECAME STRONGER. DUE TO THE INCREASED RESISTANCE, THE PHYSICIAN DECIDED TO REMOVE THE COIL AND PULLED ON THE COIL. THE COIL DELIVERY WIRE BECAME SEPARATED AT THE DISTAL BLUE PART AND BECAME FRAGMENTED INSIDE THE MICROCATHETER. THE MICROCATHETER WAS REMOVED FROM THE PATIENT AND IT WAS FLUSHED TO PUSH THE COIL AND THE SEPARATED DELIVERY WIRE OUT. ANOTHER MICROCATHETER AND COIL WERE USED AND THERE WAS ALSO RESISTANCE EXPERIENCED. THE COIL (UNKNOWN BRAND) DETACHED IN THE MIDDLE OF THE MICROCATHETER AND THE DETACHED COIL WAS IMPLANTED IN THE TARGET LESION BY FLUSHING WITH A SYRINGE. ADDITIONAL COILS WERE IMPLANTED USING THE SAME METHOD OF FLUSHING WITH THE SYRINGE. THE PROCEDURE WAS COMPLETE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409876 ↗
• MalfunctionOct 22, 2018Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM, THE ORBIT GALAXY COMPLEX FILL 9MM X 25CM COIL (640CF0925 / 17659794) WAS CHOSEN AS THE FIRST COIL. THE COIL WAS DELIVERED INTO THE MICROCATHETER (RESTAR, MEDICOS HIRATA) AND IT WAS MET WITH RESISTANCE. THE PHYSICIAN ATTEMPTED TO REMOVE THE ORBIT GALAXY COIL AND THE COIL BECAME UNRAVELED. BOTH THE COIL AND THE MICROCATHETER WERE REMOVED AS A UNIT AND THE UNRAVELED COIL WAS REMOVED FROM THE MICROCATHETER. THE SAME MICROCATHETER WAS THEN REINSERTED INTO THE LESION AND A COMPETITIVE COIL WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PLACEMENT OF FIVE COILS. THERE WERE NO FURTHER ISSUES OR DELAY REPORTED. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE ORBIT GALAXY COMPLEX FILL 9MM X 25CM COIL WAS REPORTED AS NOT AVAIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7993478 ↗
• MalfunctionMay 31, 2017Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, WHEN THE SURGEON ADVANCED AN ORBIT GALAXY COIL (640CF0925/ 17366792) INTO THE UNSPECIFIED MICROCATHETER, THE COIL DETACHED FROM THE DETACH ZONE. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER, AND THE MICROCATHETER DID NOT APPEAR DAMAGED. THE SURGEON USED ANOTHER COIL TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO POTENTIAL ADVERSE EVENTS. NO ADDITIONAL INFORMATION COULD BE OBTAINED. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6600574 ↗