ORBIT GALAXY 640CR0620Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704030430), received between May 23, 2018 and Dec 15, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2021Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE DURING THE ADVANCEMENT OF THE 6MM X 20CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0620 / 30383959) THROUGH THE CONCOMITANT ECHELON¿ 10 MICROCATHETER (MEDTRONIC); THE RESISTANCE WAS IN THE MID-SHAFT OF THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. IT WAS REPORTED THAT NOTHING WAS OBSTRUCTING THE MICROCATHETER, THE INTRODUCER WAS FLUSHED AND FIRMLY INSTALLED ONTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE DEVICE ADVANCEMENT. OTHER ORBIT GALAXY COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO THE REPORTED ISSUE. THE 6MM X 20CM ORBIT GALAXY COMPLEX FRAME COIL WAS SUCCESSFULLY REMOVED FROM THE CONCOMITANT MICROCATHETER WITHOUT THE MICROCATHETER REMOVED FROM THE TARGET POSITION. NO DAMAGE WAS NOTED ON THE COMPLAINT COIL. THE COIL WAS REPLACED. THE EVENT RESULTED IN A 10-MINUTE PROCEDURE DELAY BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014425 ↗
• MalfunctionDec 9, 2021Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A CAROTID CAVERNOUS FISTULA (CCF) EMBOLIZATION, WHEN USING AN ECHELON 10 MICROCATHETER (MC), THE PHYSICIAN DEPLOYED A 6X15 ORBIT GALAXY COIL AND A 6X20 ORBIT GALAXY COIL. THEN TRIED TO DEPLOY TWO 7X25 ORBIT GALAXY COILS (640CR0725, 30579160) AND A 6X20 ORBIT GALAXY COIL (640CR0620, UNKNOWN LOT). ALL THREE COILS FACED RESISTANCE IN THE MICROCATHETER MIDWAY. THE 6X20 ORBIT GALAXY COIL DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED ALL THESE COILS AND COMPLETED THE CASE. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968018 ↗
• MalfunctionMay 25, 2021Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL PROCEDURE, A OG TDL CMPLX FRAME COIL 6X20 (640CR0620, 30451950) DETACHED IN THE UNSPECIFIED MICROCATHETER (MC). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER COIL AND MICROCATHETER. NO ADDITIONAL INFORMATION WAS PROVIDE AT THE TIME OF COMPLAINT ENTRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877241 ↗
• MalfunctionMay 21, 2021Retraction Problem; Positioning Problem; Retraction Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM COIL PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY THE 6MM X 20CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0620 / 30383959) INSIDE THE ANEURYSM THEN TRIED TO RETRIEVE THE COIL SINCE IT WAS NOT ADEQUATELY FRAMING THE ANEURYSM, BUT THE PHYSICIAN WAS UNABLE TO RETRIEVE THE COIL FROM THE ANEURYSM FULLY. AS A RESULT, THE PHYSICIAN REMOVED THE WHOLE SYSTEM INSIDE THE GUIDE CATHETER AND COMPLETED THE CASE WITH ANOTHER 6MM X 20CM ORBIT GALAXY COIL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11865631 ↗
• MalfunctionSep 9, 2020Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRACRANIAL ANEURYSM COIL EMBOLIZATION PROCEDURE, THERE WAS SOME RESISTANCE FELT BETWEEN THE 6MM X 20CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0620 / 30219616) AND THE CONCOMITANT ECHELON¿ 10 MICROCATHETER (MEDTRONIC). AND THEN WHILE THE PHYSICIAN WAS PULLING THE COIL, IT BECAME DETACHED FROM THE DETACHMENT ZONE. THE PHYSICIAN REMOVED THE COIL AND REPLACED IT WITH ANOTHER COIL. THE REPORTED EVENT RESULTED IN A 15-MINUTE PROCEDURAL DELAY, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511464 ↗
• MalfunctionMay 23, 2018Kinked; Kinked

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE ORBIT GALAXY TDL COMPLEX FRAME COIL 6 X 20 (640CR0620 / 17656469) WAS ADVANCED INTO THE STRYKER SL 10 MICROCATHETER BUT THERE WAS FRICTION AND THE COIL BUNCHED UP IN THE MICROCATHETER. THE COIL WAS REMOVED FROM THE MICROCATHETER WITHOUT ANY DAMAGE. THERE WAS NO REPORT OF PATIENT INJURY; THERE WAS NO PROCEDURAL DELAY DUE TO THE REPORTED EVENT. IT WAS NOT KNOWN IF THERE WAS LOSS OF CEREBRAL TARGET POSITION. PER THE PHYSICIAN, THERE WAS A LOT OF THE SL 10 MICROCATHETER THAT WERE DEFECTIVE, BUT THE SL 10 MICROCATHETER USED WITH THE COIL FOR THIS PROCEDURE WAS NOT PART OF THAT LOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7539218 ↗