ORBIT GALAXY XTRASOFT 640CX2525Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704030669), received between Mar 5, 2018 and Jun 20, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2022Failure to Advance; Failure to Advance

  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. THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. DURING THE MICROSCOPIC INSPECTION, THE COIL WAS OBSERVED TO BE IN A KINKED CONDITION. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 20-JUN-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14749747 ↗
• MalfunctionApr 11, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE PHYSICIAN TRIED TO DEPLOY A 2.5X2.5 ORBIT GALAXY XTRASOFT (640CX2525, 30461376) THROUGH AN ECHELON 10 MICROCATHETER (MC). HOWEVER, WHILE ADVANCING IT MIDWAY THROUGH THE CATHETER THE DOCTOR FELT RESISTANCE. AFTER A FEW TRIES, THE DOCTOR REMOVED THE COIL AND DEPLOYED COMPETITIVE COILS TO COMPLETE THERE WAS NO SURGERY DELAYS DUE TO THE REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS OBSERVED TO BE STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073780 ↗
• InjuryJun 15, 2018Unraveled Material; Physical Resistance; Unraveled Material; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A VERTEBRAL ARTERY ANEURYSM, THE 2.5X2.5 ORBIT GALAXY CMPLX XTRASOFT ((640CX2525/17612969) HYDRAULIC COIL WAS SELECTED FOR USE AS THE 9TH COIL AND DELIVERED INTO THE SL-10 (STRYKER) MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE MIDDLE PORTION OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DELIVERY WIRE BUT THE COIL UNRAVELED. THE COIL WAS REMOVED WITH THE MICROCATHETER AND THE MICROCATHETER WAS REPLACED. THE REPLACEMENT MICROCATHETER WAS DIFFICULT TO DELIVER AND THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL COIL EMBOLIZATION. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE MICROCATHETER. A Y-CONNECTOR WAS ALSO USED FOR THE CASE. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7607711 ↗
• MalfunctionMar 5, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM ON THE LEFT INTERNAL CAROTID ARTERY ON A (B)(6) FEMALE PATIENT, AFTER AN ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE WAS PLACED AND THE COIL EMBOLIZATION WAS STARTED AT THE STENT JAILED BY AN ORBIT GALAXY 5X10 COIL, THREE COILS (ONE 4X6 COIL AND TWO 3X4 COILS) WERE DETACHED, THE PHYSICIAN ATTEMPTED TO DETACH THE ORBIT GALAXY XTRASOFT COIL (640CX2525 / 17650567), BUT THE COIL FAILED TO DETACH. THE COIL WAS REPLACED WITH ANOTHER ORBIT GALAXY XTRASOFT COIL WITH THE SAME SIZE AND LOT NUMBER (640CX2525 / 17650567), AND THE SAME FAILURE TO DETACH ISSUE WAS ENCOUNTERED. THE COIL WAS REPLACED AND TWO ADDITIONAL COILS (2X2) WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7314094 ↗
• MalfunctionMar 5, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM ON THE LEFT INTERNAL CAROTID ARTERY ON A (B)(6) FEMALE PATIENT, AFTER AN ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE WAS PLACED AND THE COIL EMBOLIZATION WAS STARTED AT THE STENT JAILED BY AN ORBIT GALAXY 5X10 COIL, THREE COILS (ONE 4X6 COIL AND TWO 3X4 COILS) WERE DETACHED, THE PHYSICIAN ATTEMPTED TO DETACH THE ORBIT GALAXY XTRASOFT COIL (640CX2525 / 17650567), BUT THE COIL FAILED TO DETACH. THE COIL WAS REPLACED WITH ANOTHER ORBIT GALAXY XTRASOFT COIL WITH THE SAME SIZE AND LOT NUMBER (640CX2525 / 17650567), AND THE SAME FAILURE TO DETACH ISSUE WAS ENCOUNTERED. THE COIL WAS REPLACED AND TWO ADDITIONAL COILS (2X2) WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7314085 ↗