ORBIT GALAXY 640CF0615Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704030331), received between Oct 24, 2016 and Mar 23, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A MICROCATHETER (COMPETITOR¿S BRAND) WAS IN PLACE AND AN ORBIT GALAXY COIL (PRODUCT CODE: 640CF0615, LOT NUMBER: 31638655) WAS DELIVERED TO THE TARGET SITE. THE COIL WAS DEPLOYED WITHIN THE ANEURYSM. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL; HOWEVER, THE COIL DID NOT DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE. THE MICROCATHETER (MC) WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-MAR-2026 INDICATED THAT A TRUFILL DCS SYRINGE WAS USED. THE SAME SYRINGE WAS USED TO DETACH SUBSEQUENT COILS. THE SAME SYRINGE DID NOT PREVIOUSLY EXCEEDED THE GREEN ZONE/POSITION 3. AFTER THE COIL DID NOT DETACH AT THE SYRINGE GREEN ZONE, IT WAS ATTEMPTED TO DEPLOY THE COIL AT THE SYRINGE RED ALTERNATIVE DETACHMENT ZONE. PRIOR TO ATTEMPTING TO DETACH, IT WAS VERIFIED UNDER FLUORO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR DELIVERY TUBE. THE SYRINGE PRESSURIZED AS INTENDED. THERE WAS NO NECK REMODELING UTILIZED. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664590 ↗
• MalfunctionFeb 13, 2023Positioning Failure; Device Difficult to Setup or Prepare; Positioning Problem; Positioning Failure; Device Difficult to Setup or Prepare; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 6MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0615 / 30633038) COULD NOT BE RESHEATHED. THE COIL WAS REMOVED AND REPLACED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. ON 25-JAN-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REPORTED EVENT DID NOT RESULT IN ANY NEGATIVE PATIENT IMPACT. THE PROCEDURE WAS TARGETING AN ANEURYSM AT THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. THE PROCEDURAL SITUATION THAT LED TO THE RESHEATHING OF THE COIL WAS DUE TO POOR CONFORMABILITY AND COIL HERNIATION. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER; THERE WAS NO RESISTANCE EXPERIENCED. THE INTRODUCER SHEATH GOT PINCHED DURING THE RESHEATHING. THE INFORMATION INDICATED THAT THE MICROCATHETER WAS NOT REMOVED WITH THE COMPLAINT COIL. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 25-JAN-2023, THE EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369119 ↗
• InjuryJan 9, 2023Positioning Failure; Premature Separation; Positioning Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WHO WAS SUFFERING FROM AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION. AFTER THE ACCESS WAS ESTABLISHED, THE STENT MICROCATHETER REACHED THE A2 SEGMENT AND EMBOLIZATION WAS INITIATED AFTER THE MICROCATHETER FOR THE COIL (UNSPECIFIED BRAND) WAS IN PLACE. THE FIRST FOUR (4) COILS WERE AVENIR® COIL SYSTEM (WALLABY MEDICAL) FOLLOWED BY TWO (2) GALAXY 8MM X 7CM (PENDING DEVICE CLARIFICATION). THEN A 6MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0615 / 30558301) WAS USED. IT WAS FOUND THAT THE MICROCATHETER KICKED BACK WHILE THE COIL WAS BEING POSITIONED IN THE TARGET ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN WAS DISSATISFIED WITH THE AREA OF ANEURYSM EMBOLIZATION AND TRIED TO RETRACT THE STENT. WHEN HALF OF THE 6MM X 15CM ORBIT GALAXY COMPLEX FILL COIL WAS WITHDRAWN, IT WAS FOUND THAT THE COIL HAD BECOME PREMATURELY DETACHED IN THE PATIENT¿S BODY WITHOUT THE DETACHMENT INITIATION. THE MICROCATHETER THAT WAS USED FOR THE COIL WAS RETRACTED AND THE 6MM X 15CM ORBIT GALAXY COMPLEX FILL COIL WAS REMOVED BY RELEASING THE SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC). THE 6MM X 15CM ORBIT GALAXY

  Patient problems: Thrombosis/Thrombus; Vasoconstriction

  MAUDE report 16127385 ↗
• InjuryJun 6, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 55-YEAR-OLD MALE PATIENT (B)(6) WITH A HISTORY OF CONTROLLED HYPERLIPIDAEMIA, HYPERTENSION, CURRENT SMOKER SUBARACHNOID HEMORRHAGE (SAH) (TARGET ANEURYSM) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOA) ANEURYSM WITH HUNT & HESS GRADE 1, MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 6.4MM, DOME 6.5MM, MAXIMUM ANEURYSM DIAMETER 8.6MM, NECK SIZE 3.3MM, AND DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.4MM. COIL EMBOLIZATION WAS PERFORMED WITH SIX (6) CERENOVUS COILS: A 4MM X 10CM ORBIT GALAXY COMPLEX FILL (640CF0410 / 30396173), A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0304 / 30393990), A 7MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0715 / 304722037), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30396174), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30451949), AND A 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0202 / 30432544) VIA A PROWLER SELECT PLUS MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTE

  Patient problems: Aneurysm

  MAUDE report 14603875 ↗
• InjuryJun 6, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A (B)(6) MALE PATIENT (SUBJECT (B)(6)) WITH A HISTORY OF CONTROLLED HYPERLIPIDAEMIA, HYPERTENSION, CURRENT SMOKER SUBARACHNOID HEMORRHAGE (SAH) (TARGET ANEURYSM) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOA) ANEURYSM WITH HUNT & HESS GRADE 1, MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 6.4MM, DOME 6.5MM, MAXIMUM ANEURYSM DIAMETER 8.6MM, NECK SIZE 3.3MM, AND DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.4MM. COIL EMBOLIZATION WAS PERFORMED WITH SIX (6) CERENOVUS COILS: A 4MM X 10CM ORBIT GALAXY COMPLEX FILL (640CF0410 / 30396173), A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0304 / 30393990), A 7MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0715 / 304722037), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30396174), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30451949), AND A 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0202 / 30432544) VIA A PROWLER SELECT PLUS MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMP

  Patient problems: Aneurysm

  MAUDE report 14603829 ↗
• MalfunctionOct 1, 2021Positioning Failure; Material Separation; Positioning Failure; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WHO SUFFERED FROM ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH THE FOLLOWING DIMENSIONS: 5.7MM LENGTH, 5.5MM WIDTH, 3.2MM HEIGHT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE. THE OPERATOR FIRST CONSIDERED EMBOLIZING THE ANEURYSM WITH COIL. WHEN THE PHYSICIAN USED THE FIRST COIL, A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30558301), IT WAS REPORTED THAT THE COIL WAS ¿PARTIALLY DROPPED IN THE PARENT ARTERY¿ PROMPTING THE PHYSICIAN TO WITHDRAW THE COIL. DURING THE PROCESS OF WITHDRAWAL, THE COIL INTRODUCER FELL OFF. THE COIL WAS REPLACED. THE PHYSICIAN THEN DECIDED TO USE STENT-ASSISTED COIL EMBOLIZATION AND THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 6259376) WAS USED, BUT IT BECAME IMPEDED AND COULD NOT BE ADVANCED. THEN IT WAS FOUND THAT THE STENT PREMATURELY DEPLOYED IN THE Y-CONNECTOR. THE STENT WAS REMOVED AND A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR PATIENT COMPLICATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12564354 ↗
• MalfunctionJul 28, 2020Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, RE-SHEATING FAILED WITH A 1.5MM X 3CM DELTAXSFT10 (DLX100153, L15277 ) AND A 6X15 OG TDL CMPLX FILL COIL (640CF0615, 17710987). THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE FINDINGS OF THE DEVICE INVESTIGATION, THE EMBOLIC COIL WAS NOTED TO BEING STRETCHED AND KINKED ON THE DELTAXSFT10. THE EMBOLIC COIL WAS FOUND STRETCHED ON THE OG TDL CMPLX FILL COIL .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10333057 ↗
• MalfunctionOct 26, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT GRAFT (SG) COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT ILIAC ARTERY, THE ORBIT GALAXY COMPLEX FILL 6MM X 15CM COIL (640CF0615 / 17638001) WAS ONE OF THE COILS USED DURING THE PARENT ARTERY OCCLUSION PORTION OF THE PROCEDURE, BUT THE 6 MM X 15 CM ORBIT GALAXY COIL COULD NOT BE RESHEATHED. THE ZIPPER ON THE COIL COULD NOT BE UNZIPPED. IT WAS CONFIRMED THAT THE PHYSICIAN DID NOT APPLY EXCESSIVE FORCE DURING THE UNSHEATHING AND RESHEATHING OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. 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 6MM X 15CM COIL WAS RETURNED FOR EVALUATION AND THE EMBOLIC COIL WAS OBSERVED TO BE STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8010520 ↗
• MalfunctionFeb 8, 2018Premature Activation; Unraveled Material; Material Protrusion/Extrusion; Premature Activation; Unraveled Material; Material Protrusion/Extrusion

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM ON THE VERTEBRAL ARTERY DISSECTION IN A PATIENT WHOSE VESSEL IS NOT TORTUOUS NOR CALCIFIED, THE ORBIT GALAXY COMPLEX FILL COIL 6X15 (640CF0615 / 17650559) BECAME UNRAVELED WHEN IT WAS PUSHED IN AND OUT OF THE MICROCATHETER TWO TIMES DURING THE CREATION OF THE FRAME. THE DELIVERY WIRE WAS PUSHED IN AND PULLED OUT BUT THE COIL DID NOT MOVE; THE COIL BECAME DETACHED IN THE MICROCATHETER AND IT WAS PUSHED BY THE GUIDEWIRE (CHIKAI 0.014 IN 200CM, ASAHI INTECC). AS A RESULT, THE COIL DEVIATED FROM THE ANEURYSM INTO THE PARENT VESSEL. THE COIL WAS REPLACED BY THE FOLLOWING COILS: SMART COIL SOFT (HIRATA 5MM, 15CM) / HYDROSOFT, (TERUMO 4MM, 8CM)/ SMART COIL, SOFT (HIRATA 3.5MM, 8CM) / TARGET 360 NANO, AND STRYKER 2MM, 4CM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7256945 ↗
• MalfunctionFeb 9, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A SUBARACHNOID HEMORRHAGE OF THE INTERNAL CAROTID-POSTERIOR CEREBRAL ARTERY ANEURYSM, THERE WAS RESISTANCE BETWEEN AN ORBIT GALAXY (640CF0615/ 17449388) AND AN SL 10 MICROCATHETER, AND THE COIL BECAME KINKED. THE ORBIT GALAXY WAS THE FIRST COIL USED FOR THE PROCEDURE. THE COIL WAS REPLACED WITH ANOTHER SAME SIZE GALAXY COIL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO OR AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6314010 ↗
• MalfunctionNov 3, 2016Positioning Failure; Difficult to Advance; Positioning Failure; Difficult to Advance

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT INTERNAL CAROTID ARTERY AN ORBIT GALAXY COMPLEX FILL COIL (640CF0615/17397564) FAILED TO DETACH. IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN THE COMPLAINT COIL WAS INSERTED INTO THE LESION; THE PHYSICIAN TRIED TO DETACH THE COIL BUT THE COIL FAILED TO DETACH. THE COIL AND THE MICROCATHETER (COMPETITOR'S DEVICE) WERE REMOVED AS A UNIT AND THE COIL WAS REPLACED WITH ANOTHER COIL OF SAME SIZE (LOT UNKNOWN). THE DCS SYRINGE II (LOT UNKNOWN) WAS USED TO SUCCESSFULLY DEPLOY ANY COILS PRIOR TO OR AFTER THE COMPLAINT COIL. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. PATIENT (B)(6) WAS A (B)(6) -YEAR-OLD FEMALE WHOSE VESSELS WERE MILDLY TORTUROUS AND MILDLY CALCIFIED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES. NO VISIBLE DEFECT OR DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RETUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6077157 ↗
• MalfunctionOct 24, 2016Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, THE PHYSICIAN PULLED THE GALAXY COMPLEX FILL COIL (640CF0615/17112402) AND THE UNIDENTIFIED MICROCATHETER AT THE SAME TIME. AFTER INSPECTION THE COIL WAS FOUND TO BE STRETCHED. THE PATIENT INFORMATION AND PROCEDURE DETAILS ARE UNKNOWN. IT WAS INITIALLY REPORTED THAT THE PRODUCT IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6050271 ↗