ORBIT GALAXY XTRASOFT 640HX0204Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886704030713), received between May 25, 2017 and Jan 14, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Stretched” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Stretched

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A 2X4 ORBIT GALAXY XTRASOFT COIL (640HX0204, 31722202) WAS UNRAVELED OR STRETCHED. THE COIL'S SHAPE WAS FOUND TO BE NOT IDEAL WHILE FILLING THE TARGET SITE, LEADING THE PHYSICIAN TO RETRACT THE COIL, AT WHICH POINT THE DEVICE WAS OBSERVED TO BE UNRAVELED/STRETCHED. THE PHYSICIAN COMPLETED THE PROCEDURE USING A COIL FROM ANOTHER BRAND, AND THE MICROCATHETER WAS NOT REPLACED. THERE WERE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067813 ↗
• MalfunctionSep 16, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT AFTER THE SL-10® MICROCATHETER (STRYKER) MICROCATHETER WAS POSITIONED FOR COILING, THE ORBIT GALAXY XSFT 2X4 (640HX0204 / 30927737) WAS FULLY PLACED IN THE MICROCATHETER HUB AND ADVANCED THE SAME. AFTER COMPLETE COIL & PART OF BLUE CORE WIRE WENT INSIDE THE MICROCATHETER (MC), THE DOCTOR FELT THE RESISTANCE AND COULDN'T ADVANCE FURTHER. HENCE THE DOCTOR RE-SHEATH THE COIL AND TRACKED THE WIRE TILL THE ANEURYSM. THERE WAS NO RESISTANCE IN THE MICRO CATHETER. ONCE AGAIN, HE TRIED WITH THE SAME ORBIT GALAXY 2X4, AND HE ENCOUNTERED THE SAME PROBLEM. THEREFORE, THE DOCTOR REMOVED IT AND KEPT IT AS DAMAGED. ADDITIONAL EVENT INFORMATION STATES THAT NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. CONTINUOUS WAS FLUSH MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226225 ↗
• MalfunctionMar 19, 2024Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0304 / 30916585) AND THE 2MM X 4CM ORBIT GALAXY HELICAL XTRASOFT COIL (640HX0204 / 30927737) WERE UNABLE TO BE RESHEATHED. THE PROCEDURE WAS DELAYED BY 10 MINUTES. THE COILS WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 02-FEB-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL OF THE PROCEDURE WAS AN ACOM ANEURYSM. IT WAS DUE TO POSITIONING DIFFICULTY THAT LED TO THE REPORTED RESHEATHING ISSUE. THERE WAS NO DAMAGE NOTED ON THE INTRODUCER SHEATH OF THE COILS. THERE WAS NO RESISTANCE DURING THE ADVANCEMENT OF THE COILS THROUGH THE MICROCATHETER. NECK REMODELING DEVICE WAS NOT USED DURING THIS PROCEDURE. THE COILS WERE NOT POSITIONED AT A RELATIVELY SHARP ANGLE IN RELATION TO THE MICROCATHETER. THE INFORMATION ALSO INDICATED THAT THE 10 MINUTE DELAY WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSES. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 19-MAR-2024, THE REPORTED ISSUE WITH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937500 ↗
• MalfunctionNov 26, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE DEVICE PACKAGING WAS OPENED AND THE DEVICE, A 2MM X 4CM ORBIT GALAXY HELICAL XTRASOFT COIL (640HX0204 / 31032531) WAS PARTIALLY PUSHED OUT OF THE INTRODUCER SHEATH TO INSPECT THE DEVICE. THE PHYSICIAN ENCOUNTERED RESISTANCE AND OBSERVED THAT THE EMBOLIC COIL COMPONENT WAS UNRAVELED / STRETCHED. THE DEVICE WAS NOT USED IN THE PATIENT; A NEW DEVICE WAS USED AS REPLACEMENT FOR THE PROCEDURE. THERE WAS NO NEGATIVE PATIENT IMPACT. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE REPLACEMENT COIL WAS ANOTHER 2MM X 4CM ORBIT GALAXY HELICAL XTRASOFT (640HX0204). NO ADDITIONAL DAMAGE OTHER THAN THE UNRAVELED / STRETCHED CONDITION REPORTED WAS NOTED ON THE COMPLAINT COIL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207777 ↗
• MalfunctionSep 6, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY AN ORBIT GALAXY HELICAL XTRASOFT COIL (640HX0204 / 30723400) THROUGH A 150CM X 5CM, 45-DEGREE PROWLER SELECT PLUS MICROCATHETER (606S155FX / 30763314), BUT WHILE ADVANCING THE COIL MIDWAY THROUGH, THE PHYSICIAN ENCOUNTERED RESISTANCE INSIDE THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO PUSH THE COIL FORWARD AND WAS UNABLE TO RETRACT THE COIL OUT FROM THE MICROCATHETER. AS A RESULT, THE PHYSICIAN REMOVED THE MICROCATHETER AND THE COIL TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND NEW COIL. ON 24-AUG-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL WAS THE ANTERIOR COMMUNICATING ARTERY (ACOM). THE COMPLAINT DEVICES DID NOT APPEAR DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. BASED ON THE ADDITIONAL EVENT INFORMATION ON 24-AUG-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366780 ↗
• MalfunctionJul 18, 2022Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, THE COIL PUSHER WIRE OF THE 2MM X 4CM ORBIT GALAXY HELICAL XTRASOFT (640HX0204 / 30723398) WAS BROKEN INSIDE THE MICROCATHETER RESULTING IN A 10-MINUTE DELAY IN THE PROCEDURE. THE COIL WAS REMOVED FROM THE MICROCATHETER. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. ON 28-JUN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THAT THERE WAS NO ADVERSE PATIENT CONSEQUENCE. THE DELIVERY WIRE WAS SEPARATED INTO TWO (2) PIECES. THE CAUSE OF THE REPORTED ISSUE IS NOT KNOWN. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE COMPLAINT DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT AS THE DELIVERY WIRE WAS BROKEN INTO TWO PIECES AND THERE WAS A PART OF THE WIRE IN THE MICROCATHETER; SO THE COIL WAS FULLY REMOVED FROM THE PATIENT WITHOUT REMOVING THE MICROCATHETER. BASED ON THE ADDITIONAL INFORMATION, THE EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15046380 ↗
• MalfunctionMay 23, 2022Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2X4 ORBIT GALAXY COIL (640HX0204, 30571045) BECAME UNRAVELED/STRETCHED IN THE UNSPECIFIED MICROCATHETER (MC). THE PHYSICIAN SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469082 ↗
• MalfunctionFeb 11, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A (B)(6) MALE PATIENT WAS SUFFERING FROM A RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM UNDERWENT ENDOVASCULAR EMBOLIZATION. DURING THE PROCEDURE, THE COMPLAINT COIL, A 2MM X 4CM ORBIT GALAXY HELICAL XTRASOFT (640HX0204 / 30570500) WAS ADVANCED IN A CONCOMITANT MICROCATHETER (COMPETITOR BRAND), THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WHEN IT REACHED THE TARGET POSITION, BUT THE COIL COULD NOT BE DETACHED AFTER THREE ATTEMPTS. A COMPETITOR BRAND COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518681 ↗
• MalfunctionAug 4, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2X4 ORBIT GALAXY XTRASOFT COIL (640HX0204) FAILED TO DETACH. IT WAS REPORTED THAT THE COIL COULDN'T BE DETACHED WHEN IT ARRIVED AT THE TARGET POSITION. THE PHYSICIAN WITHDREW THE COIL OUTSIDE OF THE PATIENTS BODY AND SWITCHED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO INJURY REPORTED. A PICTURE WAS RECEIVED AT THE TIME OF COMPLAINT ENTRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276057 ↗
• InjuryJul 14, 2021Positioning Failure; Separation Failure; Difficult to Advance; Premature Separation; Positioning Failure; Separation Failure; Difficult to Advance; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT COIL EMBOLIZATION OF A RUPTURED MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH). DURING THE PROCEDURE, A 2MM X 4CM ORBIT GALAXY HELICAL XTRSOFT (640HX0204/30412431) COIL BECAME ¿IMPEDED TO REACH THE TARGET POSITION WHEN USED SYRINGE TO MAKE COIL DETACH¿. THE PHYSICIAN ATTEMPTED TO RETRACT THE CONCOMITANT MICROCATHETER (SIZE/BRAND NOT SPECIFIED) TO ADJUST ITS POSITION, BUT THE COIL HAD UNINTENDEDLY DETACHED. AS THE MICROCATHETER WAS BEING WITHDRAWN, THE PREMATURELY DETACHED COIL ¿FELL¿ INTO THE INTERNAL CAROTID ARTERY (ICA) REQUIRING USE OF A SOLITAIRE AB (MEDTRONIC) STENT RETRIEVER TO REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS DELAYED ABOUT 40 MINUTES DUE TO THE EVENT. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR MONITORING. SELECT PROCEDURAL IMAGING WAS FORWARDED TO AN INDEPENDENT NEUROENDOVASCULAR SURGEON FOR REVIEW. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167353 ↗
• MalfunctionMar 17, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING AN ANTERIOR COMMUNICATING ANEURYSM EMBOLIZATION, THE COIL BODY OF A 2X4 OG HELICAL XTRSOFT COIL (640HX0204, 30409481) COULDN¿T BE RECAPTURED INTO THE INTRODUCER. THE PHYSICIAN FOUND THE COIL DIDN¿T DEMONSTRATE WELL SO HE PLANNED TO RECAPTURE IT. THE PHYSICIAN SWITCHED TO A DELTAPLUSH1.5X2MM TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11505790 ↗
• MalfunctionJun 11, 2019Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM, THE 2MM X 4CM ORBIT GALAXY HELICAL XRASOFT COIL (640HX0204 / LOT# UNK) REACHED THE TARGET LESION BUT IT COULD NOT BE DETACHED USING THE SYRINGE. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689522 ↗
• MalfunctionNov 6, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, WHEN THE ORBIT GALAXY HELICAL XTRASOFT 2MM X 4CM COIL (640HX0204 / 17745226) WAS TAKEN OUT OF THE PACKAGE, A KINK WAS NOTED ON THE DELIVERY WIRE. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THERE WAS NO DAMAGE NOTED ON THE PACKAGING; THE INTEGRITY OF THE SEAL ON THE POUCH WAS NOT COMPROMISED. THE REPORTED ISSUE DID NOT CAUSE ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. THE PRODUCT IS AVAILABLE TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8043951 ↗
• MalfunctionOct 30, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE ORBIT GALAXY HELICAL XTRASOFT 2MM X 4CM COIL WAS THE 4TH COIL USED, AND IT BECAME STRETCHED. THE COIL WAS WITHDRAWN, AND THE PROCEDURE WAS REPORTED AS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8020381 ↗
• MalfunctionMar 20, 2018Difficult To Position; Retraction Problem; Difficult To Position; Retraction Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM, THE SURGEON WANTED TO ADJUST THE POSITION OF THE 2MM X 4CM ORBIT GALAXY HELICAL XTRASOFT (640HX0204/17673404) AND THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3575/17685003) AS THE COILS WOULD NOT CONFORM TO THE WALLS OF THE ANEURYSM, BUT THE COILS COULD NOT BE WITHDRAWN BACK INTO THE UNSPECIFIED MICROCATHETER. THE ISSUE REQUIRED THAT THE COILS AND MICROCATHETER BE REMOVED AS A UNIT. THE COILS WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THERE WAS NO LOSS OF CEREBRAL TARGET POSITION ASSOCIATED WITH THE EVENT. NO PATIENT COMPLICATION OCCURRED AS A RESULT OF THE EVENT. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COILS THROUGH THE MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO APPARENT KINKS IN THE MICROCATHETER. A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352812 ↗
• MalfunctionJul 6, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A OG HELICAL XTRSOFT COIL 2X4 (640HX0204/ 17507918) WAS FOUND TO BE STRETCHED BEFORE USE. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON THE PATIENT INJURY. THERE WERE NO DELAYS OR INTERVENTIONAL TREATMENT DUE TO THE EVENT. THERE WERE NO DAMAGES NOTED ON THE INNER PRODUCT POUCH, OUTER PRODUCT BOX OR THE SHIPPING BOX. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6690066 ↗
• MalfunctionMay 25, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE AN OG HELICAL XTRSOFT COIL 2X4 (640HX0204/17622804) FAILED TO DETACH. THE PROCEDURE WAS EMBOLIZATION OF A LEFT MIDDLE ARTERY ANEURYSM OF SIZE 3.2X3.5MM IN A (B)(6) FEMALE. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT EXCESSIVE FORCE. THE COMPLAINT COIL WAS WITHDRAWN AND NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE SAME CONNECTING CABLE AND DCB WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THERE WERE NO DAMAGES NOTED TO THE COIL/COIL DELIVERY SYSTEM/DETACHMENT SYSTEM PRIOR TO USE OR UPON REMOVAL. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE AT PATIENT AND NO STRETCHING WAS NOTED. THERE WAS NO REPORT ON PATIENT INJURY. THERE WERE NO DELAYS OR INTERVENTIONAL TREATMENTS DUE TO THE EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6590145 ↗