ORBIT GALAXY XTRASOFT 640CX0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704030645), received between May 9, 2018 and May 28, 2026 — classified as 1 death, 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Stretched” (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.

• DeathMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE FIRST COIL, A 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0410 / 31770622) AND THE SECOND COIL, A 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3575 / 31770623) WERE PACKED WITHIN THE ANEURYSM. SUBSEQUENTLY, WHILE PACKING THE ANEURYSM WITH COILS FROM OTHER BRANDS, THE ANEURYSM RUPTURED AND BLEEDING WAS OBSERVED. THE PHYSICIAN IMPLANTED TWO STENTS (FROM OTHER MANUFACTURERS). A CRANIOTOMY WAS PERFORMED THEREAFTER. ON 27-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ANEURYSM RUPTURED AFTER THE FIRST AND SECOND COIL WERE IMPLANTED AND DURING THE PACKING OF THE ANEURYSM WITH NON-CERENOVUS COILS. THE INFORMATIONAL ALSO INDICATED THAT THE PATIENT IS DECEASED; THE EXACT DATE OF DEATH IS UNKNOWN. THE PHYSICIAN CONSIDERED THE ANEURYSM RUPTURE TO BE UNRELATED TO CERENOVUS COILS. THERE WAS NO DELAY TO THE ENDOVASCULAR EMBOLIZATION PROCEDURE.

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 25321570 ↗
• MalfunctionNov 21, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE FIRST COIL, A 2MM X 6CM ORBIT GALAXY HELICAL XTRASOFT (640HX0206 / 31467317) WAS DELIVERED TO THE TARGET. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT IT WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A SECOND COIL. THE SECOND COIL WAS PLACED AND DETACHED. A THIRD COIL, A 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0410 / 31567754) WAS INTRODUCED INTO THE ANEURYSM, AND THIS THIRD COIL WAS ALSO UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL CONCOMITANT MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 19-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE PROCEDURE WAS A STENT-ASSISTED EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM. THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; BOTH COILS WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS. THERE WAS NO EVIDENCE OF ANY BLOOD FLOW RESTRICTION / INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623555 ↗
• MalfunctionApr 23, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (COMPETITOR BRAND) WAS IN PLACE AND THE 2MM X 4CM ORBIT GALAXY HELICAL XTRASOFT (640CX0410 / 31382004) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED THE COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT. ON 10-APR-2025, IT WAS REPORTED THAT ADDITIONAL INFORMATION RELATED TO THE REPORTED DEVICE ISSUE IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895953 ↗
• InjuryNov 28, 2022Stretched; Stretched

  IT WAS REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TO TREAT A POSTERIOR COMMUNICATING ARTERY (PCA) ANEURYSM THAT WAS COMPRESSING CRANIAL NERVES RESULTING IN PATIENT INABILITY TO OPEN THE EYES NORMALLY, THE PHYSICIAN STARTED FILLING THE ANEURYSM WITH AN ORBIT GALAXY XTRASOFT CMPLX XTRASOFT COIL 4X10 (CATALOG 640CX0410/LOT 30656413) AND FELT SOME RESISTANCE. AT THIS MOMENT, IT WAS FOUND THAT THE COIL WAS PREMATURELY DETACHED AND WAS IN AN UNRAVELED/STRETCHED STATUS. THE PHYSICIAN IMMEDIATELY PULLED BACK THE COIL SLIGHTLY AND USED A STENT RETRIEVER (HEARTCARE) TO REMOVE THE COIL COMPLETELY. THE PHYSICIAN CONTINUED THE PROCEDURE BY USING ANOTHER ORBIT GALAXY XTRASOFT CMPLX XTRASOFT COIL 4X10 (CATALOG 640CX0410/LOT 30651727) BUT THIS COIL WAS ALSO FOUND TO BE UNRAVELED/STRETCHED DURING PLACEMENT. IT WAS STATED THAT THE PHYSICIAN SECURED THIS COIL BETWEEN THE STENT AND THE VESSEL WALL WITH A STENT (UNKNOWN DEVICE DETAILS) AND THEN COMPLETED THE SURGERY. THE PROCEDURE WAS PROLONGED FOR ABOUT 40 MINUTES AND THE PATIENT WAS STABLE. PROCEDURAL IMAGES WERE RETURNED FOR ANALYSIS AND ARE CURRENTLY PENDING REVIEW BY SR. MEDICAL AFFAIRS DIRECTOR. NO FURTHER INFORMATION WAS P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869123 ↗
• InjuryNov 28, 2022Stretched; Difficult to Advance; Premature Separation; Stretched; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TO TREAT A POSTERIOR COMMUNICATING ARTERY (PCA) ANEURYSM THAT WAS COMPRESSING CRANIAL NERVES RESULTING IN PATIENT INABILITY TO OPEN THE EYES NORMALLY, THE PHYSICIAN STARTED FILLING THE ANEURYSM WITH AN ORBIT GALAXY XTRASOFT CMPLX XTRASOFT COIL 4X10 (CATALOG: 640CX0410/LOT: 30656413) AND FELT SOME RESISTANCE. AT THIS MOMENT, IT WAS FOUND THAT THE COIL WAS PREMATURELY DETACHED AND WAS IN AN UNRAVELED/STRETCHED STATUS. THE PHYSICIAN IMMEDIATELY PULLED BACK THE COIL SLIGHTLY AND USED A STENT RETRIEVER (HEARTCARE) TO REMOVE THE COIL COMPLETELY. THE PHYSICIAN CONTINUED THE PROCEDURE BY USING ANOTHER ORBIT GALAXY XTRASOFT CMPLX XTRASOFT COIL 4X10 (CATALOG: 640CX0410/LOT: 30651727) BUT THIS COIL WAS ALSO FOUND TO BE UNRAVELED/STRETCHED DURING PLACEMENT. IT WAS STATED THAT THE PHYSICIAN SECURED THIS COIL BETWEEN THE STENT AND THE VESSEL WALL WITH A STENT (UNKNOWN DEVICE DETAILS) AND THEN COMPLETED THE SURGERY. THE PROCEDURE WAS PROLONGED FOR ABOUT 40 MINUTES AND THE PATIENT WAS STABLE. PROCEDURAL IMAGES WERE RETURNED FOR ANALYSIS AND ARE CURRENTLY PENDING REVIEW BY SR. MEDICAL AFFAIRS DIRECTOR. NO FURTHER INFORMATION W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869085 ↗
• MalfunctionMay 7, 2022Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THERE WAS RESISTANCE REPORTED WHILE ADVANCING THE 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0410 / 30432548) INSIDE THE CONCOMITANT ECHELON¿ 10 MICROCATHETER (MEDTRONIC) AT THE PROXIMAL SHAFT OF THE MICROCATHETER. IT WAS REPORTED THAT PRIOR TO THE ISSUE WITH THE COMPLAINT COIL, OTHER ORBIT GALAXY COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER; CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO DAMAGE OBSERVED ON THE COIL. WHEN THE MICROCATHETER WAS REMOVED, THERE WAS NO DAMAGE NOTED ON THE MICROCATHETER. EXCESSIVE FORCE WAS NOT APPLIED TO THE COMPLAINT DEVICE. THE REPORTED ISSUE RESULTED IN A 5-MINUTE DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. DURING THE MICROSCOPIC INSPECTION, THE COIL WAS OBSERVED TO BE IN A STRETCHED CONDITION. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 06-MAY-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324553 ↗
• MalfunctionMar 24, 2022Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM) , THE PHYSICIAN TRIED TO INSERT THE 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0410 / 30432548) THROUGH THE HUB OF THE SL-10® MICROCATHETER (STRYKER) AND HE ENCOUNTERED RESISTANCE AT THE HUB. THE PHYSICIAN MADE A FEW MORE ATTEMPTS TO ADVANCE THE COIL BUT STILL ENCOUNTERED RESISTANCE AT THE HUB. AS A RESULT, HE REMOVED THE COIL AND COMPLETED THE CASE WITH TARGET COILS. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AND EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0410 / 30432548), THE EMBOLIC COIL COMPONENT WAS OBSERVED IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON (B)(6) 2022, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13876684 ↗
• MalfunctionJan 24, 2022Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0410 / 30522110) WAS IMPEDED IN THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). THE PHYSICIAN RETRACTED THE DEVICES AND OBSERVED THAT THE DELIVERY WIRE OF THE COMPLAINT COIL WAS DEFORMED. THE GUIDING CATHETER, A 6F, 100 CM ENVOY® GUIDING CATHETER (67025800 / 30461480) WAS OBSERVED KINKED. THE PHYSICIAN REPLACED THE COIL AND THE GUIDING CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 20-JAN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA). INFORMATION RELATED TO THE CONCOMITANT MICROCATHETER USED WAS NOT AVAILABLE. THERE WAS AN ADEQUATE AND CONTINUOUS FLUSH MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE KINKS NOR OTHER DAMAGES WERE OBSERVED ON THE MICROCATHETER. THE MICROCATHETER WAS REMOVED WITH THE COIL; THE ADDITIONAL INFORMATION INDICATED THAT THE DELIVERY WIRE WAS DEFORMED. THE REPORTED EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13335472 ↗
• MalfunctionAug 19, 2020Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 4X10 OG CMPLX XTRASOFT COIL (640CX0410, 30201506) COULDN'T BE RETURNED TO THE INTRODUCER. THE PHYSICIAN ADVANCED THE 4X10 OG CMPLX XTRASOFT COIL THROUGH THE SAME HEADWAY-17 MICROCATHETER (MC) THAT WAS USED WITH A PRIOR COIL THAT WAS IMPLANTED IN THE ARTERIAL ANEURYSM. SECOND COIL (4X10 OG CMPLX XTRASOFT) ARRIVED AT THE ARTERIAL ANEURYSM WITH A ¿LITTLE BIT RESISTANCE¿ AND THE PHYSICIAN WAS NOT SATISFIED WITH THE SHAPE. SO HE PLANNED TO RETURN IT TO INTRODUCER AND SHAPE IT ONCE MORE. HOWEVER, THE COIL COULDN'T BE RETURNED TO INTRODUCER. PHYSICIAN WITHDREW THE COIL SYSTEM WITH Y-CONNECTOR TOGETHER. THE MICROCATHETER WAS NOT WITHDRAWN. THE PHYSICIAN USED ANOTHER BRAND COIL TO COMPLETE THE PROCEDURE. THE TARGET CEREBRAL POSITION WAS NOT LOST. THERE WAS NO INJURY REPORT. THE PROCEDURE WAS PROLONGED BY LESS THAN 15 MINUTES DUE THE EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL WAS SHAPED THE SAME AS THE ONE LISTED ON THE PACKAGE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE COIL WAS REMOVED NORMALLY FROM THE PATIENT. THE DELIVERY GUIDE WIRE OF THE COIL WAS RETRACTED WHILE THE MICROCATHETER WAS KEPT FIXED, BUT IT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426472 ↗
• MalfunctionApr 17, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM, THE PHYSICIAN STATED THAT THE 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0410 / 30013551) BECAME STRETCHED IN THE ANEURYSM NECK DURING ADVANCEMENT INTO THE ANEURYSM. THE COIL WAS REMOVED FROM THE PATIENT AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT DELAY. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED; NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THERE WAS NO KINK ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO COIL ENTANGLEMENT THAT COULD HAVE CONTRIBUTED TO THE EVENT; NO ADDITIONAL DAMAGE TO THE COIL OTHER THAN THE STRETCHED CONDITION REPORTED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. THE PRODUCT IS REPORTED AS AVAILABLE TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524995 ↗
• InjuryJan 18, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE THAT TARGETED A WIDE NECK (NECK WIDTH NOT REPORTED) ANEURYSM THAT MEASURED 4.32MM X 4.23MM ON THE ANTERIOR COMMUNICATING ARTERY (ACA), AFTER THE GUIDEWIRE (SYNCHRO 0.014¿, STRYKER) AND THE MICROCATHETER (ECHELON¿ 10, MEDTRONIC) REACHED THE TARGET LESION, THE 4 MM X 10 CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0410 / 30003310) COIL WAS SUCCESSFULLY IMPLANTED AND FORMED THE ¿BASKET SHAPE.¿ DUE TO THE LONG STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY, ONLY THE SIDE APPROACH COULD BE SELECTED TO TREAT THE ACA ANEURYSM. THE RIGHT ANTERIOR BRAIN WAS COMPENSATED BY THE ACA. AFTER PLACING THE COIL AT THE TARGET LESION FOR ABOUT 10 MINUTES TO DETERMINE WHETHER THE CONTRALATERAL ANTERIOR CEREBRAL ARTERY WOULD BE BLOCKED, ANGIOGRAPHY SUGGESTED CONTRALATERAL ANTERIOR CEREBRAL ARTERY OCCLUSION, AND THE COIL WAS WITHDRAWN. DURING THE RECOVERY OF THE COIL, IT UNRAVELED IN THE MICROCATHETER AND WAS REMOVED WITH NO ADDITIONAL INTERVENTION REQUIRED. THERE WAS NO LOSS OF CEREBRAL TARGET SITE POSITION, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT INJURY OR PROCEDURE DELAY. THE PROCEDURE WAS CONDUCTED

  Patient problems: Obstruction/Occlusion

  MAUDE report 8262934 ↗
• MalfunctionMay 9, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE ORBIT GALAXY XTRASOFT COIL 4 X 10 (640CX0410 / 17618512) COULD NOT BE ADVANCED IN THE MICROCATHETER. THE COIL WAS WITHDRAWN AND IT WAS OBSERVED STRETCHED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THE REPORTED EVENT DID NOT RESULT IN ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7501336 ↗