ORBIT GALAXY XTRASOFT 640CX0304Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886704030584), received between Dec 20, 2017 and Feb 8, 2024 — classified as 1 injury, 14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Separation Failure; Separation Failure

  COIL WAS NOT GETTING DETACHED WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 10 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED? DEFECTIVE PRODUCT REMOVED, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY: NO, (B)(6). DEVICE PROPERTY OF: EVALUATION, DEVICE IN POSSESSION OF: DISTRIBUTOR BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669047 ↗
• MalfunctionOct 6, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0304 / 31025931) WAS DELIVERED INTO THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND) AND IT PASSED THROUGH THE TIP OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS IMPEDED IN THE MICROCATHETER TIP AND COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892473 ↗
• MalfunctionSep 21, 2023Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT PRESENTING WITH A 3MM BASILAR BIFURCATION ANEURYSM UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE FIRST COIL USED TO FILL THE ANEURYSM WAS A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0304 / 31025931). IT WAS REPORTED THAT THE COIL WAS UNABLE TO ¿ROTATE RANDOMLY AND THE SHAPE OF THE COIL WAS NOT IDEAL.¿ THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A COMPETITOR BRAND TO COMPLETE THE PROCEDURE; THE MICROCATHETER (UNSPECIFIED BRAND) WAS NOT REPLACED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. TWO PHOTOS OF THE COIL WERE INCLUDED IN THE COMPLAINT. ON 11-SEP-2023, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CERENOVUS SALES REPRESENTATIVE. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS UNRUPTURED. THE MICROCATHETER USED WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). THERE WAS NO PATIENT INJURY OR PATIENT COMPLICATION AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795555 ↗
• MalfunctionJul 26, 2023Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR CEREBRAL ARTERY (ACA), AN ORBIT GALAXY XTRASOFT COIL (640CX0304, 30885231) FAILED TO RESHEATH. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF THE COIL TO BE RESHEATHED WAS DUE TO POOR CONFORMABILITY. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE UNSPECIFIED MICROCATHETER. NECK REMODELING WAS NOT UTILIZED. THE MICROCOIL WAS NOT POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396008 ↗
• MalfunctionApr 4, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE SECOND COIL, A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0304 / 30810800) AND THE FOURTH COIL, A 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 30722167) COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. IT WAS REPORTED THAT THE PHYSICIAN USED THE ¿SAME LIKE¿ PRODUCTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679052 ↗
• MalfunctionDec 12, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X4 ORBIT GALAXY XTRASOFT COIL (640CX0304, 30679277) BECAME IMPEDED IN THE DISTAL END OF THE UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANYMORE. THE COIL WAS RETRACTED, AND IT WAS FOUND TO BE UNRAVELED/STRETCHED. THE PHYSICIAN CHANGED TO A NEW COIL AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958917 ↗
• 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 14603813 ↗
• MalfunctionMar 3, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X4 ORBIT GALAXY XTRASOFT COIL (640CX0304, 30606918) WAS BEING USED AS A SECOND COIL. THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL FIRST. DURING RESHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN DECIDED TO PULL IT OUT BECAUSE THE COIL'S SIZE WAS NOT APPROPRIATE WITH ANEURYSM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS NOTED TO BE STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659816 ↗
• MalfunctionMar 2, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X4 ORBIT GALAXY XTRASOFT COIL (640CX0304, 30399118) WAS BEING USED AS THE FIRST COIL. THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL FIRST. DURING RESHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN DECIDED TO PULL IT OUT BECAUSE THE COIL'S SIZE IS NOT APPROPRIATE WITH ANEURYSM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652635 ↗
• MalfunctionFeb 24, 2022Premature Separation; Premature Separation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION IN A MALE PATIENT, A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0304/30615573) WAS FOUND TO BE PREMATURELY DETACHED WHEN THE PACKAGE WAS OPENED, PRIOR TO USE. THE 4MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0406/30562629) BECAME STRETCHED DURING DEPLOYMENT OF THE COIL IN THE MCA, WHICH REQUIRED USE OF A SNARE FOR REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY. THE SURGERY WAS DELAYED 10-20 MINUTES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595157 ↗
• MalfunctionDec 16, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COL EMBOLIZATION, THE PHYSICIAN USED AN EXCELSIOR SL10 MICROCATHETER TO CANNULATE THE ANEURYSM AND DEPLOY A 3X4 ORBIT GALAXY XTRASOFT COIL (640CX0304, 30261288). WHILE ADVANCING THE COIL THROUGH THE SL10 MICROCATHETER (MC), THE PHYSICIAN NOTICED A RESISTANCE IN THE MIDWAY OF THE MC. AFTER A FEW ATTEMPTS, HE WITHDREW THE COIL THROUGH THE MC WITHOUT ANY PROBLEMS AND DEPLOYED SUCCESSFULLY A COMPETITOR¿S COIL WITH THE SAME MC. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO DAMAGE TO THE MC UPON REMOVAL FROM THE PATIENT. THE PRODUCT COMPLAINT WAS NOT DAMAGED IN ANY WAY AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE DEVICE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS SEVERELY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017588 ↗
• MalfunctionJan 12, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X4 OG CMPLX XTRASOFT COIL (640CX0304, 30215695) WAS BEING USED AS THE FIRST COIL. THE PHYSICIAN FELT STRONG RESISTANCE WHILE ADVANCING ORBIT GALAXY THROUGH A HEADWAY MICROCATHETER (MC). THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS FOUND WITH A STRETCH CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155594 ↗
• MalfunctionDec 15, 2020Difficult to Advance; Positioning Problem; Difficult to Advance; Positioning Problem

  AS REPORTED BY THE FIELD, DURING AN ANEURYSM EMBOLIZATION, A 3X4 OG CMPLX XTRASOFT COIL (640CX0304, 30341958) DID NOT TOUCH THE ARTERIAL ANEURYSM WHEN THE COIL ENTERED IT. SO, THE PHYSICIAN DIDN'T DETACH THE COIL AND WITHDREW IT BACK TO THE UNSPECIFIED MICROCATHETER (MC). THE USER PLANNED TO PULL BACK THE COIL SYSTEM OUTSIDE OF THE PATIENT'S BODY, BUT THE COIL IMPEDED IN THE MICROCATHETER (MC) WHEN IT WAS PULLED BACK. THEREFORE, THE PHYSICIAN PULLED BACK THE MICROCATHETER OUTSIDE OF THE PATIENT¿S BODY WITH THE COIL SYSTEM TOGETHER. THE CEREBRAL TARGET POSITION WAS LOST DUE TO THAT THE PHYSICIAN SWITCHED TO ANOTHER NEW COIL SYSTEM AND MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY REPORTED. THE ARTERIAL ANEURYSM OF THE PATIENT WAS NOT SPECIAL A NEW COIL (SAME TYPE AS THE COMPLAINT COIL) WORKED WELL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012578 ↗
• MalfunctionNov 10, 2020Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, STRONG RESISTANCE WAS FELT WHILE ADVANCING A 3X4 OG CMPLX XTRASOFT COIL (640CX0304, 30341958) THROUGH HEADWAY MICROCATHETER (MC). IT WAS PROXIMAL OF THE MC AREA. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THIS WAS THE FIRST COIL BEING USED. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817780 ↗
• MalfunctionDec 20, 2017Material Separation; Unraveled Material; Material Separation; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN INFANT¿S ABDOMINAL ARTIFICIAL VESSEL, AN ORBIT GALAXY (640CX0304/ 17478469) UNRAVELED AND POSSIBLY SEPARATED. A PLUG (AMPLATZER VASCULAR PLUG, ST. JUDE MEDICAL) WAS IMPLANTED AND THE COMPLAINT COIL WAS USED TO FILL THE GAP. WHEN THE COIL WAS BEING DEPLOYED, THERE WAS RESISTANCE FELT AS IF THE COIL PARTIALLY BECAME TANGLED WITH THE PLUG. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, BUT THE COIL UNRAVELED AND THE PHYSICIAN FELT THAT THE COIL WAS SEPARATED. THE COIL WAS REMOVED FROM THE PATIENT DESPITE DIFFICULTY. BY OBSERVING THE REMOVED COIL, IT WAS NOT POSSIBLE TO SEE IF IT WAS SEPARATED SINCE IT HAD BEEN UNRAVELED. THERE IS A POSSIBILITY THAT THE SEPARATED PART OF THE COIL REMAINS IN THE PATIENT, THEREFORE THE PHYSICIAN REQUESTED TO INVESTIGATE IF THE COIL WAS ACTUALLY SEPARATED. THE PROCEDURE WAS COMPLETED WITH IMPLANTING A NEW OG CMPLX XS (640CX0304). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. 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 CONSTAN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133508 ↗