ORBIT GALAXY XTRASOFT 640CX0406Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886704030621), received between Sep 21, 2018 and Nov 13, 2023 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Failure to Advance; Contamination /Decontamination Problem; Failure to Advance; Contamination /Decontamination Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640CX0406, 30692754) AND AN ORBIT GALAXY XTRASOFT COIL (640CX3505, 30706309) BECAME STUCK INTO A PROWLER SELECT LPES MICROCATHETER (606S155X, 31041133). IT WAS ALSO NOTED THAT THERE IS A THREAD INSIDE THE PACKING OF THE COIL. THE PROCEDURE WAS DELAYED BY 30 MINUTES. THE DEVICES WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. A NEW COIL AND MICROCATHETER (MC) WERE USED TO COMPETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121550 ↗
• MalfunctionSep 5, 2023Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 4MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0406 / 30651725) WAS IMPEDED IN THE DISTAL END OF THE CONCOMITANT MICROCATHETER, A 150CM X 5CM, 2 MARKERS PROWLER SELECT LPES (606S155X / 30763317) AND COULD NOT PASS THROUGH. THE PHYSICIAN ENCOUNTERED SIGNIFICANT RESISTANCE. THE PHYSICIAN REMOVE THE COIL AND MICROCATHETER FROM THE PATIENT¿S ANATOMY AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT BOTH DEVICES WERE OBSERVED TO BE KINKED / BENT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS A LOBULATED ANEURYSM (ANEURYSM SIZE WAS UNOBTAINABLE) ON THE INTERNAL CAROTID ARTERY (ICA). A 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. THERE WAS SIGNIFICANT RESISTANCE WHEN THE COIL WAS APPROACHING THE TIP OF THE MICROCATHETER. NO OTHER COIL WENT THROUGH THE MICROCATHETER PRIOR TO THE COMPLAINT COIL. THE ISSUE REPORTED OCCUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684890 ↗
• MalfunctionJun 5, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFTCOIL (640CX0406, 30790724) WAS BEING USED AS THE SECOND COIL IN THE PROCEDURE. HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060437 ↗
• MalfunctionMar 8, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE IN A PATIENT WHO WAS SUFFERING FROM A RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATING ANEURYSM WITH THE ANEURYSM BEING 4MM X 5.1MM IN SIZE. THE 4MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0406 / 30386797) WAS USED; THE PHYSICIAN OBSERVED THAT THE COIL WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED OUT. THE PHYSICIAN ATTEMPTED TO RETRACT IT SLIGHTLY AND PUSHED IT AGAIN BUT STILL FELT THE RESISTANCE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT. ON 04-FEB-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COMPLAINT COIL WAS USED WITH THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC). THE INFORMATION INDICATED THAT NO OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. IT WAS NOT KNOWN IF THE MICROCATHETER WAS REMOVED WHEN THE COIL WAS REPLACED. THERE WAS NO DAMAGE ON THE MICROCATHETER DURING THE MANIPULATION OF THE DEVICE OR NOTICED AFTER IT WAS REMOVED. CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691275 ↗
• InjuryFeb 28, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: HAYASHI, NAOKI & KAWANISHI, MASAHIKO & SHINDO, ATSUSHI & OKUBO, SHUICHI & OSAKA, NAOHIRO & OSAKA, KUNIHIKO & TAMIYA, TAKASHI. (2019). A RUPTURED INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH PURE ACUTE SUBDURAL HEMATOMA AND OCULOMOTOR PALSY WITHOUT SUBARACHNOID HEMORRHAGE: A LITERATURE REVIEW SURGERY FOR CEREBRAL STROKE. 47. 373-380. 10.2335/SCS.47.373. OBJECTIVE AND METHODS: THIS ARTICLE PRESENTS A CASE OF PURE ACUTE SUBDURAL HEMATOMA (ASDH) CAUSED BY INTRACRANIAL ANEURYSM RUPTURE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 4MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL. CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 7F LAUNCHER GUIDING CATHETER (MEDTRONIC); 4MM X 7MM HYPERFORM BALLOON (MEDTRONIC); EXCELSIOR SL-10 MICROCATHETER (STRYKER); 360 SOFT COILS (STRYKER); TARGET 360 ULTRA COILS (STRYKER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: A (B)(6) FEMALE WHO UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTUR

  Patient problems: Aneurysm

  MAUDE report 13621140 ↗
• InjuryFeb 24, 2022Stretched; Stretched

  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 13595137 ↗
• MalfunctionOct 23, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 4MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0406 / 30441961) WAS THE FIRST COIL USED. THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. AS A RESULT, THE PHYSICIAN REMOVED THE COIL, AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION POST REMOVAL, THE COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. THE PHYSICIAN USED ANOTHER 4MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10727910 ↗
• MalfunctionMar 3, 2020Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 4X6 OG CMPLX XTRASOFT COIL (640CX0406, 30165279) COULD NOT ADVANCE IN THE Y CONNECTOR. THE PHYSICIAN WITHDREW THE UNIT TOGETHER FROM THE PATIENT. THERE WAS PATIENT INJURY REPORTED. THE DEVICE WAS NOT ABLE TO MOVE AT ALL DUE TO THE RESISTANCE. THE USER WAS NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE RESISTANCE WAS FELT IN THE BODY OF THE PRODUCT. NO OTHER DEVICES WERE USED SUCCESSFULLY WITH THE CONCOMITANT DEVICE AFTER THE ENCOUNTERED RESISTANCE. THE OG CMPLX XTRASOFT COIL NOR THE CONCOMITANT DEVICE KINKED OR BENT PRIOR TO THE RESISTANCE OR NOTED AFTER REMOVAL FROM THE PATIENT. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9779753 ↗
• InjurySep 21, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF), THE ORBIT GALAXY COMPLEX XTRASOFT 4MM X 6CM COIL (640CX0406 / 30075872) WAS CHOSEN AS THE FIRST COIL, AS THE ANCHORING COIL. THE ORBIT GALAXY COIL WAS PLACED WITHOUT ANY ISSUE BUT WHEN THE ATTEMPT WAS MADE TO DETACH THE COIL WITH THE DCS SYRINGE AT LEVEL 3, THE COIL DID NOT DETACH. THE PRESSURE ON THE DCS SYRINGE WAS RAISED TO 4 AND THE PHYSICIAN THOUGHT THAT THE COIL DETACHED AND PULLED THE COIL, BUT THE COIL WAS NOT DETACHED, AND IT HAD TO BE REMOVED USING A SNARE DEVICE. THE COIL WAS NOT STRETCHED OR BECOME ENTANGLED. IT WAS CONFIRMED THAT THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY OR ISSUE. IT WAS ALSO CONFIRMED THAT THE SYRINGE PRESSURIZED AS INTENDED. THE ORBIT GALAXY COIL WAS REPLACED WITH A COMPETITOR¿S PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898333 ↗