ORBIT GALAXY XTRASOFT 640CX3505Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704030683), received between Jul 26, 2017 and Nov 13, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 12 most recent of 12 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 18121567 ↗
• MalfunctionAug 15, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3.5X5 ORBIT GALAXY XTRASOFT COIL (640CX3505, 30706309) WAS BEING USED AS THE THIRD COIL. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225744 ↗
• MalfunctionApr 29, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3.5X5 ORBIT GALAXY XTRASOFT COIL (640CX3505, 30656414) WAS BEING AS A 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 THE ANEURYSM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250625 ↗
• MalfunctionApr 13, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE PHYSICIAN TRIED TO DEPLOY A 3.5X5 ORBIT GALAXY XTRASOFT COIL (640CX3505, 30498213) THROUGH AN ECHELON 10 MICROCATHETER (MC). HOWEVER, WHILE MID-WAY WHILE ADVANCING THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER FEW ATTEMPTS, THE DOCTOR REMOVED THE COIL AND DEPLOYED A COMPETITOR¿S COIL OF THE SAME SIZE AND PROCEEDED WITH THE CASE. IT WAS NO NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION INDICATED THAT THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE DEVICE DID NOT APPEAR DAMAGED 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 ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS OBSERVED TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103470 ↗
• MalfunctionMar 21, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3.5X5 ORBIT GALAXY XTRASOFT (640CX3505, 30526765) WAS BEING USED AS A 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 COIL'S SIZE IS NOT APPROPRIATE WITH ANEURYSM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. BASED ON THE DEVICE ANALYSIS OF THE DEVICE RECEIVED THE EMBOLIC COIL WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840086 ↗
• MalfunctionDec 27, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3.5MM X 5.0CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3505 / 30606921) WAS THE THIRD COIL CHOSEN; THE COIL COULD NOT BE ADVANCED NOR RETRACTED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, THE COMPLAINT COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. THE PHYSICIAN USED ¿A SAME LIKE¿ PRODUCT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13089167 ↗
• MalfunctionJun 1, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3.5X5 ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3505, 30465913) 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. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913043 ↗
• MalfunctionFeb 18, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, A 3.5X5 OG CMPLX XTRASOFT COIL (640CX3505, 30396176) WAS BEING USED AS A SECOND COIL. THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL FIRST. WHEN THE PHYSICIAN TRIED TO RESHEATH THE ORBIT GALAXY COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. BASED ON THE PRODUCT INVESTIGATION ON THE DEVICE RECEIVED, THE EMBOLIC COIL FOUND WITH A STRETCH CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342972 ↗
• MalfunctionJul 31, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 3.5MM X 5.0CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3505 / 30367473) WAS THE FIRST COIL CHOSEN; IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED NOR RETRACTED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER THE COIL WAS REMOVED, INSPECTION WAS PERFORMED, AND THE COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. THE PHYSICIAN USED ANOTHER 3.5MM X 5.0CM ORBIT GALAXY COMPLEX XTRASOFT COIL AS A REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10353370 ↗
• MalfunctionMar 7, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE ORBIT GALAXY COMPLEX XTRASOFT 3.5 MM X 5.0 CM COIL (640CX3505 / 17685002), THE COIL INTRODUCER ON THE DEVICE COULD NOT BE RESHEATHED / RE-ZIPPED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE EVENT; THERE WAS NO PROCEDURAL DELAY AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION IS NOT AVAILABLE. THE PRODUCT WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 2/28/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8399951 ↗
• MalfunctionAug 22, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A RUPTURED IC-PC ANEURYSM, AN ORBIT GALAXY ((B)(4)) WAS DIFFICULT TO POSITION AND KICKED BACK AND COULD NOT BE RE-SHEATHED BECAUSE THE ZIPPER BECAME STUCK, AND ORBIT GALAXY ((B)(4)) WAS OUT FROM THE LESION, BUT DID NOT PROTRUDE INTO THE PARENT VESSEL AND COULD NOT BE RE-SHEATHED BECAUSE THE ZIPPER BECAME STUCK. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER DUE TO THE EVENTS. 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 IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE VESSEL WAS NOT TORTUOUS OR CALCIFIED. AN SL 10 MICROCATHETER WAS USED FOR THE PROCEDURE. THE PRODUCTS ARE NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6809715 ↗
• MalfunctionJul 26, 2017Crack; Crack

  AS REPORTED BY A HEALTHCARE PROFESSIONAL AN ORBIT GALAXY COIL (640CX3505/ 17482875) HAD HUB BROKEN ISSUE WHEN THE BOX WAS OPENED, AND DURING ANALYSIS IS WAS CONFIRMED THAT THE HUB WAS CRACKED, AND ANOTHER ORBIT GALAXY COIL (640CF0410/16044774) HAD DELIVERY WIRE KINK DURING ADVANCING THE COIL INTO THE EXCELSIOR SL10 MICROCATHETER. FOR THE FIRST COIL, WHEN THE BOX WAS OPENED, THE PROXIMAL HUB WAS BROKEN. IT WAS REPORTED THAT THE DEVICE WAS PACKAGED AS EXPECTED AND THE PACKAGING DID NOT APPEAR DAMAGED. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN USED ANOTHER SAME SIZE COILS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO POTENTIAL ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6744016 ↗