ORBIT GALAXY XTRASOFT 640HX0208Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704030737), received between Apr 5, 2018 and Dec 28, 2023 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE WHILE PUSHING THE 2MM X 8CM ORBIT GALAXY HELICAL XTRASOFT COIL (640HX0208 / 30843069) IN THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). WHEN REMOVED, IT BECAME STRETCHED. THE PROCEDURE WAS DELAYED BY 5 MINUTES DUE TO THE REPORTED ISSUE. THE DEFECTIVE COIL WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT. ON 26-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET WAS A 5MM X 4MM POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM. NECK REMODELING WAS NOT USED. THE CONCOMITANT MICROCATHETER WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER, THERE WAS RESISTANCE IN THE MID-SHAFT OF THE MICROCATHETER. PRIOR TO THE REPORTED ISSUE WITH THE COMPLAINT COIL, TWO OTHER ORBIT GALAXY COILS DID GO THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THERE WERE NO KINKS ON THE MICR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414409 ↗
• MalfunctionDec 5, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, TWO (2) COILS WERE DELIVERED TO THE MICROCATHETER ¿SMOOTHLY,¿ THEN THE PHYSICIAN DELIVERED THE THIRD COIL, A 2MM X 8CM ORBIT GALAXY HELICAL XTRASOFT COIL (640HX0208 / 30615107) TO THE MICROCATHETER BUT FELT SOME RESISTANCE. THE PHYSICIAN THEN TRIED TO RETRACT THE COIL; THE COIL WAS STILL IMPEDED IN THE MICROCATHETER. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN RETRACTED THE COIL AND OBSERVED THAT IT HAD BECOME UNRAVELED / STRETCHED. A NEW COIL WAS USED AS REPLACEMENT WITH THE SAME ORIGINAL MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY. TWO PHOTOS OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT. ONE OF THE DEVICE PACKAGING AND ONE OF THE COMPLAINT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15919349 ↗
• MalfunctionSep 8, 2022Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN PUSHED A 2X8 ORBIT GALAXY XTARSOFT COIL (640HX0208, 30562631) OUT FOR INSPECTION AND OBSERVED THAT THE DISTAL END OF THE COIL AUTOMATICALLY PREMATURELY DETACHED FROM THE SIDE OF THE PROTECTIVE SHEATH. THE SURGERY WAS DONE WITH A NEW SPRING COIL. THE PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378295 ↗
• MalfunctionAug 18, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, ORBIT GALAXY XTRASOFT COIL (640HX0208, 30620254) BECAME IMPEDED IN THE UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANYMORE. THE PHYSICIAN RETRACTED THE COIL AND FOUND IT WAS UNRAVELED/STRETCHED. A NEW COIL WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249309 ↗
• MalfunctionApr 5, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2X6 ORBIT GALAXY COIL (640HX0206, 30574615) COULD NOT BE DETACHED, THE PHYSICIAN RAISED PRESSURE TO RED AREA, BUT THE COIL STILL COULD NOT DETACH. THE SECOND COIL, A 2X8 GALAXY XTRASOFT COIL (640HX0208, 30546086) HAD THE SAME ISSUE. THE THIRD DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014875 ↗
• MalfunctionSep 10, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE THE ORBIT GALAXY HELICAL XTRASOFT 2MM X 8CM COIL (640HX0208 / 17710996) COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE COIL WAS REMOVED, AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7862978 ↗
• MalfunctionApr 5, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ORBIT GALAXY HELICAL XTRASOFT COIL 2X8 (640HX0208 / 17673406) BECAME STRETCHED DURING THE EMBOLIZATION PROCEDURE. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7401415 ↗