ORBIT GALAXY 640CF0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704030218), received between Mar 24, 2017 and Nov 3, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE START OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE DEVICE PACKAGE OF THE 3MM X 6CM ORBIT GALAXY MINI COMPLEX FILL COIL (640CF0306 / 31577253) WAS INSPECTED AND CONFIRMED TO BE IN GOOD CONDITION. DURING THE PROCEDURE, WHEN THE COIL WAS BEING USED TO FILL THE TARGET ANEURYSM, IT WAS FOUND THAT THE COIL WAS UNABLE TO BE ¿ROTATED RANDOMLY, AND THE SHAPE OF THE COIL WAS NOT IDEAL.¿ THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH ANOTHER COIL FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE WITH THE SAME ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 02-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET VESSEL / LOCATION O THE ANEURYSM BEING TREATED WAS THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). PHOTOS OF THE COIL AFTER IT WAS REMOVED FROM THE PATIENT ARE NOT AVAILABLE. NO DAMAGE WAS OBSERVED ON THE COIL WHEN IT WAS REMOVED. THE CONCOMITANT MICROCATHETER WAS AN ECHELON¿ 14 MICROCATHETER (MEDTRONIC). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT ON THE PATIENT AND NO DELAY IN THE PROCEDURE DUE TO THE REPORTED ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452725 ↗
• MalfunctionSep 2, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A MICROCATHETER (OTHER BRAND) WAS IN PLACE AND A ORBIT GALAXY COIL (640CF0306, 31168615) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A SECOND NEW COIL AND DETACHED SUCCESSFULLY. THEN THE DOCTOR DELIVERED THE THIRD COIL, A ORBIT GALAXY XTRASOFT (640HX0206, 31444522) BUT IT FAILED TO DETACH. THE DOCTOR ONLY RETRACTED THE THIRD COIL ALONE AND SWITCHED TO A FOURTH COIL, AN ORBIT GALAXY XTRASOFT (640HX0206, 31492321) WHICH HAD THE SAME ISSUE. THE DOCTOR ONLY RETRACTED THE FOURTH COIL ALONE AND SWITCHED A FIFTH COIL (OTHER BRAND) TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-AUG-2025 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED WITH EACH COIL. THE SAME DCB WAS USED SUCCESSFULLY WITH THE SUBSEQUENT COILS. ENTERPRISE VASCULAR RECONSTRUCTION STENTS WERE USED TO ASSIST ANEURYSM EMBOLIZATION. THE COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COILS DID NOT STRETCH OR DAMAGED WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937891 ↗
• MalfunctionDec 11, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT DEVICE, A 3MM X 6CM ORBIT GALAXY MINI COMPLEX FILL (640CF0306 / 30937878) WAS IMPEDED AT THE DISTAL END OF THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE COIL AND OBSERVED THAT IT HAD UNRAVELED / STRETCHED. A NEW COIL WAS USED AS REPLACEMENT 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 18307764 ↗
• InjuryNov 30, 2023Entrapment of Device; Material Separation; Migration; Entrapment of Device; Material Separation; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, A 4MM X 23MM NO TIP ENTERPRISE¿ 2 VASCULAR RECONSTRUCTION DEVICE (ENCR402300 / 8470639) WAS PARTIALLY RELEASED. AFTER ABOUT 1/3 OF THE COIL, A 3MM X 6CM ORBIT GALAXY MINI COMPLEX FILL (640CF0306 / 31047856) FILLED IN THE ANEURYSM, THE COIL WAS FOUND TO BE SEPARATED INTO TWO PIECES, WHILE THE REST OF THE COIL WAS MOVED TO THE DISTAL END OF THE PARENT VESSEL. THE PHYSICIAN USED A GUIDEWIRE (UNSPECIFIED BRAND) TO CAPTURE THE COIL. IT WAS FOUND THAT THE STENT POSITION HAD MIGRATED. THE TWO SEPARATED PIECES OF THE COIL, THE STENT AND THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31085109) WERE WRAPPED TOGETHER. THE PHYSICIAN USED AN INTERMEDIATE CATHETER (UNSPECIFIED BRAND) TO REMOVE THE COIL, THE STENT, AND THE MICROCATHETER FROM THE PATIENT AND SWITCHED TO COMPETITOR DEVICES TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A MIDDLE CEREBRAL ARTERY BLEED. SURGICAL DRILLING AND DRAINAGE WAS INITIALLY PERFORMED AND THEN TRANSFERRED TO A CRANIOTOMY DUE TO EXCESSIVE BLEEDING.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 18240760 ↗
• MalfunctionMay 26, 2017Premature Activation; Premature Activation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT AN ENTIRE OG CMPLX FILL COIL 3X6 (640CF0306/17463106) PREMATURELY DETACHED IN A PROWLER SELECT LP/ES MICROCATHETER (606S155X/LOT UNKNOWN) DURING A COIL EMBOLIZATION PROCEDURE OF A CEREBRAL ANEURYSM. THE COIL HAD NOT BEEN ADVANCED OUT OF THE TIP OF THE MICROCATHETER AT ALL, THEREFORE EVERYTHING WAS REMOVED FROM THE PATIENT. REPORTEDLY, RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT OF THE COIL THROUGH THE MID PORTION OF THE MICROCATHETER. THERE WAS NO DAMAGE NOTED TO THE COIL PRIOR TO USE AND NO KINKS WERE NOTED ON THE MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. ONE COMPLEX FILL 6MM X 20CM (640CF0620) WAS SUCCESSFULLY USED WITH THE PROWLER SELECT LP/ES MICROCATHETER PRIOR TO THE REPORTED EVENT. THE PATIENT¿S INFORMATION AND ANEURYSM CHARACTERISTICS ARE UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE REPORTED EVENT AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER AND COIL. THE PATIENT¿S STATUS POST PROCEDURE IS UNKNOWN. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AS IT WAS DIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6594723 ↗
• MalfunctionMar 24, 2017Premature Activation; Premature Activation

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE, THE COIL INTRODUCER OF AN ORBIT GALAXY 3X6 FILL COIL WAS DAMAGED AND ANOTHER ORBIT GALAXY 3X6 FILL COIL PREMATURELY DETACHED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM FOR SUBARACHNOID HEMORRHAGE AT THE ANTERIOR COMMUNICATING ARTERY. THE OG CMPLX FILL (COMPLAINT PRODUCT1) WAS USED FOR FRAMING, THE PHYSICIAN TRIED TO RE-SHEATH THE COIL BUT SHEATH INTRODUCER AND DELIVERY WIRE SPLIT OPEN AND THE COIL COULD NOT BE RE-SHEATHED. THE COIL WAS REPLACED WITH ANOTHER OG CMPLX FILL (COMPLAINT PRODUCT2). THE COIL WAS DELIVERED INTO THE MICRO CATHETER BUT THE COIL DETACHED IN THE CATHETER; THEREFORE, THE MICRO CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED BY 10 MINUTES. 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 A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO (AND AFTER) THE EVENT. THE PRODUCTS WILL BE RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION IS AV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6432446 ↗