ORBIT GALAXY 640CR0930Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886704030461), received between Sep 25, 2018 and Jan 20, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ORBIT GALAXY COIL (PRODUCT CODE: 640CR0930, LOT NUMBER: 31359782) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO A NON-J&J MICROCATHETER (MC). THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW NON-J&J COIL TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURIES NOR CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. A RUIKANGTONG 17 SYSTEM MICROCATHETER WAS USED. THE DEVICES DID NOT APPEAR PHYSICALLY DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE INTRODUCER. A CONTINUOUS FLUSH WAS MAINTAINED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE COIL IS NOTED TO BE MECHANICALLY DETACHED FROM THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121371 ↗
• MalfunctionSep 3, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, AN UNSPECIFIED MICROCATHETER WAS IN PLACE AND AN ORBIT GALAXY COIL (640CR0930, 31557208) 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 TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 19-AUG-2025 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THERE WAS NECK REMODELING USED WITH A STENT. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE EMBOLIC COIL DID NOT STRETCH OR BECAME DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951855 ↗
• MalfunctionApr 28, 2025Stretched; Positioning Problem; Stretched; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL SHAPE OF A 9X30 ORBIT GALAXY (640CR0930, 31300997) WAS FOUND NOT IDEAL AFTER IT WAS FILLED IN THE ANEURYSM. THE DOCTOR RETRACTED THE COIL AND THEN REMOVED THE COIL AND MICROCATHETER (NON-J&J) FROM THE PATIENT, BUT THE COIL WAS FOUND UNRAVELED/STRETCHED. THE DOCTOR SWITCHED TO A NEW COIL (NON-J&J) TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 16-APR-2025 INDICATED THAT THERE WERE NO DIFFICULTIES POSITIONING THE COIL IN THE ANEURYSM, POSITIONING WAS ACCURATE. HOWEVER, THERE WAS DIFFICULTY GETTING THE COIL TO CONFORM TO THE ANEURYSM WALL, NOT IDEAL SHAPE. THERE WAS VESSEL TORTUOSITY, WIDE NECK AND HUGE ANEURYSM. THE 10 MINUTES PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919226 ↗
• MalfunctionMay 21, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE BASILAR ARTERY, AN ORBIT GALAXY COIL (640CR0930, 31053583) BECAME IMPEDED IN THE MIDDLE SECTION OF THE PROLWER SELECT 14 MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2024 INDICTED THAT THERE APPEARED TO BE NO DAMAGE TO THE DEVICE. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359924 ↗
• MalfunctionJan 12, 2024Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE WHILE PUSHING TWO 9MM X 30CM ORBIT GALAXY COMPLEX FRAME COILS (640CR0930) BOTH FROM LOT 30957434 IN THE MICROCATHETER. THE COILS WERE REMOVED. THE PROCEDURE WAS DELAYED BY 10 MINUTES; THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 26-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. THERE WERE NO REMARKABLE ANATOMICAL / VESSEL CHARACTERISTICS SUCH AS VESSEL CALCIFICATION AND/OR TORTUOSITY. THE MICROCATHETER USED WAS A PROWLER SELECT LPES MICROCATHETER (606S155X / 31041133). PER THE ADDITIONAL INFORMATION, THE REPORTED RESISTANCE AS FIRST FELT DURING ADVANCEMENT OF THE DEVICE INSIDE THE CONCOMITANT MICROCATHETER AT MID-SHAFT. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. PRIOR TO THE REPORTED RESISTANCE, A 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030 / 30856382) WAS SUCCESSFULLY USED WITH THE MICROCATHETER. THE MICROCATHETER WAS REMOVED WHEN THE RESISTANCE WAS ENCOUNTERED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509062 ↗
• MalfunctionJan 12, 2024Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE WHILE PUSHING TWO 9MM X 30CM ORBIT GALAXY COMPLEX FRAME COILS (640CR0930) BOTH FROM LOT 30957434 IN THE MICROCATHETER. THE COILS WERE REMOVED. THE PROCEDURE WAS DELAYED BY 10 MINUTES; THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 26-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. THERE WERE NO REMARKABLE ANATOMICAL / VESSEL CHARACTERISTICS SUCH AS VESSEL CALCIFICATION AND/OR TORTUOSITY. THE MICROCATHETER USED WAS A PROWLER SELECT LPES MICROCATHETER (606S155X / (B)(6)). PER THE ADDITIONAL INFORMATION, THE REPORTED RESISTANCE AS FIRST FELT DURING ADVANCEMENT OF THE DEVICE INSIDE THE CONCOMITANT MICROCATHETER AT MID-SHAFT. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. PRIOR TO THE REPORTED RESISTANCE, A 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030 / (B)(6)) WAS SUCCESSFULLY USED WITH THE MICROCATHETER. THE MICROCATHETER WAS REMOVED WHEN THE RESISTANCE WAS ENCOUNTERED. THE INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509047 ↗
• MalfunctionSep 23, 2023Material Separation; Failure to Advance; Material Separation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 9MM X 30CM ORBIT GALAXY COMPLEX FRAME OF THE SAME PRODUCT CODE: (640CR0930 / 30706306) BECAME IMPEDED IN THE MIDDLE SECTION OF THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED THE COIL AND FOUND THE DEVICE BROKEN INTO TWO PIECES. THE PHYSICIAN USED A MICRO GUIDEWIRE TO REMOVE THE REMAINING PORTION OF THE COIL INSIDE THE MICROCATHETER. A NEW COIL WAS USED AS REPLACEMENT TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 15-SEP-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE REQUESTED THAT THE EVENT DESCRIPTION BE UPDATED AS FOLLOWS: DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 9MM X 30CM ORBIT GALAXY COMPLEX FRAME OF THE SAME PRODUCT CODE (640CR0930 / 30706306) BECAME IMPEDED IN THE MIDDLE SECTION OF THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN REMOVED THE COIL AND MICROCATHETER FROM THE PATIENT FOR INSPECTION AND FOUND THAT THE COIL BROKE INTO TWO (2) PIECES. THE PHYSICIAN THEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804843 ↗
• MalfunctionAug 17, 2023Material Separation; Difficult to Advance; Material Twisted/Bent; Material Separation; Difficult to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE FOLLOWING COILS WERE USED: THE HYPOTUBE OF THE FIRST COIL, A 9MM X 30MM ORBIT GALAXY COMPLEX FRAME COIL (640CR0930 / 30706306) REPORTEDLY BROKE WHILE ¿PUSHING THE COIL THROUGH THE CATHETER.¿ ANOTHER COIL, A 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0202 / 30868860) COULD NOT BE RESHEATHED. ON 10-AUG-2023, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PROCEDURE WAS TARGETING AN ANEURYSM ON THE MIDDLE CEREBRAL ARTERY (MCA). THE HYPOTUBE OF THE 9MM X 30MM ORBIT GALAXY COMPLEX FRAME COIL (640CR0930 / 30706306) BECAME KINKED, THEN FRACTURED INTO TWO WHILE THE COIL WAS BEING PUSHED THROUGH THE MICROCATHETER. THE 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0202 / 30868860) HAD POSITIONING DIFFICULTY WHICH PROMPTED THE REPORTED FAILED ATTEMPT TO RESHEATH. THERE WAS RESISTANCE DURING THE ADVANCEMENT OF BOTH COILS THROUGH THE MICROCATHETER, THE RESISTANCE WAS AT THE MID-SHAFT OF THE MICROCATHETER. THE INFORMATION INDICATED THAT NECK REMODELING WAS NOT USED. THE MICROCATHETER WAS LEFT IN PLACE AND THE COILS WERE REPLACED. THE PROCEDURE WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568499 ↗
• MalfunctionSep 6, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN ANEURYSM IN THE ANTERIOR CEREBRAL ARTERY (ACA), A 9X30 ORBIT GALAXY COIL (640CR0930, 30692749) BECAME IMPEDED IN A NON-J&J MICROCATHETER (MC) AND COULD NOT PASS THROUGH IT. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW COIL TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE MICROCATHETER WAS REPLACED DURING THE OPERATION, AND THE COIL STILL COULD NOT PASS THROUGH. THE DEVICE DID NOT APPEAR TO BE DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361972 ↗
• MalfunctionFeb 7, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY (ACOM), THERE WAS RESISTANCE ENCOUNTERED WITH AN ORBIT GALAXY COIL (640CR0930, 30341955) WHILE PUSHING THE COIL IN THE ECHELON 10 MEDTRONIC MICROCATHETER (MC). THE SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT. THE COIL WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COMPLAINT COIL ANOTHER TWO COILS WERE DEPLOYED IN THE PATIENT. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. 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 FOUND STRETCHED AND THE DELIVERY TUBE (HYPO TUBE) WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472079 ↗
• MalfunctionSep 25, 2018Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ORBIT GALAXY COMPLEX FRAME 9MM X 30CM COIL (640CR0930/17726077) BECAME DETACHED IN THE MICROCATHETER WHILE THE PHYSICIAN WAS MANIPULATING IT. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT. THE PRODUCT IS AVAILABLE TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907951 ↗