GALAXY G3 GLX120206Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886704077756), received between Jul 7, 2020 and Dec 9, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION TARGETING A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, THE COIL MICROCATHETER (COMPETITOR BRAND) WAS IN PLACE AND THE 2MM X 6CM GALAXY G3 XSFT HELICAL (GLX120206 / 30803128) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN INSPECTED THE INDICATOR LIGHT OF THE DETACHMENT CONTROL BOX AND CONNECTOR CABLE AND OBSERVED THAT ALL WERE IN GOOD CONDITION. THE PHYSICIAN PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT IT STILL FAILED TO DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL TO REPLACE IT WITH ANOTHER COIL TO COMPLETE THE ANEURYSM FILLING. THE PHYSICIAN THEN DELIVERED THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 8994884) VIA THE STENT MICROCATHETER (COMPETITOR BRAND). THE STENT WAS IMPEDED IN THE DISTAL END OF THE MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED BOTH STENT AND MICROCATHETER FROM THE PATIENT¿S ANATOMY AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE, WHICH WAS DELAYED BY APPROXIMATELY 10 MIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887561 ↗
• MalfunctionMay 23, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A GALAXY G3 XSFT HEL 2MM X 6CM COIL (GLX120206, 30803130) WAS IMPEDED AT THE DISTAL END OF THE MICROCATHETER (OTHER BRAND) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE COIL WAS FOUND UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL OUT OF THE PATIENT AND SWITCHED A NEW COIL TO DETACH IT SUCCESSFULLY AT THE TARGET SITE. THEN THE PHYSICIAN DELIVERED AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8337178) TO THE TARGET SITE AND STARTED TO RELEASE IT, 3 DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT EXPAND AS EXPECTED. THE PHYSICIAN RETRACTED THE STENT OUT OF THE PATIENT¿S BODY AND REPLACED IT WITH A NEW STENT TO COMPLETE THE PROCEDURE. THE COILING MICROCATHETER AND THE STENTING MICROCATHETER WERE NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-MAY-2024 INDICATED THAT THEY WERE NOT ABLE TO MOVE THE COIL AT ALL. THEY WERE NOT ABLE TO MOVE THE COIL AT ALL DUE TO THE RESISTANCE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. IT IS POSSIBLE THAT EXCESSIVE FORCE WAS USED WITH THE COIL. THERE WAS DIFFICULTY REMOVING THE COIL FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382413 ↗
• MalfunctionJan 30, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A GALAXY G3 XSFT HEL 2MM X 6CM COIL ((B)(6)). IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610126 ↗
• MalfunctionJan 30, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A GALAXY G3 XSFT HEL 2MM X 6CM COIL (GLX120206, 30772776). IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610042 ↗
• MalfunctionJan 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 2MM X 6CM GALAXY G3 XSFT HELICAL (GLX120206 / 30742440) FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509248 ↗
• MalfunctionNov 26, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 2MM X 6CM GALAXY G3 XSFT HELICAL COIL (GLX120206 / 30772776) WAS USED TO FILL THE ANEURYSM. THE PHYSICIAN TRIED TO DETACH THE COIL BUT THE DETACH CYCLE LIGHT DID NOT ILLUMINATE. THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND SWITCHED TO A NEW COIL. DURING DETACHMENT OF THE REPLACEMENT, COIL, THE DETACH CYCLE LIGHT ILLUMINATED NORMALLY AND THE COIL DETACHED. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 15 MINUTES. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. ON 20-NOV-2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. WHEN THE COIL WAS REMOVED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. CLARIFICATION TO THE REPORTED DESCRIPTION OF DEVICE DAMAGE WAS ALSO RECEIVED ¿ ¿THE DETACH CYCLE LIGHT CANNOT ILLUMINATE NORMALLY.¿ THE FAULT LIGHT WAS NOT SEEN DURING THE CASE. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT DID NOT ILLUMINATE AND THE AUDIBLE SIGNAL BEEP WAS NOT HEARD. ALL CONNECTIONS FIT WITHOUT APPLICATION OF EXCESSIVE FORCE. THE PHYSICIAN DID NOT CONSIDER THE 15-MINUTE PROCEDURE EXTENSION TO BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207796 ↗
• MalfunctionNov 4, 2023Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, WHEN THE THIRD COIL, A 3MM X 8CM GALAXY G3 MINI (GLM930080 / 30865692) WAS USED TO FILL THE ANEURYSM, THE COIL WAS FOUND TO BE UNRAVELED / STRETCHED. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND) FROM THE PATIENT AND SWITCHED TO A NEW COIL, A 2MM X 6CM GALAXY G3 XSFT HELICAL (GLX120206 / 30579193) AND A NEW MICROCATHETER (COMPETITOR BRAND). THE REPLACEMENT COIL WAS ALSO FOUND TO BE UNRAVELED / STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT AGAIN TO COMPLETE THE PROCEDURE; THE REPLACEMENT MICROCATHETER WAS NOT REPLACED. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 30 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. TWO PHOTOS WERE INCLUDED IN THE COMPLAINT. ON 25-OCT-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PATIENT IS A 67-YEAR-OLD FEMALE WITH A HISTORY OF HYPERTENSION. THE TARGET ANEURYSM WAS A 4MM X 5MM IRREGULAR ANEURYSM. NECK REMODELING DEVICE WAS NOT USED. AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC) WAS USED, BUT THE PHYSICIAN SWITCHED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070378 ↗
• MalfunctionApr 12, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VESSEL SACRIFICE PROCEDURE OF THE LINGUAL ARTERY, THE COMPLAINT COIL, A 2MM X 6CM GALAXY G3 XSFT HELICAL (GLX120206 / 30478874) FAILED TO DETACH. IT WAS REPORTED THAT PRIOR TO THE USE OF THE COIL, THE TECHNOLOGIST TESTED IT BY CONNECTING THE ENPOWER CONTROL CABLE TO THE HUB OF THE COIL. A GREEN LIGHT WAS OBSERVED ON THE ENPOWER DETACHMENT BOX PRIOR TO USE. THE COIL WAS THEN INTRODUCED BY THE PHYSICIAN INTO THE ROTATING HEMOSTASIS VALVE (RHV) AND SEATED INTO THE MICROCATHETER HUB. THE COIL WAS HYDRATED WITH SALINE AND WEEPING FROM THE INTRODUCER SHEATH WAS OBSERVED BEFORE IT WAS ADVANCED. WHEN THE COIL FAILED TO DETACH, MULTIPLE ENPOWER CONTROL CABLE (ECB00018200) FROM THE FOLLOWING LOTS: 30739198, 30798739, AND 30810538, AS WELL AS BOTH ENPOWER DETACHMENT BOXES (CATALOG AND LOT NUMBERS NOT PROVIDED) WERE USED TO TROUBLESHOOT THE FAILED DETACHMENT. THE COMPLAINT COIL AND THE THREE ENPOWER CONTROL CABLES WILL BE RETURNED FOR INVESTIGATION INTO THE FAILED DETACHMENT. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED, HOWEVER, THE DURATION OF THE DELAY IS UNKNOWN. THE REASON FOR THE DELAY WAS FOR THE PHYSICIAN TO REGAIN ACCESS TO THE LESI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726424 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A (B)(6) FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF ACTIVE SMOKING AND INTRACRANIAL ANEURYSM UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2021 AND EXPERIENCED INTRAOPERATIVE ANEURYSM PERFORATION. BALLOON OCCLUSION WAS PERFORMED AS INTERVENTION, AND THE EVENT REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT IS RECOVERING FROM THE EVENT. THE EVENT WAS CLASSIFIED AS SEVERE. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS RELATED TO THE STUDY DEVICE. THE EVENT WAS CONSIDERED SERIOUS.

  Patient problems: Aneurysm

  MAUDE report 13010234 ↗
• InjuryJul 7, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE (B)(6) STUDY, A (B)(6) YEAR OLD MALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES AND SMOKING (CURRENT) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2019, AND EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6) 2020, REQUIRING REPEAT COIL EMBOLIZATION ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RIGHT PCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.8MM, DOME 9.6MM, MAXIMUM ANEURYSM DIAMETER 9.6MM, NECK SIZE 5.0MM, AND DOME-TO-NECK RATIO 1.9MM. PARENT VESSEL DIAMETER WAS 2.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L13627), ONE 3.5MM X 9CM GALAXY G3 XSFT (GLX123509/L12045), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408/L13272), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L13817), ONE 5MM X 10CM GALAXY G3 (GLY120510/L13038), ONE 6MM X 11.9CM MICRUSFRAME10 (MFR100611/L15887), ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/L15266), ONE 9MM X 22CM MICRUSFRAME14 (MFR140922/L15601), ONE 2MM X 6CM GALAXY G3 XSFT HEL (GLX120206/L11700), AND ONE 2MM X 8CM GALAXY G3 XSFT HEL (GLX

  Patient problems: No Code Available

  MAUDE report 10239894 ↗