GALAXY G3 GLX123509Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704077671), received between Dec 7, 2016 and Oct 25, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 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.

• InjuryOct 25, 2024Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A 41-YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES AND PREVIOUS SMOKING, PRESENTED WITH AN UNRUPTURED ANEURYSM, AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION ON (B)(6) 2023. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM ON THE LEFT BIFURCATION ANTERIOR CIRCULATION: INTERNAL CAROTID ARTERY (ICA): HEIGHT: 4.0MM, DOME: 4.7MM, MAXIMUM ANEURYSM DIAMETER: 4.7MM, NECK SIZE: 1.9MM, AND DOME-TO-NECK RATIO: 2.5MM. THE PARENT VESSEL DIAMETER WAS 3.4MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE GALAXY G3 XSFT 3.5MM X 9CM (GLX123509 / 30637474) VIA A HEADWAY 17 MICROCATHETER (MICROVENTION). HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COIL WAS SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO DEVICE DEFICIENCIES. ON (B)(6) 2023, THE PATIENT WAS DISCHARGED HOME FOR SELF-CARE WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0. ON (B)(6) 2024, THE PATI

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534360 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY (CNV_2017_01), A 49-YEAR-OLD MALE (SUBJECT (B)(6)) WITH NO RELEVANT MEDICAL HISTORY, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, WITH A MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2023. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.8MM, DOME 7MM, MAXIMUM ANEURYSM DIAMETER 8.2MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH EIGHT (8) CERENOVUS COILS: A GALAXY G3 6MM X 15CM (GLY120615/30715066), A GALAXY G3 XSFT 2.5MM X 3.5CM (GLX122535/30563820), A GALAXY G3 MINI 2MM X 3CM (GLM920030/30878377), A GALAXY G3 XSFT 4MM X 8CM (GLX120408/30901816), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/30719529), A GALAXY G3 XSFT 3.5MM X 9CM (GLX123509/30571102), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/30526863), AND A GALAXY G3 MINI 2MM X 4CM (GLM920040/30830570) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED IN THE

  Patient problems: Aneurysm

  MAUDE report 19448200 ↗
• MalfunctionJan 31, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 3.5MM X 9CM (GLX123509, 30526862) WAS USED AS THE SECOND COIL. THE COIL COULD NOT 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. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616196 ↗
• InjurySep 20, 2022Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2022, DURING A PULSERIDER STENT-ASSISTED COIL EMBOLIZATION WITH THE TARGET ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA), A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) WAS DELIVERED TO THE TARGET REGION AND DEPLOYED. THE PHYSICIAN ATTEMPTED TO FRAME THE ANEURYSM BY USING A 4MM X 8CM MICRUSFRAME 14 COIL (MFR140408 / LOT# UNKNOWN). HOWEVER, THE COIL DID NOT FIT WELL, SO THE COIL WAS REMOVED FROM THE PATIENT¿S BODY. ON THE SECOND ATTEMPT, THE PHYSICIAN ATTEMPTED TO COMPLETE THE FRAMING BY CHANGING THE MICROCATHETER SHAPE AND THE COIL SIZE / TYPE WITH THE FOLLOWING COILS: A 3.5MM X 9CM GALAXY G3 XSFT (GLX123509 / LOT# UNKNOWN), A 3MM X 8CM HYDROSOFT® COIL (MICROVENTION-TERUMO), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / LOT# UNKNOWN). HOWEVER THESE COILS ALSO DID NOT FIT WELL SO THEY WERE REMOVED FROM THE PATIENT¿S BODY. IN ADDITION, THE PHYSICIAN ALSO NOTICED THAT THE DEPLOYED PULSERIDER ANRD DID NOT SUFFICIENTLY COVER THE ANEURYSM NECK, THEREFORE, THE PHYSICIAN ALSO REMOVED THE PULSERIDER ANRD. ON THE THIRD ATTEMPT, THE PHYSICIAN TRIED THE BALLOON-ASSIST TECHNIQUE. THE PHYSI

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15456500 ↗
• MalfunctionJul 1, 2022Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3.5MM X 9CM GALAXY G3 XSFT (GLX123509 / 30371937) WAS STRETCHED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14894235 ↗
• InjuryJul 7, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE STERLING 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 19-SEP-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 10239789 ↗
• InjuryDec 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A CONTACT AT THE USER FACILITY THAT DURING STENT ASSISTED COILING OF AN UNRUPTURED 6 X 4.5 MM MIDDLE CEREBRAL ARTERY ANEURYSM IN A (B)(6) PATIENT RESISTANCE WAS EXPERIENCED WHEN USING TWO GALAXY COILS (GLX123509/S11635 AND GLY120620/S11514). AFTER SUCCESSFULLY PLACING 23 MM ENTERPRISE 2 STENT, THE SURGEON PLACED A PROWLER LPES MICROCATHER (606S155FX/16068713) INTO THE ANEURYSM. A 5X15 GALAXY G3 COIL WAS DECIDED TO BE PLACED. AFTER SUCCESSFULLY PLACING AND DETACHING THE COIL, THE SURGEON DECIDED TO PLACE A 3.5X9 G3 XTRASOFT COIL (LOT# S11635). UPON INTRODUCING THE COIL INTO THE LPES IT WAS NOTED THAT THERE WAS A FAIR AMOUNT OF RESISTANCE PUSHING THE COIL THROUGH THE MICROCATHETER. HE WAS HOWEVER ABLE TO SUCCESSFULLY PLACE AND DETACH THIS COIL. AT THIS TIME THE SURGEON WAS SATISFIED WITH THE OCCLUSION OF THE ANEURYSM AND PULLED THE LPES OUT INTO M1. UPON FINAL ANGIOGRAM A SLIGHT EXTRAVASATION IN THE M3 TO M4 DISTRIBUTION WAS NOTICED. THE SURGEON DECIDED AT THAT TIME TO TEMPORARILY OCCLUDE THE M1 WITH A 6X20 GALAXY G3 (LOT# S11514) AND TRIED TO ADVANCE THE COIL INTO THE MC BUT IT WOULD NOT ADVANCE. AFTER A COUPLE OF TRIES THE SURGEON ASKED FOR GALAXY 6X20 FILL (640C

  Patient problems: Extravasation

  MAUDE report 6151064 ↗