GALAXY G3 GLY120925Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886704077596), received between Feb 6, 2018 and Oct 31, 2025 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 9MM X 25CM GALAXY G3 COIL (GLY120925 / 1352561S) FAILED TO DETACH FROM ITS DELIVERY SYSTEM. IT WAS REPORTED THAT TO COMPLETE THE PROCEDURE, THE PHYSICIAN USED A NEW DEVICE ¿OF THE SAME TYPE.¿ THERE WAS NO NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439186 ↗
• MalfunctionMar 15, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THERE WAS AN ISSUE WITH UNSHEATHING GALAXY G3 9MM X 25CM COIL (GLY120925, 30778052). THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED THE COIL WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545695 ↗
• InjuryJul 11, 2022Entrapment of Device; Stretched; Positioning Problem; Entrapment of Device; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED BASILAR ARTERY TIP ANEURYSM VIA THE TRANS-CELL TECHNIQUE, AN 8FR SLIM GUIDE® (MEDIKIT CO, LTD) WAS INTRODUCED INTO THE LEFT SUBCLAVIAN ARTERY, AND A SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION) WAS INTRODUCED FROM THE LEFT VERTEBRAL ARTERY (VA) TO THE PROXIMAL BASILAR ARTERY (BA). THE HEADWAY® DUO MICROCATHETER (MICROVENTION) WAS PLACED NEAR THE LEFT VA UNION, AND THE HEADWAY® 27 MICROCATHETER (MICROVENTION) WAS PLACED UNDER THE ANEURYSM NECK. AFTER THE INTRODUCTION OF THE PULSERIDER 10T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D/3069219303) VIA THE HEADWAY® 27 MICROCATHETER AND EXTERNALLY EXPANDING THE BILATERAL POSTERIOR CEREBRAL ARTERY (PCA), THE HEADWAY® 27 MICROCATHETER MADE AN APPROACH INTO THE ANEURYSM VIA TRANS-CELL TECHNIQUE. THE COMPLAINT COIL, A 9MM X 25CM GALAXY G3 (GLY120925/30715068) WAS INTRODUCED VIA THE HEADWAY® DUO MICROCATHETER AS THE FIRST COIL. WHEN THE COIL WAS INSERTED TO THE DETACHMENT MARKER, IMAGING WAS PERFORMED FOR CONFIRMATION. THERE WAS A GAP IN THE ANEURYSM WALL, AND THE PHYSICIAN ATTEMPTED TO RESHEATH THE COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981930 ↗
• InjuryJun 14, 2022Deformation 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 BY THE STERLING STUDY, A 64-YEAR-OLD FEMALE PATIENT (SUBJECT (B)(4)) WITH A HISTORY OF DIABETES, CONTROLLED HYPERTENSION, BEING A PREVIOUS SMOKER, DEPRESSION, HEPATITIS C, AND CHRONIC BACK PAIN, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) SACCULAR ANEURYSM WITH MODIFIED RANKIN SCALE (MRS) SCORE 2 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 11.5MM, DOME 9.8MM, MAXIMUM ANEURYSM DIAMETER 10.8MM, NECK SIZE 7.1MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.5MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/ L16383), A GALAXY G3 6MM X 10CM (GLY120610/L13911), A GALAXY G3 6MM X 15CM (GLY120615/K10645), A GALAXY G3 6MM X 20CM (GLY120620/L14866), A GALAXY G3 8MM X 24CM (GLY120824/30530863), GALAXY G3 7MM X 15CM (GLY120715/L15636), GALAXY G3 9MM X 25CM (GLY120925/L13514), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/304943930, A GALAXY G3 XSFT 3MM X 4CM (GLX120304/30370440), AND A 2.5MM X 4MM GALAXY G3 XTRASOFT (30371932). THREE (3) NON- CERENOVUS COILS WERE USED: TWO TARGET 360 ULTRA AND ONE TARGET 360 NANO (ALL STRYKER). A NEUROFORM ATLAS

  Patient problems: Aneurysm

  MAUDE report 14687253 ↗
• MalfunctionApr 25, 2022Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A STENT-ASSISTED CEREBRAL COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACA), THE NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS USED. THE COMPLAINT COIL, A 9MM X 25CM GALAXY G3 (GLY120925 / 30692226) WAS INSERTED IN THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER) DURING CONTINUOUS FLUSH. THE COMPLAINT COIL GOT STUCK IN THE MICROCATHETER DURING INSERTION. THE PHYSICIAN FELT THAT IT WAS NOT NORMAL SO THE COMPLAINT COIL WAS PULLED FROM THE MICROCATHETER AND IT WAS REPORTED THAT THE COMPLAINT COIL ¿SEEMED CUTTING OFF INSIDE THE MICROCATHETER.¿ WHEN THE COMPLAINT COIL WAS REMOVED FROM THE MICROCATHETER, IT WAS DETACHED FROM THE TIP OF THE DELIVERY WIRE AND REMAINED INSIDE THE MICROCATHETER. THE MICROCATHETER WAS REPLACED AND THE EMBOLIZATION WAS COMPLETED USING OTHER COILS. THE REPORTED EVENT HAD NO EFFECT ON THE PATIENT. THERE WAS NO PATIENT INJURY OR COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196420 ↗
• InjuryJul 21, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF UNCONTROLLED HYPERTENSION AND ACTIVE SMOKING UNDERWENT COIL EMBOLIZATION OF A RUPTURED WIDE-NECKED LEFT POSTERIOR CEREBRAL ARTERY (PCA) ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 3) ON (B)(6) 2019. AT THE 180-DAY (6-MONTH) FOLLOW-UP VISIT ON (B)(6) 2020, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. ON (B)(6) 2020, THE PATIENT SUBSEQUENTLY UNDERWENT A BALLOON-ASSISTED COIL EMBOLIZATION DUE TO INCREASE IN ANEURYSM SIZE. A TOTAL OF 19 COMPETITOR COILS WERE IMPLANTED WITH MODIFIED RAYMOND-ROY SCORE OF CLASS IIIB. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY. ON (B)(6) 2019, IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED POSTERIOR CIRCULATION ANEURYSM ON THE LEFT SIDE WALL OF THE PCA WITH THE FOLLOWING DIMENSIONS: HEIGHT 8.7MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 11.1MM, NECK SIZE 6.0MM, AND DOME-TO-NECK RATIO 1.9MM.

  Patient problems: Aneurysm

  MAUDE report 12207733 ↗
• MalfunctionDec 17, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET AT THE INTERNAL ILIAC ARTERY, AN ECHELON¿ MICROCATHETER (MEDTRONIC) WAS DELIVERED TO THE TARGET AND THE EMBOLIZATION PROCEDURE STARTED. A CERENOVUS COIL WAS USED AS THE FIRST COIL; THIS COIL SUCCESSFULLY IMPLANTED. THE COMPLAINT COIL, A 9MM X 25CM GALAXY G3 COIL (GLY120925 / L15757) WAS THE SECOND COIL USED. IT WAS REPORTED THAT THE INTRODUCER SHEATH BECAME SPLIT WHEN THE DELIVERY WIRE WAS BEING ADVANCED. THE PHYSICIAN ATTEMPTED TO KEEP IT ADVANCED, BUT IT WAS DIFFICULT, AND THE COIL WAS REPLACED WITH ANOTHER SAME SIZED COIL (COIL BRAND WAS NOT REPORTED) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED STRETCHED. BASED ON THE PRODUCT ANALYSIS (B)(6) 2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11031834 ↗
• InjuryNov 20, 2020Migration; Migration

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, THE (B)(6) FEMALE PATIENT WITH A HISTORY OF CONTROLLED HYPERLIPIDEMIA, CONTROLLED HYPERTENSION, SMOKING (CURRENT), AND INTRACRANIAL ANEURYSMS (TOTAL OF 3) PRESENTED WITH A SUBARACHNOID HEMORRHAGE (SAH) SECONDARY TO RUPTURED ANEURYSM (HUNT & HESS GRADE 2) AND SUBSEQUENTLY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED ANEURYSM ON THE LEFT SIDEWALL OF THE INTERNAL CAROTID ARTERY (ICA): HEIGHT: 10MM, DOME: 12MM, MAXIMUM ANEURYSM DIAMETER: 17MM, NECK SIZE: 7.8MM, AND DOME-TO-NECK RATIO: 1.5MM. THE PARENT VESSEL DIAMETER WAS 5.8MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF THE FOLLOWING COILS: A 14MM X 47CM MICRUSFRAME18 COIL (MFR181447 / L10314), A 11MM X 37CM MICRUSFRAME18 COIL (MFR181137 / L10312), A 10MM X 30CM GALAXY G3 COIL (GLY121030 / L11083), AND A 9MM X 25CM GALAXY G3 COIL (GLY120925 / L10732) VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). AN 8MM X 24CM GALAXY G3 COIL (GLY120824 / L15747) WAS USED BUT NOT IMPLANTED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STU

  Patient problems: Aneurysm; No Code Available; Thromboembolism

  MAUDE report 10880609 ↗
• InjurySep 21, 2020Migration; Migration

  A REPORT FROM THE FIELD INDICATED THAT DURING A BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) ARTERY ANEURYSM, A 9MM X 25CM GALAXY G3 (GLY120925/UNKNOWN LOT #) WAS INSERTED AND DETACHED AS THE FRAMING COIL VIA AN SL-10 (STRYKER) MICROCATHETER. NEXT, UNSPECIFIED IED (KANEKA) AND GALAXY G3 COILS WERE UTILIZED FOR FILLING AND FINISHING. ONE OF THE PREVIOUSLY PLACED COIL LOOPS SUBSEQUENTLY PROTRUDED INTO THE PARENT VESSEL RESULTING IN THE NEED FOR STENT-ASSISTED COILING. THE SCEPTER C (TERUMO) BALLOON CATHETER WAS REMOVED FROM THE PATIENT AND A PROWLER SELECT PLUS (UNKNOWN PRODUCT CODE & LOT #) MICROCATHETER WAS DELIVERED TO THE MIDDLE CEREBRAL ARTERY (MCA). A 4MM X 23MM ENTERPRISE 2 NO TIP (ENC402300/11138626) STENT WAS INSERTED INTO THE PROWLER SELECT PLUS MICROCATHETER. THE PHYSICIAN ATTEMPTED TO IMPLANT THE STENT, BUT HE COULD NOT SEE THE MARKER. ALTHOUGH THE INSIDE OF THE SKULL INCLUDING THE DISTAL PART OF THE MCA WAS PHOTOGRAPHED, THERE WAS NO APPARENT SIGN THAT THE STENT WAS IMPLANTED. IT HAD NOT DEPLOYED AT THE Y-CONNECTOR. THE PHYSICIAN SUSPECTED THAT THE COMPLAINT DEVICE DID NOT HAVE A MARKER, SO HE STARTED TO REMOVE THE

  Patient problems: No Code Available

  MAUDE report 10560570 ↗
• InjuryApr 1, 2020Deformation 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 BY THE STERLING STUDY, A (B)(6)-YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF CARDIAC ARRHYTHMIA, DIABETES, CONTROLLED HYPERLIPIDEMIA, AND CONTROLLED HYPERTENSION, UNDERWENT COIL EMBOLIZATION OF A RUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2018 AND EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6) 2019 REQUIRING RETREATMENT ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2018 REVEALED AN ANTERIOR CIRCULATION ANEURYSM ON RIGHT SIDEWALL OF THE POSTERIOR COMMUNICATING ARTERY. THE RUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.3MM, DOME 11.3MM, MAXIMUM ANEURYSM DIAMETER 11.9MM, NECK SIZE 4.4MM, AND DOME-TO-NECK RATIO 2.6MM. PARENT VESSEL DIAMETER WAS 3.9MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 9MM X 14CM MICRUSFRAME C (S11389), ONE 10MM X 30CM GALAXY G3 (L10166), ONE 9MM X 25CM GALAXY G3 (L10165), TWO 5MM X 15CM GALAXY G3 (L12691), TWO 4MM X 10CM GALAXY G3 (L12837), AND ONE 2MM X 6CM GALAXY G3 MINI (L12517) VIA A SL-10 (STRYKER) MICROCATHETER. TWO COILS FAILED TO UNSHEATHE PROPERLY (ONE 2MM X 6CM GALAXY G3 MINI - L12517 AND ONE 10MM X 16CM MICRUSFRAME14 ¿ S11391) AND WERE THEREFORE NOT IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 9911143 ↗
• MalfunctionJun 11, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ARTERIOVENOUS FISTULA (AVF) AT THE PULMONARY ARTERY, THE 9MM X 25CM GALAXY G3 COIL (GLY120925 / L13463) BECAME UNRAVELED INSIDE THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30090272). BOTH DEVICES WERE REMOVED TOGETHER FROM THE PATIENT¿S BODY. THE DEVICES WERE REPLACED, AND THE PROCEDURE COMPLETED SAFELY WITHOUT ANY PATIENT COMPLICATION OR ADVERSE EVENT. THE PRODUCT HAS BEEN RECEIVED AND IS PENDING EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689502 ↗
• MalfunctionDec 10, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE VENOUS FISTULA COILING PROCEDURE ON NORMAL VENOUS ANATOMY TARGETING THE TRANSVERSE SINUS, THE 9MM X 25CM GALAXY G3 COIL (GLY120925 / L10946) WAS REPORTED TO HAVE ISSUE ADVANCING FROM THE COIL INTRODUCER. THE COIL WAS FLUSHED AGAIN, BUT IT STILL DID NOT ADVANCE FROM THE COIL INTRODUCER. IT WAS REPORTED THAT THE END USER TRIED TO UNLOCK THE COIL FROM THE LOCKING TOOL, BUT THE COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER. THE COIL DID NOT ENTER THE MICROCATHETER (EXCELSIOR¿ SL-10¿, STRYKER). IT WAS CONFIRMED THAT THERE WAS NO DAMAGE NOTED ON THE GALAXY G3 COIL; NO BEND OR KINKS WERE NOTED ON THE MICROCATHETER. THE GALAXY G3 COIL WAS REMOVED FROM THE PATIENT BUT THE MICROCATHETER WAS LEFT IN THE PATIENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT CONSEQUENCE; THERE WAS NO PROCEDURAL DELAY ASSOCIATED WITH THE REPORTED ISSUE. THE 9MM X 25CM GALAXY G3 COIL IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8149164 ↗
• MalfunctionMay 4, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE INTERNAL CAROTID ARTERY, THE PHYSICIANS INTRODUCED THE GALAXY G3 9 MM X 25 CM COIL (GLY120925 / L10569) THROUGH A MICROCATHETER (EXCELSIOR SL 10 STRYKER). IT WAS SET UP FOR DEPLOYMENT BUT THE COIL FAILED TO DETACH. SEVERAL ATTEMPTS WERE MADE TO DETACH THE COIL USING THREE DIFFERENT CONNECTING CABLES AND TWO DIFFERENT DETACHMENT BOXES BUT THE ATTEMPTS WERE NOT SUCCESSFUL. BOTH DETACHMENT BOXES WERE CONFIRMED TO WORK. THE COIL WAS REMOVED FROM THE PATIENT AND THE PHYSICIANS ATTEMPTED TO CONNECT IT TO THE DELIVERY SYSTEM TO SEE IF IT WOULD DETACH OUTSIDE OF THE PATIENT BUT IT WAS DETERMINED THAT THE COIL COULD NOT BE CONNECTED TO THE DELIVERY SYSTEM; THE PART ON THE COIL THAT IS USED TO CONNECT TO THE CONNECTING CABLE WAS REPORTED TO BE DEFECTIVE. THE PHYSICIANS CHOSE ANOTHER COIL, A MICRUSFRAME10 8 MM X 29 CM (MRF100829 / L10132), THIS COIL WAS CHECKED AND DETERMINED TO HAVE NO ISSUE WITH BEING CONNECTED TO THE CABLE OR THE DETACHMENT BOXES. THEY DETERMINED THAT THE GALAXY G3 9 MM X 25 CM COIL (GLY120925 / L10569) COULD NOT BE DETACHED BECAUSE IT COULD NOT BE CONNECTED TO THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488882 ↗
• MalfunctionFeb 6, 2018Kinked; Kinked

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT TWO GALAXY G3 COILS (GLY120925/S11884 AND GLY120410/S11711) WERE USED DURING A PROCEDURE AND THE COILS COULD NOT BE RE-SHEATHED. NOTE: THIS EVENT WAS DEEMED REPORTABLE BASED ON THE DEVICE EVALUATION RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7244802 ↗