GALAXY G3 GLY120410Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886704077473), received between Mar 4, 2019 and Mar 2, 2026 — classified as 4 injuries, 10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, A NON J&J MICROCATHETER WAS POSITIONED AT THE TARGET SITE, AND A GALAXY G3 4MM X 10CM COIL (PRODUCT CODE: GLY120410, LOT NUMBER: 1652406S) WAS DELIVERED INTO THE ANEURYSM. AFTER COIL DEPLOYMENT, DETACHMENT WAS ATTEMPTED; HOWEVER, THE COIL FAILED TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND NOTED THAT IT HAD BECOME UNRAVELED/STRETCHED. A SECOND COIL WAS INTRODUCED AND SUCCESSFULLY DETACHED. THE PHYSICIAN THEN PROCEEDED WITH STENT DEPLOYMENT USING AN ENTERPRISE2 4MMX23MM (PRODUCT CODE: ENCR402312, LOT NUMBER: 9751065) BUT OBSERVED THAT THE STENT¿S THREE DISTAL MARKERS WERE CONVERGED AND FAILED TO OPEN OR EXPAND AS INTENDED. THE STENT WAS RETRACTED AND REPLACED WITH A NEW STENT, WHICH DEPLOYED SUCCESSFULLY. THE MICROCATHETER REMAINED IN PLACE THROUGHOUT THE PROCEDURE AND WAS NOT REPLACED. THE OVERALL PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 10 MINUTES. NO PATIENT HARM WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-MAR-2026 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CONTROL CABLE WERE SUCCESSFUL WITH SUBSEQUENT COILS. THE EMBOLIC COIL WAS ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482713 ↗
• MalfunctionOct 31, 2024Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT WHILE THE 4MM X 10CM GALAXY G3 (GLY120410 / 30790697) WAS BEING PREPARED BEFORE INSERTION INTO THE MICROCATHETER, ¿THE PHYSICIAN EXPERIENCED THAT THE FLUSH WAS NOT DONE ENOUGH [DESPITE] SEVERAL TRIES OF FLUSHING THROUGH FLUSH HOLES. THE COIL WAS NOT DELIVERED SMOOTHLY, AND HE FELT STRONG RESISTANCE WHILE PUSHING THE COIL INTO THE SL-10® MICROCATHETER (STRYKER).¿ THE PHYSICIAN REMOVED THE COIL FROM THE MICROCATHETER AND REPLACED IT WITH A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN PRODUCT FOR ANALYSIS AND OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF PRODUCT IS RETURNED OR INFORMATION PROVIDED AT A LATER DATE, THE FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT FILE WAS REOPENED TO RECEIVE THE RETURNED PRODUCT. THE PRODUCT WAS RECEIVED ON 14-OCT-2024. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 31-OCT-2024, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582871 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY. THE 57-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEADACHES, PREVIOUS SMOKER, AND TRANSIENT ISCHEMIC ATTACK (TIA) IN 2017 PRESENTED WITH AN UNRUPTURED ANEURYSM. THE PATIENT UNDERWENT COIL EMBOLIZATION ON (B)(6) 2023. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM ON THE LEFT SIDEWALL ANTERIOR CIRCULATION: PARAOPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA): HEIGHT: 4.4MM, DOME: 5.2MM, MAXIMUM ANEURYSM DIAMETER: 5.2MM, NECK SIZE: 4.6MM, AND DOME-TO-NECK RATIO: 1.1MM. THE PARENT VESSEL DIAMETER WAS 4.3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF A 4MM X 10CM GALAXY G3 (GLY120410 / 30618614), A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30656499), AND A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30571099) VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). A FLOW DIVERTER, PIPELINE EMBOLIZATION DEVICE (MEDTRONIC), WAS ALSO IMPLANTED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLE

  Patient problems: Aneurysm

  MAUDE report 19274308 ↗
• MalfunctionFeb 27, 2023Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A 5MM ANTERIOR COMMUNICATING ARTERY (ACOM), A 4MM X 10CM GALAXY G3 COIL (GLY120410 / 30729912) WAS USED. IT WAS REPORTED THAT FRAMING WAS DIFFICULT; THEREFORE, THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL TO REPOSITION THE CONCOMITANT PHENOM¿ MICROCATHETER (MEDTRONIC), HOWEVER, RESHEATHING WAS NOT POSSIBLE AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16445003 ↗
• MalfunctionFeb 6, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, COIL EMBOLIZATION WAS PERFORMED BY SELECTING EACH BRANCH FROM MULTIPLE BRANCHES. IT IS UNKNOWN WHICH ARTERIES WERE TREATED. THE COMPLAINT COILS WERE USED FROM A MICROCATHETER (PHENOM) BUT RE-SHEATHING WAS IMPOSSIBLE. THE COMPLAINT COIL GALAXY G3 6MM X 15CM (GLY120615/ 30670813) WAS THE FIRST COIL AND ANOTHER COMPLAINT COIL GALAXY G3 4MM X 10CM (GLY120410/ 30628983) WAS THE SECOND COIL USED. ANOTHER G3 COIL (4MM X 10CM) WAS USED AS A REPLACEMENT COIL AND USED WITHOUT ANY PROBLEMS. ADDITIONAL EVENT INFORMATION STATES THAT NO DAMAGE WAS NOTED IN THE DEVICE. RESISTANCE WAS NOT FELT AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303246 ↗
• MalfunctionJul 29, 2021Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 4MM X 10CM GALAXY G3 COIL (GLY120410, L16071) WAS USED BUT IT BECAME UNRAVELED. THE COIL WAS REPLACED WITH ANOTHER COIL. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245042 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM IN A FEMALE PATIENT, A PULSERIDER 8T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3051697019) WAS ALLEGEDLY DEPLOYED AS PER THE INSTRUCTIONS FOR USE (IFU) IN A HYBRID POSITION FROM THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) TO THE ANEURYSM (I.E., PARTIALLY INTRAANEURYSMAL). A CONCOMITANT SL-10® MICROCATHETER (STRYKER) USED FOR COIL DELIVERY WAS ADVANCED TO THE ANEURYSM VIA TRANS-CELL APPROACH. A 4MM X 10CM GALAXY G3 COIL WAS USED BUT THE SIZE DID NOT FIT SO IT WAS REPLACED WITH A 3MM X 8CM GALAXY G3 COIL. HOWEVER, COIL WAS DEEMED TOO SMALL FOR THE ANEURYSM. THE COIL WAS REPLACED WITH A 3.5MM X 9CM GALAXY G3 COIL (GLY123509 / LOT#: UNKNOWN). THE COIL WAS REWINDED MULTIPLE TIMES, BUT IT WAS NOT ABLE TO FRAME THE ANEURYSM AS INTENDED. THE COIL WAS REPLACED WITH A 3MM X 6CM COMPETITOR COIL, BUT IT WAS ALSO NOT ABLE TO BE WINDED AS INTENDED. THEREFORE, THE COMPETITOR COIL WAS REMOVED AS WELL. THE GUIDEWIRE (BRAND NOT SPECIFIED) WAS REINSERTED, AND THE PHYSICIAN CHANGED THE POSITION OF THE MICROCATHETER. HOWEVER, ANGIOGRAPHY CONFIRMED THAT BLEED

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 12211724 ↗
• MalfunctionNov 12, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE TIP OF THE BASILAR ARTERY (BA), A 4MM X 10CM GALAXY G3 COIL (GLY120410, L11153) WAS BEING USED AS THE FIRST FRAMING COIL BY A BALLOON ASSIST. IT WAS FRAMED AS INTENDED, AND ATTEMPTED TO BE DETACHED, BUT IT WAS NOT ABLE TO BE DETACHED, EVEN THOUGH THE DETACHMENT BUTTON WAS PRESSED FOUR TIMES. THE PHYSICIAN RE-SHEATHED AND CHANGED THE POSITION OF THE COIL BUT IT WAS NOT ABLE TO BE DETACHED. THE ENPOWER CONTROL CABLE (ECB00018200, 30396279), AND THE DETACHMENT CONTROL BOX (UNKNOWN PRODUCT/LOT NUMBER) WERE EACH REPLACED WITH ANOTHER DEVICE, BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER G3 COIL (4MM X 12CM), AND IT WAS DETACHED. THE COMPLAINT COIL WAS DETACHED OUTSIDE THE PATIENT AFTER BEING REMOVED. PICTURES WERE RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829488 ↗
• 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 (B)(4) 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 MICRUSFRAME 14 ¿ S11391) AND WERE THEREFORE NOT IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 9910945 ↗
• 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 9910938 ↗
• MalfunctionNov 11, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A SUBARACHNOID HEMORRHAGE (SAH), THE 4MM X 10CM GALAXY G3 COIL (GLY120410 / L11716) WAS CHOSEN AS A REPLACEMENT COIL FOR THE 5MM X 10CM GALAXY G3 COIL THAT HAD UNRAVELED AFTER THE DETACHABLE COIL DELIVERY SYSTEM (DCS) HAD BECOME STUCK IN THE MICROCATHETER. THE 4MM X 10CM GALAXY G3 COIL WAS USED WITH THE SL-10® MICROCATHETER (STRYKER), AND THIS COIL ALSO BECAME UNRAVELED. THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH THE TARGET COIL (STRYKER) THROUGH THE ECHELON MICROCATHETER (MEDTRONIC). THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9307107 ↗
• MalfunctionNov 11, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A SUBARACHNOID HEMORRHAGE (SAH), THE 4MM X 10CM GALAXY G3 COIL (GLY120410 / L11988) WAS CHOSEN AS A REPLACEMENT COIL FOR THE 4MM X 10CM GALAXY G3 COIL FROM LOT L11716 THAT HAD UNRAVELED AFTER IT WAS CHOSEN TO REPLACE THE 5MM X 10CM GALAXY G3 COIL (GLY120510 / L12892) WHEN THE DETACHABLE COIL DELIVERY SYSTEM (DCS) HAD BECOME STUCK IN THE MICROCATHETER. THIS 4MM X 10CM GALAXY G3 COIL ALSO BECAME UNRAVELED. THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH THE TARGET COIL (STRYKER) THROUGH THE ECHELON MICROCATHETER (MEDTRONIC). THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9307085 ↗
• MalfunctionNov 11, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM OF A SUBARACHNOID HEMORRHAGE (SAH), A 4MM X 10CM GALAXY G3 COIL (GLY120410, L13732) WAS NOT ABLE TO DETACH WHEN USING A AN ENPOWER CONTROL CABLE (ECB00018200, L16083). THE COMPLAINT CABLE WAS REPLACED WITH ANOTHER CABLE, BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE PHYSICIAN SUSPECTED THIS ISSUE MUST HAVE CAUSED BY THE COMPLAINT COIL BUT THE COMPLAINT CABLE IS ALSO ¿SUSPECTED¿ JUST IN CASE. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304438 ↗
• MalfunctionMar 4, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM, THE 4MM X 10CM GALAXY G3 (GLY120410/L13213) WAS SELECTED FOR USE AS A FRAMING COIL AND THE ENPOWER CONTROL CABLE (ECB000182-00/ L14493) WAS CONNECTED, BUT THE GREEN ¿SYSTEM READY¿ LIGHT ON THE ENPOWER DCB2 DETACHMENT CONTROL BOX DID NOT ILLUMINATE. THE CONTROL CABLE WAS REPLACED WITH ANOTHER CABLE, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE COIL WAS REPLACED, AND THE GREEN ¿SYSTEM READY¿ LIGHT ILLUMINATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8387261 ↗