GALAXY G3 GLM930080Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886704080343), received between Jul 16, 2018 and Jul 1, 2026 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K171862); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE GALAXY G3 MINI 3MM X 8CM COIL (GLM930080/1742522S) WAS IMPEDED IN THE PROXIMAL OF THE MICROCATHETER (NON-J&J) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED A SECOND GALAXY G3 MINI 3MM X 8CM COIL (GLM930080/1742522S), AND THE SECOND COIL HAD THE SAME ISSUE. THE PHYSICIAN ONLY RETRACTED THE SECOND COIL ALONE AND SWITCHED A THIRD COIL (NON-J&J) TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO PATIENT INJURY WAS REPORTED IN ASSOCIATION WITH THE EVENTS. THE PROCEDURE INVOLVED THE USE OF A MICROCATHETER FROM ANOTHER MANUFACTURER. OTHER DEVICES WERE SUCCESSFULLY USED BEFORE AND/OR AFTER THE REPORTED RESISTANCE. THE TARGET VESSEL WAS THE INTERNAL CAROTID ARTERY. RELEVANT ANATOMICAL DETAILS WERE NOT AVAILABLE. DURING THE PROCEDURE, RESISTANCE WAS NOTED AT THE MID-SECTION OF THE MICROCATHETER. CONTINUOUS FLUSHING WAS MAINTAINED, AND THE INTRODUCER TIP WAS PROPERLY CONNECTED TO THE MICROCATHETER HUB AND SECURED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS OF THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680042 ↗
• MalfunctionJul 1, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE GALAXY G3 MINI 3MM X 8CM COIL (GLM930080/1742522S) WAS IMPEDED IN THE PROXIMAL OF THE MICROCATHETER (NON-J&J) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED A SECOND GALAXY G3 MINI 3MM X 8CM COIL (GLM930080/1742522S), AND THE SECOND COIL HAD THE SAME ISSUE. THE PHYSICIAN ONLY RETRACTED THE SECOND COIL ALONE AND SWITCHED A THIRD COIL (NON-J&J) TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO PATIENT INJURY WAS REPORTED IN ASSOCIATION WITH THE EVENTS. THE PROCEDURE INVOLVED THE USE OF A MICROCATHETER FROM ANOTHER MANUFACTURER. OTHER DEVICES WERE SUCCESSFULLY USED BEFORE AND/OR AFTER THE REPORTED RESISTANCE. THE TARGET VESSEL WAS THE INTERNAL CAROTID ARTERY. RELEVANT ANATOMICAL DETAILS WERE NOT AVAILABLE. DURING THE PROCEDURE, RESISTANCE WAS NOTED AT THE MID-SECTION OF THE MICROCATHETER. CONTINUOUS FLUSHING WAS MAINTAINED, AND THE INTRODUCER TIP WAS PROPERLY CONNECTED TO THE MICROCATHETER HUB AND SECURED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS OF THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680014 ↗
• MalfunctionFeb 5, 2026Failure to Advance

  DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2025, THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 3.00MM X 8.00CM GALAXY G3 MINI COIL (GLM930080 / 1762503S) WAS IMPEDED IN THE MIDDLE SECTION OF THE CONCOMITANT MICROCATHETER AND COULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A SECOND COIL, ANOTHER 3.00MM X 8.00CM GALAXY G3 MINI COIL (GLM930080 / 1762503S). THE REPLACEMENT COIL ENCOUNTERED THE SAME ISSUE. THE PHYSICIAN RETRACTED THE SECOND COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURE AND COMPLETED THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THERE WERE NO REMARKABLE VESSEL CHARACTERISTICS. THE CONCOMITANT MICROCATHETER USED WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC); CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. PER THE INFORMATION, ANOTHER COIL DID GO THROUGH THE MICROCATHETER PRIOR TO THE REPORTED ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273666 ↗
• MalfunctionFeb 5, 2026Failure to Advance

  DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2025, THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 3.00MM X 8.00CM GALAXY G3 MINI COIL (GLM930080 / 1762503S) WAS IMPEDED IN THE MIDDLE SECTION OF THE CONCOMITANT MICROCATHETER AND COULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A SECOND COIL, ANOTHER 3.00MM X 8.00CM GALAXY G3 MINI COIL (GLM930080 / 1762503S). THE REPLACEMENT COIL ENCOUNTERED THE SAME ISSUE. THE PHYSICIAN RETRACTED THE SECOND COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURE AND COMPLETED THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 08-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THERE WERE NO REMARKABLE VESSEL CHARACTERISTICS. THE CONCOMITANT MICROCATHETER USED WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC); CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. PER THE INFORMATION, ANOTHER COIL DID GO THROUGH THE MICROCATHETER PRIOR TO THE REPORTED ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273653 ↗
• MalfunctionDec 12, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A MICROCATHETER (OTHER BRAND) WAS IN PLACE AND A GALAXY G3 MINI 3MM X 8CM COIL (GLM930080, 30927182) DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN INSPECTED INDICATOR LIGHT OF THE DETACHMENT CONTROL BOX (BCB) AND CONNECT CABLE AND OBSERVED ALL WERE UNDER GOOD CONDITION. THE DOCTOR PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH, THEN ONLY RETRACTED THE COIL AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-DEC-2024 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CONTROL CABLE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE COIL WAS NOT STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS DELAYED BY 5 MINUTES DUE TO THE EVENT. THERE WAS NO CLINICAL SIGNIFICANCE DUE TO THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914095 ↗
• InjuryJul 24, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A GALAXY G3 MINI 3MM X 8CM (GLM930080/ LOT # UNKNOWN) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, AN ANEURYSM PERFORATION OCCURRED. THE EVENT WAS REPORTED AS SUCH, ¿ANEURYSM PERFORATION WHILE USING SPECTRA COILS. UNSURE IF THE PERFORATION WAS CAUSE BY THE COILS OR THE MICROCATHETER. MICRO BALLOON CATHETER HAD BEEN USED TO STOP BLOCK FLOW AND COILS HAVE BEEN DEPLOYED TO ARREST BLOOD FLOW.¿ CLINICAL OUTCOME EXPERIENCED BY THE PATIENT WAS REPORTED AS SUCH, ¿BALLOON HAVE BEEN INFLATED FAST ENOUGH THAT NO BLUSH OR BLOOD POOL HAVE BEEN DETECTED AFTER PROCEDURE.¿ IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT¿S POST-PROCEDURE STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 12-JUL-2024. SUMMARY: PER THE INFORMATION RECEIVED, THE LOT NUMBER FOR THE IMPLANTED GALAXY G3 COIL WAS UNOBTAINABLE. THE TREATING PHYSICIAN DID NOT EXPRESS ANY COMMENT REGARDING POSSIBLE CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT. THE PATIENT¿S NEUROLOGICAL STATUS AFTER THE PERFORATION/RUPTURE IS UNKNOWN. REGARDING THE DEVICES IMPLANTED PRIOR TO THE EVENT, IT WAS COMMENTED, ¿FIRST DEVICES IMPLANTED IN

  Patient problems: Ruptured Aneurysm

  MAUDE report 19818983 ↗
• MalfunctionJan 10, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, 30896000) BECAME IMPEDED IN INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO A NON J&J MICROCATHETER (MC). THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE, A GALAXY G3 MINI 3MM X 8CM (GLM930080, 30865692) BUT THE SAME ISSUE OCCURRED. THE DOCTOR CHANGED THE THIRD COIL TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-NOV-2023 INDICATED THAT THE COILS WERE IMPEDED IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO THE MICROCATHETER. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484635 ↗
• 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 18070363 ↗
• MalfunctionAug 28, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR AN ANEURYSM AT THE LEFT POSTERIOR COMMUNICATING ARTERY, A GALAXY G3 MINI 3MM X 8CM COIL (GLM930080, 30824779) WAS UNABLE TO DETACH IN THE TARGET SITE. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED 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 17631704 ↗
• InjuryJun 14, 2023Deformation 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

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 60-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING (CURRENT SMOKER) UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION BRANCH ANEURYSM WITH A HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.4MM, DOME 10.5MM, MAXIMUM ANEURYSM DIAMETER 10.5MM, NECK SIZE 4.9MM, AND DOME-TO-NECK RATIO OF 2.1MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: AN 11MM X 18.9CM MICRUSFRAME 18 (MFR181118 / 30422246), A 5MM X 9.7CM MICRUSFRAME 10 (MFR100509 / 30537019), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / 30379819), A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30624675), AND A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30789543) VIA AN SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE PRINCIPAL INVESTIGATOR (PI), THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE; THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IMMEDIATE POST-PROCEDURE MODIFIED RAYM

  Patient problems: Aneurysm

  MAUDE report 17132000 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A (B)(6) MALE PATIENT WITH A HISTORY OF SMOKING (PREVIOUS) AND MANDIBULAR CANCER UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM ON (B)(6) 2019 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. INTEGRILIN/ASPIRIN WAS ADMINISTERED, AND NEUROFORM ATLAS STENT (STRYKER) WAS IMPLANTED. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2019 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE BIFURCATION ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 7.5MM, DOME 7.2MM, MAXIMUM ANEURYSM DIAMETER 7.5MM, NECK SIZE 5.9MM, AND DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.9MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS COILS: A 7MM X 13.9CM MICRUSFRAME 10 (MFR100713 / L13000), A 7MM X 21CM GALAXY G3 (GLY120721 / L13249), A 5MM X 10CM GALAXY G3 (GLY120510 / L12927), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / L13613), A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / L11233), AND A 2.00MM

  Patient problems: Thromboembolism

  MAUDE report 13101902 ↗
• InjuryJun 16, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF ANKYLOSING SPONDYLITIS UNDERWENT COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM ON (B)(6) 2020. THE HUNT & HESS GRADE SCORE WAS A 2 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. AT THE 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MRS SCORE WAS UNCHANGED. ON (B)(6) 2021, THE PATIENT UNDERWENT RETREATMENT OF THE TARGET ANEURYSM DUE TO THE RESIDUAL ANEURYSM. THREE COMPETITOR COILS WERE IMPLANTED WITH RAYMOND-ROY CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE ADVERSE EVENTS. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED A RUPTURED ANTERIOR COMMUNICATING ARTERY SACCULAR ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.2MM, DOME 5.7MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO 1.3MM. THE PARENT VESSEL DIAMETER WAS 3.0MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH

  Patient problems: Aneurysm

  MAUDE report 12013589 ↗
• InjuryMar 31, 2021Deformation 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 CORONARY ARTERY DISEASE (CAD), FOCAL NEUROLOGICAL DEFICITS, HEADACHES, PERIPHERAL VASCULAR DISEASE, HEADACHES, AND INTRACRANIAL ANEURYSM UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RECURRENT LEFT POSTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM ON (B)(6) 2020. THE TARGET ANEURYSM HAD BEEN PREVIOUSLY TREATED WITH UNSPECIFIED COILS ON (B)(6) 2019. 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2020 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIA: RESIDUAL ANEURYSM WITH CONTRAST WITHIN COIL INTERSTICES. MODIFIED RANKIN SCALE (MRS) SCORE WAS 1. RETREATMENT OF THE TARGET ANEURYSM WAS SUBSEQUENTLY PERFORMED DUE TO RESIDUAL ANEURYSM ON (B)(6) 2021. A 24CM COMPETITOR COIL WAS IMPLANTED WITH RAYMOND-ROY CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE ADVERSE EVENTS OR STUDY DEVICE DEFICIENCIES. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED AN UNRUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS: H

  Patient problems: Aneurysm

  MAUDE report 11594907 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A (B)(6) YEAR OLD FEMALE (SUBJECT 894-024) WITH A HISTORY OF BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT PCA ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.1MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 5.1MM, NECK SIZE 2.0MM, AND DOME-TO-NECK RATIO 1.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406/L16293), ONE 2MM X 2CM GALAXY G3 (GLY120202/L12097), ONE 3MM X 8CM GALAXY G3 MINI (GLM930080/L12616), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L11355), AND ONE 1MM X 1CM GALAXY G3 MINI (GLM910010/L14466) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 24.09% ANGIOSUITE PACKING DENSITY. ACCORDING TO THE CASE REPORT FORM (CRF), THERE WAS NO REPORTED MICROCATHETER KICKBACK. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH MODIFIED RAYMOND-ROY SCORE OF CLASS I: COMPLETE

  Patient problems: Aneurysm

  MAUDE report 11237011 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A (B)(6)-YEAR OLD FEMALE (SUBJECT 972-004) WITH A HISTORY OF FOCAL NEUROLOGICAL DEFICITS, HEADACHES, SMOKING (CURRENT), AND INTRACRANIAL ANEURYSMS (TOTAL OF 4) PRESENTED WITH A SUBARACHNOID HEMORRHAGE (HUNT & HESS GRADE 2) AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION OF A RUPTURED POSTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 3.3MM, DOME 5.7MM, MAXIMUM ANEURYSM DIAMETER 7.8MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO 1.3MM. THE PARENT VESSEL DIAMETER WAS 3.4MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L16657), ONE 3MM X 8CM GALAXY G3 MINI (GLM930080/L13408), TWO 3MM X 6CM GALAXY G3 MINI (GLM930060/L14489 & L12012), ONE 2MM X 6CM GALAXY G3 MINI (GLM920060/L16340), AND ONE 2MM X 4CM GALAXY G3 MINI (GLM920040/L15998) VIA AN ECHELON 10 (MEDTRONIC) MICROCATHETER. THE PATIENT EXPERIENCED A THROMBOEMBOLIC EVENT AT AN UNSPECIFIED TIME DURING THE PROCEDURE WHICH RESOLVED WITH MEDICATION. THE PATIENT WAS REPORTEDLY AS

  Patient problems: Stroke/CVA

  MAUDE report 10677687 ↗
• InjuryApr 17, 2019Positioning Failure; Premature Activation; Migration; Positioning Failure; Premature Activation; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A RECURRENT RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A 5.5 MM X 4 MM NECK REMNANT, A 4 MM X 10 CM GALAXY G3 XSFT WAS SELECTED, OPENED, AND CONNECTED TO AN ENPOWER CONTROL CABLE (ECB00018200 / L11342) TO CONDUCT A PRE-DEPLOYMENT ELECTRICAL CHECK, BUT THE GREEN ¿SYSTEM READY¿ LIGHT DID NOT ILLUMINATE ON THE DETACHMENT CONTROL BOX (DCB). THE ENPOWER CONTROL CABLE WAS REPLACED, AND THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED ON THE REPLACEMENT CONTROL CABLE. THE ¿SYSTEM READY¿ LIGHT ILLUMINATED ON THE DCB. THE 4 MM X 10 CM GALAXY G3 XSFT COIL WAS PREPPED, DELIVERED, AND THE COIL WAS DETACHED WITHOUT INCIDENT. NEXT, A 3MM X 8CM GALAXY G3 MINI COIL (GLM930080 / S15169) WAS SELECTED, IT PASSED THE PRE-DEPLOYMENT ELECTRICAL CHECK AND WAS PREPPED, DELIVERED THROUGH THE PROWLER SELECT MICROCATHETER WITHOUT ANY RESISTANCE WITH ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DIFFICULTY IN POSITIONING THE COIL IN THE ANEURYSM, BUT THE COIL FAILED TO DETACH AFTER THE FIRST DETACHMENT CYCLE HAD BEEN COMPLETED. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL FROM THE ANEURYSM BY

  Patient problems: No Code Available

  MAUDE report 8525104 ↗
• MalfunctionJul 16, 2018Stretched; Material Deformation; Stretched; Material Deformation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT TWO GALAXY G3 MINI COILS (GLM930080/L12111 & GLM930060/L12379) WERE USED DURING A PROCEDURE TO TREAT A RIGHT CAROTID 6MM PSEUDO ANEURYSM WHEN ONE DEVICE EXPERIENCED RESISTANCE IN THE MICROCATHETER AND THE DPU HERNIATED OUT OF THE SHEATH AND THE OTHER DEVICE EXPERIENCED RESISTANCE IN THE MICROCATHETER. VESSEL TORTUOSITY WAS LOW. THE ACCESS SET UP INCLUDED A SYNCHRO 14 GUIDE WIRE WITH A SOPHIA PLUS AND PROWLER SELECT LP ES .0165. A, GLM930080/L12111, GALAXY G3 MINI 3X8 WAS OPENED AND PREPPED CORRECTLY. DURING ADVANCEMENT INTO THE THUY BORST/MICROCATHETER, THE COIL ENCOUNTERED RESISTANCE. THE PHYSICIAN CONTINUED TO PUSH AND THE DPU HERNIATED OUT THE SIDE OF THE SHEATH. THE COIL, WHICH NEVER ENTERED THE PATIENT WAS THEN REMOVED AND SET ASIDE. A, GLM930060/L12379, GALAXY G3 MINI 3X6 WAS OPENED AND PREPPED CORRECTLY. DURING ADVANCEMENT INTO THE THUY BORST/MICROCATHETER, THE COIL ENCOUNTERED RESISTANCE. THE PHYSICIAN CONTINUED TO PUSH AND THE COIL THEN ADVANCED AND WAS DELIVERED AND DETACHED WITHOUT INCIDENT. THE COILING WAS COMPLETED AND THE PROCEDURE WAS ENDED WITHOUT INCIDENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691578 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171862. One submission often covers many models, so check the product and lot details in each record.

• Z-2280-2019 · May 16, 2019 · Terminated
  GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).