GALAXY G3 GLM930060Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886704080336), received between Jan 11, 2019 and Dec 1, 2025 — classified as 1 death, 9 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Stretched” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.00MM X 1.00CM GALAXY G3 MINI COIL (GLM910010 / 1352516S) WAS IMPEDED IN THE PROXIMAL END OF THE OF THE CONCOMITANT MICROCATHETER AND COULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A 3.00MM X 6.00CM GALAXY G3 MINI COIL (GLM930060 / 1612504S). THIS SECOND NEW COIL WAS IMPEDED IN THE DISTAL END OF THE MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE SECOND COIL AND REPLACED IT WITH A THIRD COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 05-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING AN ANEURYSM ON THE C7 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) WITH NORMAL VESSELS. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER, WHICH WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). THE DEVICES DID NOT APPEAR DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE TIP OF THE INTRODUCERS WAS FIRMLY INSTALLED ON THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689120 ↗
• MalfunctionJan 29, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A NON-J&J MICROCATHETER (MC) WAS IN PLACE AND A GALAXY G3 MINI 2.5MM X 5.5CM COIL (GLM925055, 30824771) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR INSPECTED INDICATOR LIGHT OF THE DETACHMENT CONTROL BOX (DCB) 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 THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A SECOND NEW COIL TO FILL THE ANEURYSM AND BE DETACHED SUCCESSFULLY. LATER THE THIRD COIL, A GALAXY G3 MINI 3MM X 6CM (GLM930060, 30889366) HAD THE SAME ISSUE WHEN IT WAS TO BE DETACHED, THE DOCTOR ONLY RETRACTED THE THIRD COIL ALONE AND SWITCHED TO A FOURTH NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-JAN-2025 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CONTROL CABLE WERE SUCCESSFULLY WITH SUBSEQUENT COILS. THE COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264573 ↗
• MalfunctionJan 23, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 3MM X 6CM COIL (GLM930060, 30824775) WAS FILLED IN ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 19-JAN-2024 INDICATED THAT THE SAME DCB AND CONTROL CABLE WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. NO ADDITIONAL INTERVENTION WAS NEEDED. THERE WAS NO COIL DAMAGE. THERE WERE NO PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18561963 ↗
• MalfunctionDec 28, 2023Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM VIA FEMORAL ACCESS. FEMORAL ARTERY PUNCTURE WAS DONE TO INSERT 8F OPTIMO FLEX GUIDING CATHETER (TOKAI MEDICAL) TO THE INTERNAL CAROTID ARTERY (ICA), THEN DIRECT ACCESS VIA A GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL) WAS ADVANCED ALONG THE CATHETER TO THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). AN SL-10® MICROCATHETER (STRYKER) WAS ADVANCED TO THE A2 SEGMENT AND AN ECHELON¿ 14 MICROCATHETER (MEDTRONIC) WAS INSERTED INTO THE ANEURYSM VIA THE JAILING TECHNIQUE. THE FIRST COIL, A 3.00MM X 6.00CM GALAXY G3 MINI (GLM930060 / LOT# UNKNOWN) WAS PLACED VIA THE ECHELON 14 MICROCATHETER; IT WAS REPORTED THAT THIS COIL PROTRUDED INTO THE PARENT VESSEL, SO A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS DEPLOYED DURING WINDING VIA THE SL-10® MICROCATHETER. THE FIRST COIL WAS DETACHED. THE SECOND COIL, A 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 30937885) WAS INSERTED INTO THE ECHELON 14 MICROCATHETER, BUT STRONG RESISTANCE WAS FELT INSIDE THE INTRODUCER SHEATH AND IT COULD NOT BE ADVANCED; THE COIL WAS RETRIEVED. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414008 ↗
• MalfunctionSep 19, 2023Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  AS REPORTED BY THE FIELD, AFTER SEVERAL TARGET COILS (STRIKER) WERE IMPLANTED, A GALAXY G3 MINI 3MM X 6CM MINI COIL (GLM930060, 30820672) WAS DELIVERED TO THE LESION. BEFORE INSERTION, AN ELECTRICAL CHECK WAS DONE TO CONFIRM THE COIL COULD BE USED AS NORMAL. AFTER THE COIL HAD BEEN INSERTED, THE DETACH CABLE WAS CONNECTED, BUT THE DETACH LIGHT DID NOT ILLUMINATE. THE GALAXY G3 MINI COIL WAS RECONNECTED, BUT THE ISSUE CONTINUED, SO THE COIL WAS RETRIEVED. REPLACED WITH COMPETITOR'S COIL AND THE PROCEDURE WAS COMPLETED. AFTER RETRIEVAL OF THE GALAXY G3 MINI COIL FROM THE PATIENT¿S BODY, THE PHYSICIAN TRIED TO PULL IT OUT FROM THE SHEATH IN A CLEAN AREA, BUT THE COIL DID NOT COME OUT FROM THE SHEATH AND FELT RESISTANCE, SO DECIDED THAT THE PRODUCT COULD NOT BE USED AGAIN. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773023 ↗
• InjuryJan 9, 2023Entrapment of Device; Material Separation; Stretched; Positioning Problem; Entrapment of Device; Material Separation; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR STENT-ASSISTED COIL EMBOLIZATION PROCEDURE THAT WAS TARGETING AN INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) ANEURYSM, THE COIL EMBOLIZATION WAS PERFORMED BY THE JAILING TECHNIQUE USING A 4MM X 21MM NEUROFORM ATLAS® STENT (STRYKER). PER THE EVENT DESCRIPTION, FIRST, AN EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER) WAS DELIVERED TO THE MIDDLE CEREBRAL ARTERY (MCA) FOR THE STENT, AND THEN AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) FOR COIL EMBOLIZATION WAS PLACED IN THE ANEURYSM. A 9MM TARGET XL COIL (STRYKER) WAS USED BUT IT WAS UNABLE TO BE FIT AS INTENDED. IT WAS REPLACED WITH AN 8MM COIL (UNSPECIFIED BRAND). THE STENT WAS DEPLOYED WITH THE FRAMING COIL ROLLED ABOUT HALF. THE FRAMING COIL WAS UNDERSIZED AFTER ALL AND WAS UNABLE TO BE FRAMED IN THE DIRECTION AT 1:00. THE EXCELSIOR® XT-17¿ MICROCATHETER ¿WAS TRANS-CELLED,¿ FROM WHICH AN ADDITIONAL COIL, A 4MM TARGET ULTRA COIL (STRYKER) WAS FRAMED. IT WAS THEN REPORTED THAT AFTER THAT, TWO COILS, (I-ED INFINI 3×5 OF 20 CM) AND ONE COIL (15 CM) WERE DELIVERED VIA THE EXCELSIOR® SL-10® MICROCATHETER. TWO (2) 3MM TARGET COILS WERE DELIVERED VIA THE EXCELSIOR® XT-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16127997 ↗
• MalfunctionJan 6, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR SUBARACHNOID HEMORRHAGE (SAH), A GALAXY G3 MINI 3MM X 6CM COIL (GLM930060, 30641972) WAS ATTEMPTED TO BE INSERTED BUT THE SHEATH GOT DAMAGED, AND DELIVERING WAS IMPOSSIBLE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. A CONTINUOUS FLUSH WAS DONE. A PHENOM MICROCATHETER WAS USED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO RESISTANCE REPORTED. NO NECK REMODELING WAS UTILIZED. THE MICROCOIL WAS NOT POSITIONED AT A RELATIVELY SHARP ANGLE TO THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112402 ↗
• MalfunctionDec 14, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 3.00MM X 6.00CM GALAXY G3 MINI (GLM930060 / 30675515) WAS PLACED IN THE TARGET POSITION. THE PHYSICIAN PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL, BUT THE FAULT LIGHT ILLUMINATED AND THE COIL COULD NOT BE DETACHED. A NEW DETACHMENT BOX AND CABLE WERE USED BUT THE COMPLAINT COIL STILL FAILED TO DETACH. ANOTHER COIL, COMPETITOR BRAND) WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY. ON 08-DEC-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET OF THE PROCEDURE WAS THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE COIL DID NOT BECOME SEPARATED NOR BROKEN DURING THE REMOVAL. THE BRAND OF THE MICROCATHETER USED WAS NOT KNOWN, BUT THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. UPON PRESSING THE POWER BUTTON, ONLY THE RED SYSTEM FAULT LIGHT ILLUMINATED. THE GREEN SYSTEM READY LIGHT DID ILLUMINATE BUT DURING THE DETACHMENT CYCL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982795 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 68-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE SACCULAR ANEURYSM AT THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 5.5MM, DOME 8.4MM, MAXIMUM ANEURYSM DIAMETER 8.4MM, NECK SIZE 4.3MM, AND THE DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.8MM. COIL EMBOLIZATION WAS PERFORMED WITH A TOTAL OF TEN (10) COILS. THE FOLLOWING SIX (6) CERENOVUS COILS WERE IMPLANTED: ONE 7MM X 21CM GALAXY G3 (GLY120721 / L15699), ONE 6MM X 15CM GALAXY G3 (GLY120615 / L13589), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L13315), ONE 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / L13521), ONE 3MM X 6CM GALAXY G3 MINI (GLM930060 / L13936) AND ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / L13672). IN ADDITION, FOUR (4) 2MM X 3CM TARGET® 360 NANO¿ COIL (STRYKER) WERE ALSO IMPLANTED. ALL COILS WERE DELIVERED VIA THE HEADWAY® 17 MICROCATHETER (MICROVENTION). A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED. THERE WAS NO INTRA-OPERATIVE ANEURYSM RUPTURE

  Patient problems: Ischemia Stroke

  MAUDE report 15547408 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED AN ADVERSE EVENT THAT OCCURRED DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. A HYDRO COIL (COMPETITOR PRODUCT) WAS IMPLANTED AS THE FIRST COIL. TWO (2) 3.00MM X 6.00CM GALAXY G3 MINI COILS (GLM930060 / LOT# UNKNOWN) WERE USED. IT WAS REPORTED THAT ¿THE COMPLAINT COILS MOVED AS IF RUPTURED THE ANEURYSM, BUT THE COMPLAINT COILS WERE IMPLANTED AS SCHEDULED.¿ A MINI COIL (UNSPECIFIED BRAND) WAS INSERTED AS THE THIRD COIL, BUT IT WAS CONFIRMED THAT THE COILS PIERCED THE ANEURYSM. AS A RESULT, COIL EMBOLIZATION WAS COMPLETED WITH OTHER COMPETITOR COILS. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS MAINTAINED. THE REPORTED EVENT WAS CONSIDERED NON-SERIOUS (MODERATE / MINIMAL). NO OTHER DETAILS WERE PROVIDED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 15227797 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED AN ADVERSE EVENT THAT OCCURRED DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. A HYDRO COIL (COMPETITOR PRODUCT) WAS IMPLANTED AS THE FIRST COIL. TWO (2) 3.00MM X 6.00CM GALAXY G3 MINI COILS (GLM930060 / LOT# UNKNOWN) WERE USED. IT WAS REPORTED THAT ¿THE COMPLAINT COILS MOVED AS IF RUPTURED THE ANEURYSM, BUT THE COMPLAINT COILS WERE IMPLANTED AS SCHEDULED.¿ A MINI COIL (UNSPECIFIED BRAND) WAS INSERTED AS THE THIRD COIL, BUT IT WAS CONFIRMED THAT THE COILS PIERCED THE ANEURYSM. AS A RESULT, COIL EMBOLIZATION WAS COMPLETED WITH OTHER COMPETITOR COILS. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS MAINTAINED. THE REPORTED EVENT WAS CONSIDERED NON-SERIOUS (MODERATE / MINIMAL). NO OTHER DETAILS WERE PROVIDED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 15227718 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 50-YEAR-OLD FEMALE ((B)(6)) WITH A MEDICAL HISTORY OF CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF A RIGHT UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE ANTERIOR CIRCULATION, MIDDLE CEREBRAL ARTERY BIFURCATION ON (B)(6) 2020. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED ON (B)(6) 2020, THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 3.9MM, DOME 2.7MM, MAXIMUM ANEURYSM DIAMETER 5MM, NECK SIZE 2.2MM, AND DOME-TO-NECK RATIO 1.2MM. THE PARENT VESSEL DIAMETER WAS 3MM. THE FOLLOWING COILS WERE IMPLANTED VIA AN SL-10 (STRYKER) MICROCATHETER: ONE 4MM X 6MM CASHMERE 14 (MICRUS), ONE 3MM X 6MM GALAXY G3 MINI (GLM930060/K10497), ONE 2MM X 3CM GALAXY G3 MINI (GLM920030/30386750) AND ONE 2MM X 3CM GALAXY G3 MINI (GLM920030/L11009). THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE THROMBOEMBOLIC EVENTS. PACKING DENSITY WITHOUT G3 MINI COILS (USING ANGIOSUITE) WAS 20% AND AT THE CONCLUSION OF THE PROCEDURE (USING ANGIOSUITE) WAS 22%. IN THE OPINION OF THE INVESTIGATOR, THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH NO DEVICE-RELATED SERIO

  Patient problems: Aneurysm

  MAUDE report 14427641 ↗
• MalfunctionMar 11, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3.00MM X 6.00CM GALAXY G3 MINI (GLM930060 / 30429060) WAS THE SECOND COIL USED; IT COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COMPLAINT COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, IT WAS OBSERVED THAT THE COIL WAS STRETCHED. THE PHYSICIAN USED ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737303 ↗
• MalfunctionNov 3, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3.00MM X 6.00CM GALAXY G3 MINI COIL (GLM930060 / K10504) WAS THE SECOND COIL USED; THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. THE EMBOLIC COIL WAS OBSERVED TO BE STRETCHED DURING THE INSPECTION AFTER REMOVAL. THE PHYSICIAN USED ANOTHER ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE / COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746792 ↗
• InjuryAug 23, 2021Stretched; Premature Separation; Stretched; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT A (B)(6) FEMALE UNDERWENT PULSERIDER-ASSISTED COIL EMBOLIZATION OF A RECANALIZED LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM ON (B)(6) 2021. DURING THE PROCEDURE, A 3MM X 6CM GALAXY G3 MINI (GLM930060/30412537) WAS SELECTED FOR USE AS THE TENTH FINISHING COIL, BUT THE MICROCOIL BECAME UNRAVELED AND PREMATURELY DETACHED AND WAS PLACED OUTSIDE OF THE ANEURYSM AT THE M1. A NEUROFORM ATLAS (STRYKER) STENT WAS SUBSEQUENTLY IMPLANTED BETWEEN THE M2 AND THE INTERNAL CAROTID ARTERY (ICA) TO SECURE THE PREMATURELY DETACHED MICROCOIL TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. THE PATIENT WILL BE MONITORED ON PROLONGED DUAL ANTIPLATELET THERAPY (DAPT). THE PATIENT HAS BEEN HOSPITALIZED. THE PHYSICIAN COMMENTED THAT THE EVENT WAS NOT SERIOUS BECAUSE THE PREMATURELY DETACHED COIL WAS PLACED, AND THERE WERE NO OTHER ISSUES ENCOUNTERED. HE BELIEVES ¿IT WAS TOO BAD¿ THE COMPLAINT COIL REMAINED IN THE PATIENT. THE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) WAS IMPLANTED AT THE LEFT MCA WITHOUT INCIDENT. COIL EMBOLIZATION WAS THEN INITIATED BETWEEN THE RECANALIZATION SPACE AND PULSERIDER LEAFLET. A TOTAL OF NINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353479 ↗
• MalfunctionMay 18, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA) COIL EMBOLIZATION PROCEDURE, AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A 4F SHEATH. AN ANGIO CATHETER WAS ADVANCED TOWARD THE LEFT INTERNAL THORACIC ARTERY. A CONCOMITANT PROWLER SELECT LPES MICROCATHETER WAS INSERTED INTO THE PATIENT AND ADVANCED TOWARD A SHUNT. COIL EMBOLIZATION BEGAN. AFTER SEVERAL COILS WERE IMPLANTED, THE 3.00MM X 6.00CM GALAXY G3 MINI COIL (GLM930060 / 30409529) WAS USED. THE PHYSICIAN PRESSED THE SHEATH INTRODUCER AGAINST THE HUB OF THE MICROCATHETER AND INSERTED THE DELIVERY WIRE BUT THE COIL WAS NOT ABLE TO BE ADVANCED. THE SYSTEM WAS FLUSHED AND THE PHYSICIAN MADE ANOTHER ATTEMPT TO ADVANCE THE COIL BUT THE SAME ISSUE CONTINUED. THE DELIVERY WIRE WAS STUCK AT THE SAME PART. THE COIL WAS REPLACED AND THE PROCEDURE CONTINUED. SEVERAL COILS WERE IMPLANTED AND ANOTHER COIL, A 2.00MM X 6.00CM GALAXY G3 MINI COIL (GLM920060 / 30386752) WAS USED BUT THE SAME ISSUE WAS ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. A REPLACEMENT COIL WAS USED WITHOUT ISSUE AND THE PROCEDURE CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11844438 ↗
• MalfunctionJan 26, 2021Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A CEREBRAL COIL EMBOLIZATION OF A UNRUPTURED ANEURYSM AT THE VERTEBRAL ARTERY, A 3MM X 6CM GALAXY G3 MINI COIL (GLM930060, 30409529) WAS ATTEMPTED TO BE INSERTED INTO AN SL10 MICROCATHETER, BUT IT GOT STUCK ON THE INTRODUCER SHEATH AND THE COIL WAS NOT ABLE TO COME OUT. THE PHYSICIAN PUSHED SEVERAL TIMES, BUT A PART OF THE SHEATH GOT TORN AND THE COIL PART WAS EXPOSED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DAMAGE TO THE MICROCATHETER (MC) DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE DEVICE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229264 ↗
• MalfunctionDec 14, 2020Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN FELT STRONG RESISTANCE DURING THE ADVANCEMENT OF A 3MM X 6CM GALAXY G3 MINI COIL (GLM930060, 30379818) THROUGH THE SHEATH. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002646 ↗
• InjuryDec 5, 2020Migration; Premature Separation; Migration; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, A 3.00MM X 6.00CM (B)(4) G3 MINI COIL ((B)(4)) BECAME PREMATURELY DETACHED WHILE IT WAS BEING IMPLANTED. IT WAS IMPOSSIBLE TO REMOVE, AND THEREFORE, IT WAS LEFT IMPLANTED AS IS. IT WAS THEN REPORTED THAT THE COIL SLIGHTLY PROTRUDED OUT TOWARD THE PARENT BLOOD VESSEL. AS A RESULT, A COMPETITOR STENT, A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED TO SECURE THE PROTRUDING COIL TO THE VESSEL WALL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 19 NOVEMBER 2020 INDICATED THAT THE 3.00MM X 6.00CM (B)(4) G3 MINI COIL WAS USED IN THE MIDDLE OF THE PROCEDURE. THE EMBOLIC COIL UNINTENDEDLY DETACHED AFTER BEING WINDED THREE TIMES. IT WAS REPORTED THAT THE INSIDE OF THE ANEURYSM WAS NOT YET DENSELY PACKED, AND THE PHYSICIAN DID NOT FEEL ANY COIL ENTANGLEMENT OR RESISTANCE. THE PHYSICIAN NEITHER CONNECTED / DISCONNECTED THE CONTROL CABLE, NOR PRESSED THE DETACHMENT BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950456 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR OLD FEMALE (SUBJECT (B)(6) 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 ASYMPT

  Patient problems: Stroke/CVA

  MAUDE report 10677707 ↗
• 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 (B)(6)) 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 ASY

  Patient problems: Stroke/CVA

  MAUDE report 10677700 ↗
• MalfunctionAug 13, 2020Fracture; Retraction Problem; Stretched; Premature Separation; Fracture; Retraction Problem; Stretched; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM THAT IS 3.5MM IN WIDTH AND 5.5MM IN LENGTH ON THE POSTERIOR COMMUNICATING ARTERY (PCOM) WITH MILD VESSEL TORTUOSITY, THE FIRST TWO LOOPS OF THE 3.00MM X 6.00CM GALAXY G3 MINI COIL (GLM930060 / L16397) WERE PLACED INTO THE ANEURYSM AND THE COIL WAS ADVANCED, THE NEXT COIL LOOP WOULD NOT FORM/BREAK AND IT PUSHED THE CONCOMITANT SL-10® 45° TIP MICROCATHETER (STRYKER) BACK. THE PHYSICIAN FELT THAT THE COIL WAS DEFECTIVE, AND HE ATTEMPTED TO REMOVE THE COIL AND IT BECAME HUNG UP WITHIN THE MICROCATHETER. PART OF THE COIL WAS STILL IN THE ANEURYSM; THE PHYSICIAN TRIED TO ADVANCE THE COIL AND RETRIEVE IT AGAIN AND THE COIL BECAME PREMATURELY DETACHED FROM THE DELIVERY WIRE AT THE DETACHMENT ZONE. THE PHYSICIAN THEN REMOVED THE MICROCATHETER WITH THE DETACHED COIL. A NEW MICROCATHETER AND COIL WERE USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404591 ↗
• MalfunctionJul 14, 2020Stretched; Detachment of Device or Device Component; Material Twisted/Bent; Stretched; Detachment of Device or Device Component; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN FELT STRONG RESISTANCE WHILE ADVANCING THE FIRST COIL, A 3MM X 6CM GALAXY G3 MINI (GLM930060, L16397) THROUGH THE HUB OF AN EXCELSIOR MICROCATHETER (MC). THERE WAS NO PATIENT INJURY REPORTED. THE COIL DID NOT SUCCESSFULLY DEPLOY IN THE ANEURYSM. THE DEVICE WAS REMOVED THROUGH THE MICROCATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE DEVICE INVESTIGATION, THE EMBOLIC COIL WAS MECHANICALLY DETACHED FROM THE DEVICE, STRETCHED AND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10270819 ↗
• MalfunctionJul 2, 2020Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, WHEN USING A 3MM X 6CM GALAXY G3 MINI COIL (GLM930060, L14656) AS THE FINISHING COIL. THE COIL DELIVERY SYSTEM WAS INSERTED INTO THE HUB OF AN EXCELSIOR XT-17,STRYKER MICROCATHETER (MC). HOWEVER, THE DELIVERY WIRE WAS EXPOSED FROM A SPLIT PART OF THE SHEATH. IT SEEMED NOT TO DELIVER THE COMPLAINT COIL INTO THE MICROCATHETER. THE PROCEDURE WAS COMPLETED. IT SEEMS THAT THE CRACK OF THE INTRODUCER MIGHT HAVE BEEN WIDER THAN USUAL. PERHAPS THE JUNCTION PART OF THE COIL POPPED OUT AND TENSION WAS NOT ABLE TO BE APPLIED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE DEVICE INVESTIGATION, THE EMBOLIC COIL WAS FOUND SLIGHTLY STRETCHED AND KINKED INSIDE THE INTRODUCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224352 ↗
• MalfunctionFeb 26, 2020Stretched; Material Twisted/Bent; Premature Separation; Stretched; Material Twisted/Bent; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 3.00MM X 6.00CM GALAXY G3 MINI COIL (GLM930060 / L14479) WAS USED BUT THE COIL WAS NOT ABLE TO EXIT FROM THE INTRODUCER SHEATH. THE COIL WAS REPLACED. 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 MECHANICALLY DETACHED IN STRETCHED AND KINKED CONDITION INSIDE THE INTRODUCER TUBE. BASED ON THE PRODUCT ANALYSIS 2/24/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753702 ↗

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).