GALAXY G3 GLM925045Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886704080275), received between Dec 13, 2018 and Dec 11, 2024 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 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 2.5MM X 4.5CM COIL (GLM925045, 30865683) WAS 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 (DBC) AND CONNECTED 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 09-DEC-2024 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CONTROL CABLE WERE SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL DID NOT STRETCH OR WAS DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WAS A 5 MINUTES PROCEDURAL DELAY WITH NO CLINICAL SIGNIFICANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907879 ↗
• InjuryMar 15, 2024Migration; Migration

  THE EVENT WAS REPORTED VIA THE STERLING STUDY. A 79-YEAR-OLD FEMALE PATIENT UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE ANTERIOR COMMUNICATING ARTERY (ACA) BIFURCATION ANEURYSM ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 4.6MM, DOME 4.9MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 6.1MM, AND DOME-TO-NECK RATIO OF 0.8MM. THE PARENT VESSEL DIAMETER WAS 2.8MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. ON 04-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION AND VIA EMAIL AND PHONE DISCUSSION WITH THE STERLING CLINICAL STUDY TEAM, THE FOLLOWING INFORMATION WAS RECEIVED: THE PLACEMENT OF THE PULSERIDER DEVICE FAILED AND THE STRATEGY WAS CHANGED TO STENT-ASSISTED COIL EMBOLIZATION. AFTER PLACING A 3MM X 15MM NEUROFORM ATLAS® STENT (STRYKER) FROM THE LEFT A2 SEGMENT OF THE ANTERIOR COMMUNICATING ARTERY, INTRACRANIAL COIL EMBOLIZATION WAS STARTED. THE 2.50MM X 4.50CM GALAXY G3 MINI (GLM925045 / 30393182) WAS PLACED AS THE FIRST COIL. THEN THE SECOND COIL, 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / 30392736) WAS PLACED, BUT IT PUSHED THE FIRST COIL AND ONE LOOP OF THE FIRST COIL BECAME PROTRUDED OUTSIDE OF THE ANEURYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918290 ↗
• MalfunctionDec 12, 2023Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THERE WAS NO DETACHMENT OF THE COMPLAINT COIL, A 2.50MM X 4.50CM GALAXY G3 MINI (GLM925045 / 31035631) ON THE FIRST ATTEMPT. THE COIL BECAME PREMATURELY DETACHED IN THE MICROCATHETER AND HAD TO BE PUSHED INTO THE ANEURYSM SAC. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311259 ↗
• InjuryAug 2, 2022Material Separation; Migration; Premature Separation; Material Separation; Migration; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / K10503), A PREMATURE DETACHMENT OCCURRED LEAVING THE EMBOLIC COIL IN THE ACOMM ALL THE WAY INTO THE CAVERNOUS INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL WITH A SNARE, HOWEVER, AFTER CAPTURE, THE COIL BECAME SEPARATED INTO TWO (2) PARTS. THE DISTAL SEGMENT OF THE COIL IS IN THE ANEURYSM WITH THE TAIL TO THE BIFURCATION JUNCTION WITH NO PULSATILE MOVEMENT SEEN. THE PROXIMAL SEGMENT OF THE COIL WAS RETRIEVED AND REMOVED. A CLOT THEN APPEARED IN THE A1 SEGMENT. IT WAS RESOLVED WITH THE ADMINISTRATION OF AGRASTAT. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE DOSAGE OF AGRASTAT ADMINISTERED IS NOT KNOWN. IT WAS ALSO NOT KNOWN IF THE CLOT WAS A RESULT OF THE DISTAL SEGMENT OF THE COIL TAIL PROTRUDING INTO THE BIFURCATION JUNCTION. THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED EVENT. THE DOSAGES OF PRE- AND POST-PROCEDURE ANTIPLATELET MEDICAT

  Patient problems: Thromboembolism

  MAUDE report 15153356 ↗
• MalfunctionMar 7, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING THE RESHEATHING OF A 2.5MM X 4.5CM GALAXY G3 MINI COIL ( GLM925045, 30383054) THE COIL THE INTRODUCER FAILED TO BE RE-ZIPPED. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS OBSERVED STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685018 ↗
• MalfunctionJan 3, 2022Material Rupture; Stretched; Difficult to Advance; Material Rupture; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION WITH THE TARGET ANEURYSM AT THE BASILAR ARTERY, WHEN THE COMPLAINT COIL A 2.50MM X 4.50CM GALAXY G3 MINI (GLM925045 / L15548) WAS BEING INSERTED INTO THE CONCOMITANT SL-10® MICROCATHETER (STRYKER), THERE WAS A LITTLE RESISTANCE FELT BETWEEN THE COIL AND THE MICROCATHETER. THE PHYSICIAN PROCEEDED AS HE/SHE WAS THINKING IT WOULD BE FINE. HOWEVER, THE COMPLAINT COIL CAME OUT OF THE PEEL AWAY / INTRODUCER SHEATH. THE DELIVERY WIRE WAS PULLED BACK IN ATTEMPT TO RESTORE THE INTRODUCER SHEATH, BUT IT WAS NOT SUCCESSFUL AND THE COMPLAINT COIL UNRAVELED. THE COMPLAINT COIL BECAME UNSTABLE AND WAS REMOVED. A NEW COIL WAS IMPLANTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETE WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142894 ↗
• MalfunctionDec 16, 2021Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / 30383054) BECAME KINKED IN THE PROWLER SELECT LPES MICROCATHETER. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020031 ↗
• MalfunctionSep 23, 2021Entrapment of Device; Entrapment of Device

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), FOUR UNSPECIFIED COILS WERE IMPLANTED AND THE COMPLAINT COIL, A GALAXY G3 MINI 2.5MM X 4.5CM (GLM925045, LOT UNKNOWN) WAS USED. THIS COIL WAS INSERTED AND DETACHED. THE PHYSICIAN REMOVED THE DELIVERY WIRE BUT THE COIL PART WAS ATTACHED TO THE DELIVERY WIRE. AFTER THAT, THE DELIVERY WIRE WAS PUSHED FURTHER BUT THE COIL PART WAS DETACHED. AN UNSPECIFIED COIL WAS ADDED, AND THE PROCEDURE WAS COMPLETED. IT WAS UNCLEAR IF A CONTINUOUS FLUSH WAS DONE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518636 ↗
• MalfunctionSep 1, 2021Break; Positioning Failure; Break; Positioning Failure

  AS REPORTED BY THE FIELD, DURING A RECANALIZATION AT THE INTERNAL CAROTID ARTERY ANEURYSM, A 2MM X 6CM GALAXY G3 MINI COIL (GLM920060, L13998) WAS USED BUT IT WAS RE-SHEATHED BECAUSE IT CAME OUT FROM THE ANEURYSM. IT WAS REPLACED WITH ANOTHER COMPLAINT COIL, A 2.5MM X 4.5CM GALAXY G3 MINI COIL (GLM925045, L13812) BUT IT ALSO CAME OUT FROM THE ANEURYSM. THE PHYSICIAN NOTICED THAT THE CONCOMITANT MICROCATHETER WAS OUT OF POSITION. THEREFORE, THE COMPLAINT COIL WAS RE-SHEATHED ONCE TO MOVE THE MICROCATHETER AT THE PROPER POSITION. THE POSITION OF THE MICROCATHETER WAS MODIFIED. THE PHYSICIAN TRIED TO USE THE COMPLAINT COILS BUT THE SHEATHES WERE DAMAGED. THEY WERE REPLACED WITH OTHER COILS AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406235 ↗
• MalfunctionMar 31, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, WHEN THE DOCTOR TRIED TO DETACH A 2.5MM X 4.5CM GALAXY G3 MINI COIL (GLM925045, 30396261), THE BEEP WAS NORMAL, BUT THE COIL WAS NOT DETACHED. THE DOCTOR USED ANOTHER SAME LIKE PRODUCT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A PHOTO OF THE DEVICE WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594753 ↗
• MalfunctionMar 25, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / 30396261) WAS NOT ABLE TO BE ADVANCED IN THE CONCOMITANT MICROCATHETER. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDING. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 25 MARCH 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572916 ↗
• MalfunctionFeb 8, 2021Material Rupture; Stretched; Failure to Advance; Material Rupture; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DURING THE COIL EMBOLIZATION OF AN ANEURYSM, THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / 30392252) WAS CHOSEN AS THE SECOND COIL, BUT THE COIL BECAME STUCK ON THE INTRODUCER SHEATH. THE SHAFT CAME OUT FROM THE INTRODUCER SHEATH AND THE COIL INTRODUCER BECAME DAMAGED. THE COMPLAINT COIL WAS BEING USED WITH THE SL-10® MICROCATHETER (STRYKER); CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. FORCE WAS NOT APPLIED TO THE DEVICE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE. PRELIMINARY PHOTO IMAGES OF THE COMPLAINT DEVICE WERE CAPTURED BY THE J&J (B)(6)AFFILIATES ON (B)(6) 2021 AND INCLUDED IN THE COMPLAINT FILE ON (B)(6) 2021. BASED ON THE REVIEW OF THE PHOTOS BY THE PRODUCT ANALYSIS LAB COMPLETED ON 08 FEBRUARY 2021, THE 1.00MM X 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / 30392252) IS OBSERVED TO BE IN STRETCHED CONDITION. BASED ON THE REVIEW OF THE PHOTOS, THE EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298609 ↗
• MalfunctionDec 31, 2020Entrapment of Device; Activation Problem; Entrapment of Device; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / 30383054) PARTIALLY DEPLOYED OUT THE DISTAL END OF THE HEADWAY® 17 MICROCATHETER (MICROVENTION-TERUMO), BECAME STUCK AND THEN ENTANGLED WITH THE PREVIOUSLY PLACE 3.5MM X 6.6CM MICRUSFRAME 10 COIL (MFR100356 / LOT# UNKNOWN) AND BECAME STRETCHED. IT WAS REPORTED THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. MOST OF THE RESISTANCE WAS FELT AT THE TIP OF THE MICROCATHETER. THERE WAS NO KINK OR DAMAGE ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE ISSUE REPORTED. THE MICROCATHETER WAS PROPERLY FLUSHED AND DELIVERED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORT OF ANY BLOOD FLOW RESTRICTION OR REDUCTION AS A RESULT OF THE ISSUE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING STRYKER COILS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102360 ↗
• MalfunctionDec 29, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH THE TARGET VESSEL BEING THE INTERNAL CAROTID ARTERY (ICA), THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / L15582) WAS INSERTED INTO THE TARGET LESION THEN AN ATTEMPT TO DETACH THE COIL WAS MADE WITH THE ENPOWER CONTROL CABLE (ECB00018200 / K10545) PER THE INSTRUCTIONS FOR USE (IFU). THE GREEN SYSTEM READY LIGHT WAS ILLUMINATED, AND THE AUDIBLE BEEP SIGNAL WAS HEARD. HOWEVER, THE COMPLAINT COIL DID NOT DETACH. THE ENPOWER CONTROL CABLE WAS REPLACED WITH ANOTHER CABLE, BUT THE SAME ISSUE OCCURRED. THE COMPLAINT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER COIL; THE REPLACEMENT COIL WAS DETACHED WITH THE REPLACEMENT CABLE WITHOUT ANY ISSUE. THE REPORTED EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11090068 ↗
• InjuryAug 11, 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 HEADACHES, MIGRAINES, AND ANXIETY PRESENTED WITH A SUBARACHNOID HEMORRHAGE (HUNT & HESS GRADE 2) ON (B)(6) 2019 AND SUBSEQUENTLY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) BIFURCATION ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RUPTURED MIDLINE ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.7MM, DOME 8.1MM, MAXIMUM ANEURYSM DIAMETER 8.1MM, NECK SIZE 2.8MM, AND DOME-TO-NECK RATIO 2.9MM. THE PARENT VESSEL DIAMETER WAS 2.2MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/UNKNOWN LOT #), ONE 2.5MM X 5CM GALAXY G3 XSFT (GLX122505/ L13333), ONE 2MM X 2CM GALAXY G3 XSFT (GLX120202/L13330), ONE 2.5MM X 4.5CM GALAXY G3 MINI (GLM925045/S15174), ONE 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/L15425), ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L14685), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L15571), TWO 1MM X 2CM GALAXY G3 MINI (GLM910020/L14855), TWO 1MM X 2.5CM GALAXY G3 MINI (GLM910025/L13971), ONE 1MM X 1

  Patient problems: Stroke/CVA

  MAUDE report 10391261 ↗
• MalfunctionJul 6, 2020Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THERE WAS NO MOVEMENT IN THE EXCELSIOR10 MICROCATHETER (MC), THE 2.5MM X 4.5CM GALAXY G3 MINI COIL (GLM925045, 30356229) WAS TIED. THERE WAS NO PATIENT INJURY REPORTED. PICTURES WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10232607 ↗
• MalfunctionMay 4, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-DEPLOYMENT ELECTRICAL CHECK PRIOR TO USE IN THE PATIENT, THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / L14705) WAS CONNECTED TO THE ENPOWER CONTROL CABLE (ECB00018200), BUT THE SYSTEM READY LIGHT DID NOT ILLUMINATE WHEN THE UNIT WAS POWERED ON. THE GALAXY G3 MINI COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. PRELIMINARY PHOTO IMAGES OF THE COMPLAINT DEVICE WERE CAPTURED BY THE J&J (B)(4) AFFILIATES. BASED ON THE REVIEW OF THE PHOTOS BY THE PRODUCT ANALYSIS LAB ON 4/20/2020, THE DEVICE POSITIONING UNIT (DPU) HAS A BEND NEAR THE HUB. THE EMBOLIC COIL IS STILL ATTACHED TO THE RESISTANCE HEATING (RH) COIL, WHICH APPEARS TO BE IN NORMAL, GOOD CONDITION. THE EMBOLIC COIL APPEARS TO BE IN KINKED CONDITION. THE RETURNED MICROCOIL SYSTEM WAS CONNECTED TO THE REFERENCE CABLE AND DETACHMENT CONTROL BOX, THE SYSTEM READY LIGHT ILLUMINATED WHEN IT WAS POWERED ON. THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION¿ BASED ON THE APPEARANCE OF THE EMBOLIC COIL IN THE PHOTO IMAGES OF THE COMPLAINT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022732 ↗
• MalfunctionDec 19, 2019Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM AT THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) WITH SUBARACHNOID HEMORRHAGE (SAH), THE 2.5MM X 4.5CM GALAXY G3 MINI COIL (GLM925045 / L14416) WAS USED; THERE WAS NO ISSUE DURING THE PRE-DEPLOYMENT ELECTRICAL CHECK. HOWEVER, THERE WAS STRONG RESISTANCE WHEN IT WAS DELIVERED TO THE TARGET LESION, DUE TO THE DETACHMENT MARKER ON THE DELIVERY WIRE BEING TOO STIFF. THE COIL WAS INSERTED WITH SOME DIFFICULTY, AND THE DETACHMENT CYCLE WAS INITIATED. THE GREEN LIGHT DID NOT ILLUMINATE, AND THE COIL DID NOT DETACH. THE COIL WAS REPLACED WITH ANOTHER COIL. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR PRODUCT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9498157 ↗
• MalfunctionDec 17, 2019Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 2.5MM X 4.5CM GALAXY G3 MINI COIL (GLM925045 / L14153) WAS NOT ABLE TO CONFORM TO THE SHAPE AS THE PHYSICIAN WANTED; THERE WAS ALSO RESISTANCE AT 1CM FROM THE DISTAL END. THE COIL WAS REPLACED WITH ANOTHER COMPETOR COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9482348 ↗
• MalfunctionAug 15, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THERE WAS A RESISTANCE FELT BETWEEN A 2.5MM X 4.5CM GALAXY G3 MINI (GLM925045, L14223) AND THE INTRODUCER SHEATH WHEN THE COIL DELIVERY SYSTEM WAS INSERTED. THE COMPLAINT PRODUCT WAS REPLACED WITH ANOTHER NEW PRODUCT (GLM925045). THE PROCEDURE CONTINUED AND WAS COMPLETED SAFELY. NO KINK, BEND OR DAMAGE WAS NOTED ON THE DEVICE PRIOR TO USE. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL. BASED ON THE PRODUCT ANALYSIS PERFORMED ON THE DEVICE RECEIVED, THE EMBOLIC COIL WAS STRETCHED AND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897337 ↗
• MalfunctionJun 5, 2019Stretched; Material Deformation; Material Twisted/Bent; Stretched; Material Deformation; Material Twisted/Bent

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF A CEREBRAL ANEURYSM AT THE ANTERIOR CEREBRAL ARTERY, A GALAXY G3 MINI (GLM925045, L14240) WAS INSERTED, HOWEVER, THERE WAS RESISTANCE FELT AT THE HUB WITH THE COIL. THE COIL COULD NOT ADVANCE INSIDE THE SL10, STRYKER MICROCATHETER (MC). THEREFORE, THE COIL WAS REPLACED WITH ANOTHER COIL (GLM925045) AND IT WAS INSERTED INTO THE SAME MICROCATHETER. THERE WAS NO RESISTANCE FELT AND THE PROCEDURE WAS CONTINUED AND COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. INITIALLY, A COIL (5*15 F3) WAS IMPLANTED AS A FRAMING COIL AND FIVE COILS WERE IMPLANTED AFTERWARDS. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. THE GALAXY G3 COIL DELIVERY SYSTEM DID NOT KINK OR BENT PRIOR TO USE. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A GUIDING CATHETER (ROADMASTER, GOODMAN), A CONTROL CABLE (ECB000182-00) AND A DCB2 WERE ALSO U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672144 ↗
• MalfunctionDec 14, 2018Separation Failure; Component Misassembled; Separation Failure; Component Misassembled

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE INTERNAL CAROTID (IC) ARTERY TERMINAL, THE PACKAGE OF THE 2.5MM X 4.5CM GALAXY G3 MINI COIL (GLM925045/L12615) WAS OPENED AND THE MARKER ON THE DETACHMENT POINT WAS LINED UP AND THE DETACHMENT CONTROL BOX WAS PRESSED THREE TIMES, BUT THE COIL COULD NOT BE DETACHED. THE COIL WAS RESHEATHED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE 2.5MM X 4.5CM GALAXY G3 MINI COIL WAS REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8165022 ↗
• MalfunctionDec 13, 2018Retraction Problem; Unraveled Material; Material Twisted/Bent; Retraction Problem; Unraveled Material; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE LEFT INTERNAL CAROTID-POSTERIOR COMMUNICATING (ICPC) ANEURYSM, AFTER THE PLACEMENT OF TWO COMPETITIVE COILS USING THE STRYKER EXCELSIOR®SL-10 STR MICROCATHETER, THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / L13348) WAS USED AS AN ADDITIONAL COIL, AND THE COIL WAS PLACED BUT THE PHYSICIAN HAD DIFFICULTY SEEING THE POSTERIOR COMMUNICATING ARTERY AND DECIDED TO RESHEATH THE COIL. THE PHYSICIAN QUICKLY RETRACTED THE COIL AND THE COIL COULD BE PULLED ONLY HALF WAY. THE PHYSICIAN THEN REMOVED THE COIL WITH THE MICROCATHETER AND ATTEMPTED TO REMOVE THE COIL FROM THE MICROCATHETER OUTSIDE OF THE PATIENT¿S BODY BUT WAS NOT ABLE TO PUSH THE COIL OUT. THE COIL WAS THEN PULLED AND AS A RESULT, IT BECAME UNRAVELED AT THE PROXIMAL END. THE MICROCATHETER WAS REINSERTED INTO THE TARGET LESION AND ANOTHER COMPETITIVE COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160543 ↗

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).