GALAXY G3 GLM910030Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10886704080244), received between Mar 11, 2019 and Apr 28, 2026 — classified as 7 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Failure to Advance; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A LESION ON THE DESCRING COLON TO TREAT A DIVERTICULAR HEMORRHAGE. DEVICES WERE USED ACCORDING TO THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). COIL EMBOLIZATION WAS INITIATED USING A 4FR ANGIOGRAPHIC CATHETER AND AN EXCELSIOR® 1018® MICROCATHETER (STRYKER). THE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 3382503S) WAS USED AS A FINISHING COIL, AFTER IMPLANTATION OF COILS FROM ANOTHER MANUFACTURER. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO DEPLOY THE GALAXY G3 MINI COIL, HOWEVER THE MICROCATHETER POSITION WAS UNSTABLE. THEREFORE, THE COIL WAS RE-SHEATHED AND THE MICROCATHETER POSITION WAS ADJUSTED USING A MICRO GUIDEWIRE. SUBSEQUENTLY, ANOTHER ATTEMPT WAS MADE TO USE THE SAME GALAXY G3 MINI COIL, BUT THE COIL CAUGHT AT THE SHEATH AND DID NOT EXIT FROM THE TIP. THE GALAXY G3 MINI WAS WITHDRAWN AND REPLACED WITH ANOTHER NEW COIL, AND THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO VISIBLE DAMAGE OBSERVED ON THE COIL SHEATH. DURING COIL RE-SHEATHING, THE COIL WAS NOT PULLED BACK BEYOND THE SHEATH PART. IN THE PHYSICIAN¿S OPINION, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023689 ↗
• MalfunctionDec 5, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 1492529S) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED THE COIL AND COMPLETED THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 27-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS STILL ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED, AND IT WAS NOT STRETCHED. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. THE FAULT LIGHT WAS NOT SEEN DURING THE PROCEDURE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED, AND THE AUDIBLE SIGNAL BEEP WAS HEARD. ALL CONNECTIONS FIT WITHOUT APPLICATION OF EXCESSIVE FORCE. THE REPLACEME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735332 ↗
• MalfunctionNov 26, 2025Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, WHEN FILLING THE TARGET SITE WITH COILS, IT WAS FOUND THAT THE COIL, A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 0442502S) WAS UNABLE TO ROTATE RANDOMLY AND THE SHAPE OF THE COIL WAS NOT IDEAL. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A SECOND COIL, A 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 1502509S) AND A THIRD COIL, 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 1112514S) SUCCESSIVELY. THE SECOND AND THE THIRD COIL HAD THE SAME ISSUE AS THE FIRST COIL. THE PHYSICIAN RETRACTED THE COILS AND EVENTUALLY REPLACED IT WITH A FOURTH COIL (UNSPECIFIED COMPETITOR BRAND) TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661059 ↗
• MalfunctionOct 16, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) WAS IN PLACE AND THE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 1352512S) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT IT WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A NEW COIL TO FIL THE ANEURYSM AND DETACHED. AS THE PROCEDURE PROGRESSED, A SECOND COIL, A 1.00MM X 1.00CM GALAXY G3 MINI (GLM910010 / 1112512S) WAS PLACED AND THE SAME DETACHMENT ISSUE WAS ENCOUNTERED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319218 ↗
• MalfunctionJun 25, 2025Stretched; Separation Failure; Stretched; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO A BIFURCATED ANEURYSM, A GALAXY G3 MINI 1MM X 3CM COIL (GLM910030, 30905565) WAS FILLED IN ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR INSPECTED INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECT CABLE, OBSERVED ALL WERE IN GOOD CONDITION. THE DOCTOR PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH. THE DOCTOR RETRACTED THE COIL AND THEN DELIVERED IT TO THE TARGET SITE TO ATTEMPT TO DETACH IT, THE COIL WAS STILL UNABLE TO DETACH. THEN THE DOCTOR ONLY RETRACTED THE COIL ALONE AND TO SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE COIL WAS FOUND UNRAVELED/STRETCHED. THE MICROCATHETER WAS NOT REPLACED. THE DEVICE PACKAGE AND DEVICE WERE INSPECTED PRIOR TO THE PROCEDURE AND FOUND IN GOOD CONDITION. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-JUN-2025 INDICATED THAT THE PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CABLE WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332033 ↗
• MalfunctionMay 1, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1MM X 3CM GALAXY G3 MINI COIL (GLM910030 / 30905561) WAS IMPEDED IN THE PROXIMAL END OF THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. 09-APR-2025, IT WAS INDICATED THAT ADDITIONAL INFORMATION RELATED TO THE DEVICE ISSUE AND PROCEDURE CANNOT BE OBTAINED. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 30-APR-2025, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944050 ↗
• MalfunctionMar 3, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE ANTERIOR CEREBRAL ARTERY (ACA), A GALAXY G3 MINI 1MM X 3CM WAS IMPEDED IN PROXIMAL OF A NON J&J MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE COIL ALONE 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 23-JAN-2025 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WERE NO RELEVANT ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505507 ↗
• MalfunctionFeb 6, 2025Stretched; Failure to Advance; Premature Separation; Stretched; Failure to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30895990) WAS IMPEDED IN THE PROXIMAL SECTION OF THE CONCOMITANT ECHELON¿ 10 MICROCATHETER (MEDTRONIC) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN ATTEMPTED TO RETRACT ONLY THE COIL, BUT THE COIL WAS OBSERVED TO BE UNRAVELED / STRETCHED. THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE, WHICH WAS REPORTEDLY PROLONGED BY APPROXIMATELY 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). A NEUROFORM ATLAS® STENT (STRYKER) WAS USED AS A STENT-ASSIST. THE INFORMATION CONFIRMED THE CONCOMITANT MICROCATHETER WAS THE ECHELON¿ 10 MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO OTHER COILS WENT THROUGH THIS MICROCATHETER PRIOR TO THE COMPLAINT COIL. THE ISSUE OCCURRED DURING ADVANCEMENT INTO THE ANEURYSM. THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL ASIDE FROM THE REPORTED UNRAVELED / STRETCHED CONDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323954 ↗
• MalfunctionMay 21, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE SPINAL ARTERY USING A GALAXY G3 MINI 1MM X 3CM COIL (GLM910030, 30852749), THE COIL SHEATH WAS UNLOCKED PROPERLY. AT FIRST, THE DEVICE ADVANCED SMOOTHLY, BUT MET GREAT RESISTANCE HALFWAY. ATTEMPTED BY TECHNOLOGIST, SCRUB ASSISTANT, AND ATTENDING PHYSICIAN. THERE WAS NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE COIL WAS PULLED OUT AND INSERTED COMPETITOR¿S COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 25-MAR-2024 INDICATING THAT A STRYKER SL-10 STRAIGHT MICROCATHETER (MC) WAS USED. A BALT OPTIBLOCK 1X3 COIL, AND A MEDTRONIC AXIUM 1X2 COIL WERE USED SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO AND AFTER THE ENCOUNTERED RESISTANCE. THE DEVICE DID NOT APPEAR DAMAGED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363175 ↗
• MalfunctionApr 15, 2024Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, A GALAXY G3 MINI 1MM X 3CM COIL (GLM910030, 30878413) WAS JUST DELIVERED INTO A NON-J&J MICROCATHETER, THE DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER SHEATH PREMATURELY. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE, A GALAXY G3 MINI 1MM X 3CM (GLM910030, 30883911) BUT THE SAME ISSUE OCCURRED. THE DOCTOR WITHDREW THE SECOND COIL AND CHANGED TO A THIRD COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-APR-2024 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE INTRODUCER SHEATH SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THERE HAD NOT BEEN ANY ATTEMPTS TO DETACH THE COILS PRIOR TO THE PREMATURE DETACHMENT. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE COILS. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106291 ↗
• MalfunctionApr 15, 2024Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, A GALAXY G3 MINI 1MM X 3CM COIL (GLM910030, 30878413) WAS JUST DELIVERED INTO A NON-J&J MICROCATHETER, THE DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER SHEATH PREMATURELY. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE, A GALAXY G3 MINI 1MM X 3CM (GLM910030, 30883911) BUT THE SAME ISSUE OCCURRED. THE DOCTOR WITHDREW THE SECOND COIL AND CHANGED TO A THIRD COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-APR-2024 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE INTRODUCER SHEATH SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THERE HAD NOT BEEN ANY ATTEMPTS TO DETACH THE COILS PRIOR TO THE PREMATURE DETACHMENT. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE COILS. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106229 ↗
• MalfunctionJan 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30768306) FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509244 ↗
• MalfunctionJan 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30768306) FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509224 ↗
• MalfunctionJan 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30768306) FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509190 ↗
• MalfunctionMay 8, 2023Fluid/Blood Leak; Difficult to Advance; Fluid/Blood Leak; Difficult to Advance

  AS REPORTED BY THE FIELD, PRIOR TO ADVANCEMENT OF A GALAXY G3 MINI 1MM X 3CM (GLM910030, 30742411), THE COIL WAS SEATED INTO THE RHV WHILE BEING HYDRATED BY SALINE. WEEPING WAS VISIBLE FROM THE INTRODUCER SHEATH. DURING THE ADVANCEMENT OF THE COIL, THE TECHNOLOGIST FELT RESISTANCE. THE PHYSICIAN INSTRUCTED THE TECHNOLOGIST TO PULL THE COIL BACK INTO THE INTRODUCER SHEATH. THE COIL WAS INSPECTED, AND NO ABNORMALITIES WERE OBSERVED. A SECOND ATTEMPT WAS MADE TO ADVANCE THE COIL BUT SAME RESISTANCE WAS FELT BY THE TECHNOLOGIST. A NEW COIL OF SMALLER SIZE WAS PITCHED SINCE THIS WAS THE LAST GALAXY G3 MINI 1MM X 3CM. NO ISSUES WERE OBSERVED WITH THIS COIL AND IT ADVANCED THROUGH THE MICROCATHETER SMOOTHLY. ADDITIONAL INFORMATION WAS RECEIVED THAT A STRYKER SL-10 MC STRAIGHT 150CM MICROCATHETER (MC) WAS USED. THERE WAS NO DAMAGE NOTED ON THE SHEATH INTRODUCER, NO SPLIT AND THE DELIVERY WIRE OR COIL WAS NOTED TO BE PROTRUDING FROM THE INTRODUCER. THREE COILS WERE SUCCESSFULLY USED WITH THE SAME MICROCATHETER AFTER THE ENCOUNTERED RESISTANCE. (2) GLM910020 AND (1) GLX120208. IT WAS NO NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THE TARGET VESSEL WAS THE RIGHT MIDDLE MENINGEAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887347 ↗
• MalfunctionMar 22, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WHO WAS SUFFERING FROM A LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM UNDERWENT A STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE. AFTER THE COMPLAINT COIL, A 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30878411) WAS READY TO BE DETACHED, THE PHYSICIAN USED THE DETACHMENT BOX TO DETACH THE COIL IT WAS FOUND THAT THE COIL WAS UNABLE TO DETACH; THE PHYSICIAN MADE ANOTHER ATTEMPT BUT THE COIL STILL FAILED TO DETACH. A NEW COIL WAS USED A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT OR PATIENT COMPLICATION REPORTED. THE COMPLAINT COIL IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS. ON 21-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE CONCOMITANT MICROCATHETER USED WAS AN SL-10® MICROCATHETER (STRYKER); THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THE STENT USED WAS A 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312 / 7121765). THE REPLACEMENT COIL WAS NOT ANOTHER 1MM X 3CM GALAXY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595390 ↗
• MalfunctionMar 22, 2023Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN UNSPECIFIED MICROCATHETER (MC) WAS DELIVERED AND COIL EMBOLIZATION STARTED. A GALAXY G3 MINI 1MM X 3CM COIL (GLM910030, 30392241) WAS USED, HOWEVER, THE COMPLAINT COIL BECAME STUCK ON THE MICROCATHETER. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THIS WAS A PEDIATRIC CASE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE DEVICE WAS NOT ABLE TO BE INSERTED INTO THE HUB OF THE MICROCATHETER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE DEVICE ANALYSIS OF THE PRODUCT RECEIVED, THE EMBOLIC COIL HAD TWO (2) KINK DAMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591924 ↗
• MalfunctionFeb 21, 2023Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1MM X 3CM COIL (GLM910030, 30611667) BECAME IMPEDED IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED OUT. A NEW DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE INVESTIGATION OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS SLIGHTLY STRETCHED AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408868 ↗
• MalfunctionFeb 13, 2023Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION ON THE BASILAR ARTERY (BA) TIP, AFTER THE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) WAS DEPLOYED, COIL EMBOLIZATION WAS INITIATED VIA THE TRANSCELL TECHNIQUE. THE COMPLAINT COIL, A 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30392241) WAS USED AS THE NINTH COIL. THE COIL WAS INSERTED AND EMBOLIZATION INITIATED AS PER THE INSTRUCTIONS FOR USE (IFU). IMAGING WAS TO BE PERFORMED ONCE DURING THE PROCEDURE AND THE COIL WAS REMOVED. THE PHYSICIAN ATTEMPTED TO INSERT THE COIL AGAIN AND TAKEN OUT OF SALINE, BUT THE COIL HAD UNRAVELED. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS MAINTAINED. CONCOMITANT DEVICES USED WERE A FUBUKI GUIDE CATHETER (ASAHI INTECC) AND A PHENOM¿ MICROCATHETER (MEDTRONIC). THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON (B)(6)-2023, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CERENOVUS SALES REPRESENTATIVE THAT THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL (UNSPECIFIED BRAND) AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369218 ↗
• MalfunctionDec 12, 2022Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE INTRODUCER WAS INSERTED INTO A Y-CONNECTOR TO USE A GALAXY G3 MINI 1MM X 3CM COIL (GLM910030, 30622476). HOWEVER, THE COIL WAS UNABLE TO MOVE EVEN THOUGH THE PHYSICIAN ATTEMPTED TO HAVE THE DELIVERY WIRE ADVANCED. THE PROXIMAL INTRODUCER WAS CUT BUT THE SAME ISSUE CONTINUED. THE COIL PART CAME OUT OF THE SLIT OF THE INTRODUCER. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. BASED ON THE VISUAL ANALYSIS OF THE PICTURES RECEIVED, THE EMBOLIC COIL IS SEVERELY STRETCHED AND HAS A KINKED CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960510 ↗
• InjuryDec 8, 2022Stretched; Positioning Problem; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED BASILAR ARTERY (BA) TIP ANEURYSM, THE COMPLAINT PULSERIDER, A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3076825513) WAS PLACED WITHOUT ANY PROBLEM. A CONCOMITANT MICROCATHETER, AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS DELIVERED TO THE TARGET ANEURYSM TO EMBOLIZE FOURTEEN (14) COILS, BUT THE PHYSICIAN ¿POINTED OUT A STRANGE FEELING WHEN INSERTING¿ THE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / K10700), WHICH WAS USED AS THE LAST COIL. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT AND CHECKED; IT WAS OBSERVED TO HAVE UNRAVELED. ¿IT WAS PROBABLY USED AT THE END OF COIL EMBOLIZATION, AND THEREFORE, IT WAS DIFFICULT TO FIT INTO THE ANEURYSM AND UNRAVELED OCCURRED WHEN THE COMPLAINT COIL WAS TAKEN IN AND OUT SEVERAL TIMES.¿ THE COMPLAINT COIL WAS REMOVED AND ¿IMAGED BEFORE DETACHMENT OF THE COMPLAINT PULSERIDER. BECAUSE THE COILS WERE ALSO LOCATED OUTSIDE THE PULSERIDER, THE PULSERIDER WAS DETACHED. DETACHMENT WAS SUCCESS AND DELIVERED AROUND THE LEG WITH THE PROWLER SELECT PLUS MICROCATHETER TO CONFIRM THAT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15944838 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 62-YEAR-OLD FEMALE PATIENT (B)(6) UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY ANTERIOR CIRCULATION ANEURYSM ON (B)(6) 2021. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 6.5MM, DOME 4.2MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 2.9MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.4MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 5MM X 15CM (GLY120515 / L13767), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575 /K10486), A GALAXY G3 XSFT 3MM X 6M (GLX120306 /30399443), A GALAXY G3 MINI 2MM X 6CM (GLM920060 /30366491), A GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /L14642), GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /30393176), GALAXY G3 MIMI 1MM X 3CM (GLM910030 /30422323), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /K10600), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /30390764) AND A 1MM X 1.5CM GALAXY G3 MIMI (GLM910015, 30390761) WERE IMPLANTED. A LVIS STENT (MICROVENTION) WAS ALSO IMPLANTED, AND A BALLOON CATHETER (UNKNOWN CATALOG/MANUFACTURER) WAS ALSO USED. ALL CO

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Vasoconstriction

  MAUDE report 15714082 ↗
• MalfunctionSep 24, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, WHEN THE PHYSICIAN FILLED THE ANEURYSM WITH A 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30490123), THE LAST 1 CM OF THE COIL BECAME IMPEDED IN THE MICROCATHETER AND COULD NO LONGER BE ADVANCED. THE PHYSICIAN RETRACTED THE COIL AND FOUND THAT IT HAD BECOME UNRAVELED / STRETCHED. THEN IT WAS REPORTED THAT THE PHYSICIAN COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT NOR COMPLICATION. THE COMPLAINT ALSO INCLUDED TWO PHOTOS OF THE COMPLAINT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477973 ↗
• MalfunctionAug 25, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION FOR EMERGENCY BLEEDING OF AN ANEURYSM MEASURING 3MM IN THE ANTERIOR COMMUNICATING ARTERY (A-COM). DURING DELIVERY OF A HEADWAY, TERUMO MICROCATHETER (MC), THERE WAS A HEAVY RESISTANCE FELT WITH A 1MM X 3CM GALAXY G3 MINI COIL (GLM910030, 30641962), THE COIL WAS RETRIEVED FROM THE PATIENT¿S BODY. AFTER THAT, A GALAXY G3 MINI COIL OF THE SAME SIZE WAS ABLE TO BE USED WITHOUT ANY PROBLEMS AND THE PROCEDURE WAS COMPLETED. A CONTINUOUS FLUSH WAS DONE. A TARGET 2.5X4 COIL(S) WERE ALSO IMPLANTED. AN INTERMEDIATE CATHETER (GUIDEPOST) WAS USED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293955 ↗
• MalfunctionJul 7, 2022Break; Difficult to Advance; Break; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TARGETING AN ANEURYSM AT THE PERIPHERAL OF THE POSTERIOR INFERIOR CEREBELLA ARTERY (PICA), AFTER DELIVERING THE PHENOM¿ MICROCATHETER (MEDTRONIC), PREPARATION WAS PERFORMED ACCORDING TO THE PROCEDURE. WHEN THE PHYSICIAN ATTEMPTED TO DELIVER THE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30550286) INTO THE MICROCATHETER, THERE WAS A RESISTANCE FELT AROUND THE HUB. THE COIL WAS REMOVED AND WAS NOTED TO BE DEFORMED. A REPLACEMENT COIL WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT CONSEQUENCE OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951921 ↗

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).