GALAXY G3 GLM920060Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10886704080312), received between Nov 19, 2018 and Jun 8, 2026 — classified as 11 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Stretched” (28 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 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Stretched

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, WHEN PACKING A GALAXY G3 MINI 2MM X 6CM COIL (PRODUCT CODE: GLM920060, LOT NUMBER: 1832524S) WITHIN THE ANEURYSM, THE DOCTOR OBSERVED AN ABNORMAL COIL CONFIGURATION UNDER IMAGING. THE DOCTOR RETRACTED THE COIL ALONE; THE COIL WAS FOUND TO BE UNRAVELED/STRETCHED. THE DOCTOR SWITCHED TO ANOTHER COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2026 INDICATED THAT PRIOR TO THIS COIL, OTHER COILS HAD BEEN ABLE TO BE ADVANCED THROUGH THE SAME MICROCATHETER. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THE COIL DID NOT PREMATURELY DETACH. THERE WAS NO RESISTANCE/FRICTION ENCOUNTERED WHILE ADVANCING THE COIL. THERE WAS NO RELEVANT ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS OR ANEURYSM CHARACTERISTICS. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428982 ↗
• MalfunctionMay 29, 2026Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE GALAXY G3 MINI 2MM X 6CM (GLM920060/1832524S) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO A NON-J&J MICROCATHETER. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURIES NOR CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE. AN ECHLON 10 MICROCATHETER (NON-J&J) WAS USED. NON-J&J COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER. THE TARGET VESSEL WAS THE INTERNAL CAROTID C6. NO RELEVANT ANATOMICAL INFORMATION WAS INCLUDED. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. CONTINUOUS FLUSH WAS MAINTAINED. 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 OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS CONFIRMED TO BE STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331780 ↗
• MalfunctionMay 13, 2026Device Difficult to Setup or Prepare; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A GALAXY G3 MINI 2MM X 3CM (GLM920030/ 1832511S), GALAXY G3 MINI 2MM X 6CM (GLM920060/ 1832524S), AND A GALAXY G3 MINI 1.5MM X 3CM (GLM915030/ 1612501S) WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED ZIPPING DIFFICULTY & IMPEDED IN MICROCATHETER. THE EVENT WAS REPORTED AS SUCH, ¿ZIPPING DIFFICULTY & IMPEDED IN MICROCATHETER. IT WAS REPORTED THAT DURING PROCEDURE, COIL MICROCATHETER WAS IN PLACE, THEN DELIVERED COIL. DURING PROCESS OF DELIVERING THE COIL, COIL MICROCATHETER (OTHER BRAND) MIGRATED OUT OF THE ANEURYSM. THE DOCTOR ONLY RETRACTED THE COIL ALONE FOR ADJUSTMENT, BUT THE COIL COULD NOT BE RETRACTED TO THE INTRODUCER SHEATH. THE DOCTOR REMOVED THE COIL AND SWITCHED A SECOND COIL, THE SECOND COIL WAS IMPEDED IN THE PROXIMAL END OF THE COIL MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE SECOND COIL ALONE, BUT IT ALSO COULD NOT BE RETRACTED TO THE INTRODUCER SHEATH. THE DOCTOR REMOVED THE SECOND COIL AND COIL MICROCATHETER, THEN SWITCHED A SECOND COIL MICROCATHETER (OTHER BRAND) TO DELIVER A THIRD COIL. THE THIRD COIL WAS PACKED AND DETACHED IN THE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158974 ↗
• MalfunctionApr 16, 2026Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 1832524S) WAS IMPEDED IN THE HUB OF THE ASSOCIATED MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH ANOTHER 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060) FROM LOT: 1612510S. THE SECOND COIL ENCOUNTERED THE SAME ISSUE. THE PHYSICIAN RETRACTED THIS SECOND COIL AND REPLACED IT AGAIN WITH A THIRD COIL AND COMPLETED THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 11-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE INTERNAL CAROTID ARTERY (ICA). THE INFORMATION ALSO INDICATED THAT THERE WAS PARTIAL VESSEL CALCIFICATION. COILS FROM OTHER MANUFACTURERS WERE SUCCESSFULLY USED WITH THE MICROCATHETER AFTER THE REPORTED RESISTANCE WAS ENCOUNTERED. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. DURING THE DEVICE ADVANCEMENT, THE RESPECTIVE INTRODUCERS WERE FIRMLY INSTALLED ONTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV). NO DAMAGE WAS NOTED ON THE DEVICES AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905877 ↗
• MalfunctionApr 16, 2026Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 1832524S) WAS IMPEDED IN THE HUB OF THE ASSOCIATED MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH ANOTHER 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060) FROM LOT 1612510S. THE SECOND COIL ENCOUNTERED THE SAME ISSUE. THE PHYSICIAN RETRACTED THIS SECOND COIL AND REPLACED IT AGAIN WITH A THIRD COIL AND COMPLETED THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 11-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE INTERNAL CAROTID ARTERY (ICA). THE INFORMATION ALSO INDICATED THAT THERE WAS PARTIAL VESSEL CALCIFICATION. COILS FROM OTHER MANUFACTURERS WERE SUCCESSFULLY USED WITH THE MICROCATHETER AFTER THE REPORTED RESISTANCE WAS ENCOUNTERED. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. DURING THE DEVICE ADVANCEMENT, THE RESPECTIVE INTRODUCERS WERE FIRMLY INSTALLED ONTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV). NO DAMAGE WAS NOTED ON THE DEVICES AT A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901248 ↗
• 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 23661065 ↗
• MalfunctionMay 21, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO THE LEFT MAIN CORONARY ARTERY (LMCA), A NON J&J MICROCATHETER WAS PLACED AND A GALAXY G3 MINI 2MM X 6CM COIL (GLM920060, 31136265) 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 ONLY RETRACTED THE COIL ALONE AND SWITCHED TWO NEW COILS CONSECUTIVELY, A GALAXY G3 MINI 1MM X 1CM COIL (GLM910010, 30889337) AND A GALAXY G3 4MM X 7CM (GLY120407, 3162410S). HOWEVER, BOTH COILS HAD THE SAME ISSUE. THE DOCTOR SWITCHED TO A FOURTH COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED AT ALL. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-MAY-2025 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED WITH ALL INVOLVED COILS. THE SAME DETACHMENT CONTROL BOX (DCB) AND THE SAME CABLE WERE USED SUCCESSFULLY WITH THE FOURTH COIL. NO NECK REMODELING WAS UTILIZED. THE COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WAS NO DAMAGE TO THE COILS. THE PROCEDURE WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT, RESULTING IN NO PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065298 ↗
• MalfunctionApr 4, 2025Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THE 2MM X 6CM GALAXY G3 MINI (GLM920060 / 30838878) BECAME DETACHED BEFORE USE. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED. A PHOTO WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21779226 ↗
• MalfunctionNov 15, 2024Fracture; Failure to Advance; Fracture; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30889359) WAS IMPEDED AT THE PROXIMAL END OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED COMPETITOR BRAND). THE PHYSICIAN ONLY RETRACTED THE COIL AND FOUND THAT THE ¿COIL BODY WAS ABOUT TO BREAK.¿ THE PHYSICIAN REPLACED THE COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 30-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING A POSTERIOR COMMUNICATING ANEURYSM. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. PER THE INFORMATION, THE COIL DID NOT END UP BREAKING / FRACTURING INTO TWO OR MORE PIECES, IT WAS AN ¿INCOMPLETE FRACTURE.¿ THE REPLACEMENT COIL WAS ANOTHER 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060). THERE WAS NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700390 ↗
• MalfunctionNov 12, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY, A GALAXY G3 MINI 2MM X 6CM COIL (GLM920060, 30937899) BECAME IMPEDED AT THE PROXIMAL END OF THE MICROCATHETER (OTHER BRAND) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY REMOVED THE COIL FROM THE PATIENT'S BODY AND REPLACED IT WITH A NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. BLOOD VESSEL DIAMETER WAS ABOUT 2.8MM. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS KINKED AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666698 ↗
• MalfunctionJul 25, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY, A GALAXY G3 MINI 2MM X 6CM COIL (GLM920060, 30889359) BECAME IMPEDED AT DISTAL END OF THE MICROCATHETER (OTHER BRAND) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE COIL FROM THE PATIENT'S BODY AND REPLACED IT WITH A NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-JUN-2024 INDICATED THAT THE RESISTANCE WAS FELT DURING ADVANCEMENT. THE RESISTANCE WAS FIRST FELT INSIDE THE INTRODUCER SHEATH. THE TARGET VESSEL HAD NO CALCIFICATION, NO TORTUOSITY. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH 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 OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826296 ↗
• MalfunctionApr 22, 2024Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, THIS WAS A STENT ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM USING PULSERIDER. AFTER APPROACHING WITH 6FR GUIDING CATHETER, DIRECT ACCESS CATHETER (SOFIA 6FR), PROWLER SELECT PLUS AND PHENOM MICROCATHETER, PULSERIDER WAS IMPLANTED (HYBRID IMPLANTATION). THEN, THE PHENOM WAS INSERTED INTO THE ANEURYSM BY TRANSCELL. AFTER 3 J&J COILS WERE IMPLANTED, THE GALAXY G3 MINI 2MM X 6CM COIL (GLM920060, 30637445) WAS ATTEMPTED TO IMPLANT AS A 4TH COIL. THE GALAXY G3 MINI WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), BUT A STRONG RESISTANCE WAS FELT DURING INSERTION INTO THE MICROCATHETER, SO THE GALAXY G3 MINI WAS RETRIEVED. THE COIL WAS FOUND TO BE UNRAVELED OUTSIDE OF THE PATIENT'S BODY. REPLACED WITH ANOTHER NEW COIL FROM ANOTHER LOT NUMBER, WHICH WAS IMPLANTED WITH NO ISSUE. SUBSEQUENTLY, 4 COMPETITOR¿S COILS WERE IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE WAS PHENOM MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-APR-2024 INDICTED THAT THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE INTRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153760 ↗
• MalfunctionApr 1, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO A LEFT MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, A GALAXY G3 MINI 1.5MM X 2CM COIL (GLM915020, 30895987) WAS DELIVERED IN PLACE. FAULT LIGHT WAS ILLUMINATED, AND THE COIL COULDN'T BE DETACHED. A NEW DETACHMENT CONTROL BOX (DCB) AND AN ENPOWER CONNECTING CABLE WERE REPLACED, BUT THE COIL WAS STILL UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL FROM THE PATIENT AND REPLACED IT WITH A GALAXY G3 MINI 2MM X 6CM COIL (GLM920060, 30878424), BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN RETRACTED THE REPLACED THE COIL AND SWITCHED TO ANOTHER BRAND COIL TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. THE PROCEDURE WAS PROLONGED ABOUT 30 MINUTES, THE DELAY WAS NOT CLINICALLY SIGNIFICANT. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-MAR-2024 INDICATED THAT BOTH COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WAS NO DAMAGE TO THE COILS WHEN REMOVED FROM THE PATIENT. THE SPRING RING IS DAMAGED DURING RECOVERY, AND THE SPRING RING CANNOT BE FULLY RECOVERED INTO THE LEAD-IN SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012029 ↗
• MalfunctionDec 15, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30830571) WAS USED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU). AFTER USING A COMPETITOR COIL FOR FRAMING, THE 2.00MM X 6.00CM GALAXY G3 MINI WAS PLANNED TO BE IMPLANTED TOWARD THE END OF THE FILLING. THE 2.00MM X 6.00CM GALAXY G3 MINI WAS INSERTED INTO THE GOODTEC Y- CONNECTOR (GOODMAN), AND THE INTRODUCER WAS ADVANCED UP TO THE CONCOMITANT PHENOM¿ MICROCATHETER (MEDTRONIC). THEN AN ATTEMPT WAS MADE TO DELIVER THE 2.00MM X 6.00CM GALAXY G3 MINI, BUT IT COULD NOT BE DELIVERED. AN ATTEMPT TO PUSH THE COIL OUT OF THE INTRODUCER OUTSIDE OF THE PATIENT, BUT IT WAS ALSO DIFFICULT. THE MICROCATHETER WAS NOT REMOVED NOR REPLACED. CONTINUOUS FLUSH WAS REPORTEDLY NOT MAINTAINED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 INDICATED THAT THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE ADVANCEMENT OF THE DEVICE. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE COIL WAS REPLACED WITH ANOTHER GALAXY G3 MINI AND THE PROCEDURE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341059 ↗
• MalfunctionAug 4, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION PROCEDURE OF A PEDIATRIC CASE, A GALAXY G3 MINI 2MM X 6CMMINI COIL (GLM920060, 30558369) WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND USED AS THE FIRST COIL. WHEN THE GALAXY WAS INSERTED INTO THE UNSPECIFIED MICROCATHETER (MC), THERE WAS A RESISTANCE, AND THE COIL WAS PULLED. REPLACED TO ANOTHER COIL, A GALAXY G3 MINI 2MM X 6CM (GLM920060, 30558133), BUT THE SIZE DID NOT FIT THE LESION, THEREFORE THE SECOND COIL WAS RE-SHEATHED AND THE SHEATH GOT DAMAGED AT THAT TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH COILS WITH DIFFERENT LOT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICES RECEIVED, THE EMBOLIC COIL OF THE FIRST DEVICE IS KINKED AND THE EMBOLIC COIL OF THE SECOND DEVICE IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459840 ↗
• MalfunctionAug 4, 2023Break; Break

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION PROCEDURE OF A PEDIATRIC CASE, A GALAXY G3 MINI 2MM X 6CMMINI COIL (GLM920060, 30558369) WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND USED AS THE FIRST COIL. WHEN THE GALAXY WAS INSERTED INTO THE UNSPECIFIED MICROCATHETER (MC), THERE WAS A RESISTANCE, AND THE COIL WAS PULLED. REPLACED TO ANOTHER COIL, A GALAXY G3 MINI 2MM X 6CM (GLM920060, 30558133), BUT THE SIZE DID NOT FIT THE LESION, THEREFORE THE SECOND COIL WAS RE-SHEATHED AND THE SHEATH GOT DAMAGED AT THAT TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH COILS WITH DIFFERENT LOT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICES RECEIVED, THE EMBOLIC COIL OF THE FIRST DEVICE IS KINKED AND THE EMBOLIC COIL OF THE SECOND DEVICE IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459819 ↗
• MalfunctionJun 30, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT AFTER TWO TARGET XLS WERE INSERTED AND INJECTED NBCA, THE GALAXY G3 2MM X 6CM (GLM920060/ 30641970) COIL WAS INSERTED. THE G3 COIL WAS REMOVED DUE TO STRONG RESISTANCE DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH G3 XSFT COIL. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238887 ↗
• 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 17132002 ↗
• 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 17132001 ↗
• MalfunctionMay 17, 2023Positioning Problem; Material Split, Cut or Torn; Positioning Problem; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO A CEREBRAL ANEURYSM, A GALAXY G3 MINI 2MM X 6CM COIL (GLM920060, 30649237) WAS INSERTED, BUT FAILED TO CONFORM TO THE ANEURYSM WALL. WHILE ATTEMPTING TO RETRIEVE IT, THE SHEATH PART WAS TORN OFF AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE COMPETITOR¿S COIL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO NECK REMODELING UTILIZED. THE MICROCOIL WAS NOT POSITIONED AT A RELATIVELY SHARP ANGLE TO THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945975 ↗
• MalfunctionApr 28, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE THAT WAS TARGETING A BLEEDING IN THE ABDOMINAL MICROVASCULAR, A 2.00MM X 6.00CM GALAXY G3 MINI COIL (GLM920060 / 30407101) WAS USED AND IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED DURING THE PROCEDURE. AFTER SEVERAL ATTEMPTS, THE COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PUSHABLE COILS. IT WAS REPORTED THAT THE PHYSICIAN COMMENTED THAT CHANGING THE ENPOWER CONTROL CABLE MIGHT HAVE RESOLVED THE ISSUE, BUT HE DID NOT CHANGE THE CABLE. IT WAS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16840201 ↗
• 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 (SUBJECT (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 USE

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Vasoconstriction

  MAUDE report 15714163 ↗
• MalfunctionOct 12, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE VERTEBRAL ARTERY, THE POSITION OF A 2MM X 6CM GALAXY G3 COIL (GLM920060, 30579189) WAS NOT ACCURATE. THE PHYSICIAN TRIED TO RETRACT AND ADJUST THE COIL, BUT THE COIL WAS IMPEDED IN INTRODUCER SHEATH AND COULD NOT ADVANCE ANY MORE. A NEW COIL WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER (MC). THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. 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 ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND SEVERELY STRETCHED INSIDE THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587356 ↗
• MalfunctionOct 6, 2022Failure to Advance; Separation Failure; Failure to Advance; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE 2.00MM X 6.00CM GALAXY G3 MINI COIL (GLM920060 / K10502) WOULD NOT ADVANCE THROUGH THE MICROCATHETER AND WOULD NOT DETACH. IT WAS REPORTED THAT THERE WAS A DELAY IN THE PROCEDURE, THE DURATION OF THE DELAY WAS NOT REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551188 ↗
• MalfunctionSep 19, 2022Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN FELT STRONG RESISTANCE DURING THE ADVANCEMENT OF THE 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30628972) THROUGH THE 150CM X 5CM, 2 MARKERS, 90 TIP PROWLER SELECT LPES MICROCATHETER (606S155MX / 30731158). THE COIL BECAME PREMATURELY DETACHED IN THE MICROCATHETER. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15452285 ↗

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).