GALAXY G3 GLM910010Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886704080213), received between Aug 29, 2019 and Feb 20, 2026 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (12 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Separation Failure

  DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401600 / 9540635) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). THE PHYSICIAN RETRACTED ONLY THE STENT AND REPLACED IT TO CONTINUE THE PROCEDURE. ANOTHER MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND A 2MM X 2CM GALAXY G3 (GLY120202 / 1042546S) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM AND WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH NEW COILS, A SECOND AND THIRD COIL SUCCESSIVELY, BOTH WERE 1.00MM X 1.00CM GALAXY G3 MINI (GLM910010) FROM THE SAME LOT (1112512S). IT WAS REPORTED THAT BOTH OF THESE COILS WERE ALSO UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE SECOND COIL AND THE THIRD COIL IN SUCCESSION AND REPLACED IT WITH ANOTHER COIL FROM A DIFFERENT MANUFACTURE AND COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE PROCEDURE WAS REPORTEDLY PROLONGED BY ABOUT 10 MINUTES. ON 12-FEB-2026, ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403201 ↗
• MalfunctionFeb 20, 2026Separation Failure

  DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401600 / 9540635) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). THE PHYSICIAN RETRACTED ONLY THE STENT AND REPLACED IT TO CONTINUE THE PROCEDURE. ANOTHER MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND A 2MM X 2CM GALAXY G3 (GLY120202 / 1042546S) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM AND WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH NEW COILS, A SECOND AND THIRD COIL SUCCESSIVELY, BOTH WERE 1.00MM X 1.00CM GALAXY G3 MINI (GLM910010) FROM THE SAME LOT (1112512S). IT WAS REPORTED THAT BOTH OF THESE COILS WERE ALSO UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE SECOND COIL AND THE THIRD COIL IN SUCCESSION AND REPLACED IT WITH ANOTHER COIL FROM A DIFFERENT MANUFACTURE AND COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE PROCEDURE WAS REPORTEDLY PROLONGED BY ABOUT 10 MINUTES. ON 12-FEB-2026, ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403193 ↗
• 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 23689118 ↗
• 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 23319215 ↗
• MalfunctionAug 4, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1MM X 1CM COIL (GLM910010, 0632514S) WAS ATTEMPTED TO BE DETACHED 3-4 TIMES. NEVERTHELESS, THE COIL WAS NOT DETECTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699531 ↗
• 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 22065308 ↗
• MalfunctionFeb 19, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1MM X 1CM COIL ( GLM910010, 30889336) BECAME IMPEDED PROXIMAL OF AN ECHELON10 MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A SECOND NEW COIL TO CONTINUE THE SURGERY AND FILLED THE ANEURYSM SMOOTHLY. WHEN A THIRD COIL WAS DELIVERED, A GALAXY G3 MINI 1MM X 4CM (GLM910040, 30803120), THE SAME ISSUE OCCURRED. THE PHYSICIAN 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 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE DID NOT APPEAR TO BE DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICES RECEIVED, THE EMBOLIC COILS ARE KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413004 ↗
• MalfunctionFeb 19, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1MM X 1CM COIL (GLM910010, 30889336) BECAME IMPEDED PROXIMAL OF AN ECHELON10 MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A SECOND NEW COIL TO CONTINUE THE SURGERY AND FILLED THE ANEURYSM SMOOTHLY. WHEN A THIRD COIL WAS DELIVERED, A GALAXY G3 MINI 1MM X 4CM (GLM910040, 30803120), THE SAME ISSUE OCCURRED. THE PHYSICIAN 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 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE DID NOT APPEAR TO BE DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICES RECEIVED, THE EMBOLIC COILS ARE KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412885 ↗
• MalfunctionDec 31, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) WAS IN PLACE AND THE COIL, A 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / 30889348) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED IN THE ANEURYSM AND WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN INSPECTED THE INDICATOR LIGHT OF THE DETACHMENT BOX AND THE CONTROL CABLE AND OBSERVED ALL WERE IN GOOD CONDITION. THE PHYSICIAN PRESSED THE DETACHMENT BUTTON AND TRIED TO DETACH THE COIL AGAIN, BUT THE COIL STILL DID NOT DETACH. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO THE SECOND COIL, A 1.00MM X 1.00CM GALAXY G3 MINI (GLM910010 / 30889336) TO CONTINUE THE PROCEDURE, BUT THE SECOND COIL ENCOUNTERED THE SAME ISSUE AND FAILED TO DETACH. THE PHYSICIAN RETRACTED THIS SECOND COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 25-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL OF THE PROCEDURE / LOCATION OF THE TARGET ANEURYSM WAS THE MIDDLE CEREBRAL ARTERY (MCA). PER THE INFORMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048549 ↗
• MalfunctionOct 28, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A MICROCATHETER (OTHER BRAND) WAS IN PLACE AND COIL WAS DELIVERED TO TARGET SITE. A GALAXY G3 MINI 1MM X 1CM COIL (GLM910010, 30803117) WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN INSPECTED INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECT CABLE, AND OBSERVED ALL WERE UNDER GOOD CONDITION. THE PHYSICIAN PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH, THEN ONLY RETRACTED THE COIL AND SWITCHED TO NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-OCT-2024 INDICATED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CONTROL CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE COIL DID NOT STRETCH OR BECOME DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WAS A 10-MINUTE PROCEDURAL DAY, HOWEVER, THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546856 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE CORE WIRE AND INTRODUCER SHEATH OF THE 1.00MM X 1.00CM GALAXY G3 MINI COIL (GLM910010 / 30729889) WAS KINKED DURING RESHEATHING. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT. THE PHOTO WAS REVIEWED BY THE PRODUCT ANALYSIS TEAM. [PHOTO REVIEW]: A PHOTO WAS INCLUDED IN THE COMPLAINT WHICH SHOWED THE CORE WIRE PROTRUDING FROM THE INTRODUCER. THE REST OF THE DEVICE IS NOT OBSERVED IN THE PHOTO, AND NO FURTHER DAMAGES COULD BE NOTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30729889 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE CUSTOMER COMPLAINT WAS CONFIRMED. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. 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 ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610886 ↗
• MalfunctionNov 30, 2023Separation Failure; Premature Separation; Separation Failure; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, FOUR COILS WERE DETACHED SUCCESSFULLY IN THE RIGHT MIDDLE CEREBRAL BIFURCATION ANEURYSM. THE LAST COIL, A GALAXY G3 MINI 1MM X 1CM (GLM910010, 30846154) WAS DELIVERED INTO A NON J&J MICROCATHETER (MC) AND FILLED IN THE ANEURYSM. TH PHYSICIAN OBSERVED THE COIL WAS FORMED WELL, THEN TRIED TO DETACH IT, BUT IT COULD NOT BE DETACHED. AFTER TWO DETACHMENTS ATTEMPTS, THE COIL STILL FAILED TO DETACH. THE PHYSICIAN SWITCHED A NEW DETACHMENT CONTROL BOX (DCB)AND ATTEMPTED TO DETACH THE COIL TWICE, THE COIL WAS STILL UNABLE TO DETACH. THE DOCTOR RETRACTED THE COIL AND INTENDED TO CHANGE A NEW COIL. HOWEVER, THE COIL WAS DETACHED IN THE MICROCATHETER. AFTER WITHDREW THE COIL AND MICROCATHETER, THE ANGIOGRAPHY IN THE INTERMEDIATE CATHETER REVEALED THAT THE ANEURYSM WAS WELL FILLED, THEN THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 30-NOV-2023 INDICATED THAT THE SAME DCB WAS USED WITH PRIOR COILS. IT WAS CONFIRMED THAT THE COIL WAS DETACHED IN THE MC. THERE WERE NO PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239578 ↗
• MalfunctionMar 10, 2023Break; Positioning Problem; Break; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION TO TREAT A SUBARACHNOID HEMORRHAGE (SAH), THERE WAS DIFFICULTY WINDING THE COILS INCLUDING THE COMPETITOR TARGET (STRYKER) COILS. IT WAS REPORTED THAT THE COILS WERE UNABLE TO FIT THE TARGET ANEURYSM. THE COMPLAINT COIL, A 1.00MM X 1.00CM GALAXY G3 MINI (GLM910010 / 30485176) WAS REMOVED FROM THE PATIENT¿S BODY AND AN ATTEMPT TO RESHEATH WAS MADE, BUT THE SHEATH WAS REPORTED AS DAMAGED AND THE RESHEATHING WAS NOT POSSIBLE. THE CONCOMITANT MICROCATHETER USED WAS AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). IT WAS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 10-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COMPLAINT COIL FAILED TO CONFORM TO THE ANEURYSM. THERE WAS NO RESISTANCE DURING THE ADVANCEMENT OF THE COMPLAINT COIL THROUGH THE CONCOMITANT MICROCATHETER. THE COIL WAS NOT POSITIONED AT A RELATIVELY SHARP ANGLE TO THE MICROCATHETER. THE INFORMATION INDICATED THAT IT WAS NOT NECESSARY TO REMOVE THE CONCOMITANT MICROCATHETER WHEN THE COMPLAINT COIL WAS REMOVED FROM T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526944 ↗
• MalfunctionNov 14, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1MM X 1CM COIL (GLM910010, 30628967) FAILED TO DETACH IN THE ANEURYSM TWO TIMES. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788286 ↗
• MalfunctionJun 10, 2022Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, PRIOR TO USE, A 1MM X 1CM GALAXY G3 MINI COIL (GLM910010, 30392236) DETACHED BEFORE THE PROCEDURE. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654772 ↗
• MalfunctionFeb 9, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION FOR A 3MM ANTERIOR COMMUNICATING ARTERY (ACOM) SUBARACHNOID HEMORRHAGE (SAH), THE COMPLAINT COIL, A 1.00MM X 1.00CM GALAXY G3 MINI COIL (GLM910010 / 30504533) WAS USED AS THE FOURTH COIL; IT WAS IMPLANTED. HOWEVER, THE COIL WAS UNABLE TO BE DETACHED EVEN THOUGH THE DETACHMENT BUTTON OF THE ENPOWER CABLE WAS PRESSED SEVERAL TIMES. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT AND IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A TOTAL OF FIVE (5) COILS. THE COMPLAINT DOCUMENTED THAT THE PHYSICIAN HAS FAMILIARITY WITH USING THE COMPLAINT COIL. IT WAS PREPPED WITHOUT ANY ISSUES. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CONCOMITANT HEADWAY MICROCATHETER (MICROVENTION). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. IT WAS REPORTED THAT THE COMPLAINT PRODUCT IS NOT AVAILABLE TO BE RETURNED. ON 07-FEB-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; NO STRETCHED CONDITION WAS REPORTED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. UPON PRESSING THE POWER BUTTON, ALL THE LI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498838 ↗
• MalfunctionDec 22, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN TRIED TO DETACH THE 1.00MM X 1.00CM GALAXY G3 MINI COIL (GLM910010 / 30483240) SEVERAL TIMES, BUT THE COIL FAILED TO DETACH. THE PHYSICIAN REMOVED THE COIL AND REPLACED IT. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 17 DEC 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS AN ANEURYSM COILING PROCEDURE. THE COMPLAINT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS NOT STRETCHED WHEN IT WAS REMOVED AND IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE CONCOMITANT MICROCATHETER USED WAS AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER); THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THE INFORMATION ALSO INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. NO FAULT LIGHT WAS SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL THE LIGHTS DID ILLUMINATE AND DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEP WAS HEARD. ALL CONNECTION FIT PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063771 ↗
• InjuryJan 27, 2021Adverse 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 BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT PCA ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.1MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 5.1MM, NECK SIZE 2.0MM, AND DOME-TO-NECK RATIO 1.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406/L16293), ONE 2MM X 2CM GALAXY G3 (GLY120202/L12097), ONE 3MM X 8CM GALAXY G3 MINI (GLM930080/L12616), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L11355), AND ONE 1MM X 1CM GALAXY G3 MINI (GLM910010/L14466) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 24.09% ANGIOSUITE PACKING DENSITY. ACCORDING TO THE CASE REPORT FORM (CRF), THERE WAS NO REPORTED MICROCATHETER KICKBACK. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH MODIFIED RAYMOND-ROY SCORE OF CLASS I: COMPLETE =

  Patient problems: Aneurysm

  MAUDE report 11236982 ↗
• InjuryDec 16, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, THE (B)(6)-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEADACHES, HYPERLIPIDAEMIA (CONTROLLED), HYPERTENSION (10 YEARS HISTORY, CONTROLLED), AND OBESITY (BMI 30 KG/M2) PRESENTED WITH A SUBARACHNOID HEMORRHAGE SECONDARY TO THE TARGET RUPTURED ANEURYSM LOCATED ON THE ANTERIOR CIRCULATION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA); HUNT & HESS GRADE 1. THE PATIENT SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED ANEURYSM ON THE RIGHT BIFURCATION OF THE MCA WITH THE FOLLOWING DIMENSIONS: HEIGHT: 2.5MM, DOME: 3.0MM, DIAMETER: 5.0MM, NECK SIZE 3.0MM, AND DONE TO NECK RATIO: 1MM. THE PARENT VESSEL DIAMETER WAS 2.5.MM. THE COIL EMBOLIZATION PROCEDURE WAS PERFORMED WITH THE IMPLANTATION THE FOLLOWING COILS: ONE 2.50MM X 3.50CM GALAXY G3 MINI (GLM925035 / L12395), ONE 1.50MM X 2.00CM GALAXY G3 MINI (GLM915020 / L12474), ONE 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / L14221), ONE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / L12231), TWO 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020) FROM THE SAME LOT (L14420), AND ONE 1.00MM X 1.00CM GALAXY G3 MINI (GLM910010 / L14466) VIA THE CONCOMITANT SL

  Patient problems: Aneurysm

  MAUDE report 11016641 ↗
• MalfunctionNov 19, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.00MM X 1.00CM (B)(4) ((B)(4)) WAS CHOSEN AS A FILLING COIL, AND THE PHYSICIAN DID NOT PROPERLY JUDGE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RE-SHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 1.00MM X 1.00CM GALAXY G3 MINI 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; No Consequences Or Impact To Patient

  MAUDE report 10872346 ↗
• MalfunctionAug 13, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.00MM X 1.00CM GALAXY G3 MINI COIL (GLM910010 / K10599) WAS THE SECOND COIL CHOSEN TO USE IN THE PROCEDURE TARGETING A 2MM X 1.5MM ANEURYSM. THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. ANOTHER 1.00MM X 1.00CM GALAXY G3 MINI COIL WAS 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 10404776 ↗
• InjuryAug 11, 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 992-012) 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

  Patient problems: Stroke/CVA

  MAUDE report 10391493 ↗
• 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) 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 1.5CM GALA

  Patient problems: Stroke/CVA

  MAUDE report 10391403 ↗
• MalfunctionDec 3, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RUPTURED POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM OF ROUNDABOUT 2MM, THE FIRST COIL WAS TOO BIG, THEN A 2MM X 4CM (GLM920040, L11688) GALAXY G3 MINI WAS CHOSEN. IT WAS PERFECTLY CONFIGURATED IN THE ANEURYSM, SO THEY WANTED TO DETACH, HOWEVER, THE SYSTEM DID NOT DETACH WHEN USING A ENPOWER DCB 2 (DCB2000500, L12008) AND AN ENPOWER CONTROL CABLE (ECB00018200, L11342). THEY USED ANOTHER ENPOWER DCB 2 (DCB2000500, L12008) AND ANOTHER ENPOWER CONTROL CABLE (ECB00018200, L11342, BUT IT DID NOT DETACH. A 1MM X 1CM GALAXY G3 MINI (GLM910010, L11221) WAS ATTEMPTED TO BE DETACHED BUT FAILED. AND A 1.5MM X 2CM GALAXY G3 MINI (GLM915020, L12474) ALSO FAILED TO DETACH. IN TOTAL THEY TRIED 3 DIFFERENT COILS, ALL OF THEM DID NOT DETACH OR DID NOT SHOW THE CONNECTION SIGNAL. THEY CHANGED THE CABLES AND BOXES, BUT NOTHING WORKED. IN TOTAL TWO DCB AND TWO CABLES WERE USED. THE PROCEDURE WAS COMPLETED WITH COMPETITOR¿S COILS. THERE WAS NO REPORT OF THE EVENT RESULTING IN PROLONGATION OF THE PROCEDURE. ADEQUATE FLUSH HAD BEEN MAINTAINED. THE DEVICES WERE PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). PRE-DEPLOYMENT ELECTRI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401468 ↗
• MalfunctionAug 29, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE THAT WAS TARGETING AN ANEURYSM ON THE POSTERIOR COMMUNICATING ARTERY (PCOM), AFTER THE PHYSICIAN SUCCESSFULLY ADVANCED, DETACHED, AND IMPLANTED THE 2MM X 6 CM GALAXY G3 MINI COIL AND THE 1MM X 3CM GALAXY G3 MINI COIL IN THE TARGET LESION VIA THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC), THE 1MM X 1CM GALAXY G3 MINI COIL (GLM910010 / L11046) WAS CHOSEN TO FINISH THE CASE. HOWEVER, THE COIL WOULD NOT ADVANCE INTO THE ECHELON¿ 10 MICROCATHETER. THE DELIVERY WIRE BECAME BENT WITH THE FORCE THAT WAS APPLIED. THE COIL WAS REMOVED, AND THE PHYSICIAN MADE ANOTHER ATTEMPT WITH ANOTHER 1MM X 1CM GALAXY G3 MINI COIL FROM THE SAME LOT, BUT HE ENCOUNTERED THE SAME ISSUE. THE COIL WAS REPLACED WITH THE 1MM X 2CM TARGET® NANO¿ COIL (STRYKER), BUT WHEN IT WAS ADVANCED HALF WAY UP THE MICROCATHETER, IT ALSO BECAME JAMMED. THE MICROCATHETER WAS REMOVED AND THE PHYSICIAN WAITED 20 MINUTES TO SEE IF THE ANEURYSM WAS EMBOLIZED WITH THE PREVIOUSLY IMPLANTED COILS. AFTER THE 20-MINUTE WAIT, A NEW ECHELON¿ 10 MICROCATHETER AND A NEW TARGET® NANO¿ COIL WERE USED TO COMPLETE THE PROCEDURE. THE TARGET POSITION WAS MAINTAINED / REDI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947102 ↗

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).