GALAXY G3 GLM920030Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10886704080299), received between Jul 13, 2018 and Nov 25, 2025 — classified as 22 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Stretched” (15 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN PULLED THE 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / 1212526S) AND THE CONCOMITANT PROWLER LP ES MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, THE COIL WAS OBSERVED TO BE STRETCHED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. THE PHOTO WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649050 ↗
• MalfunctionJul 16, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 2MM X 3CM COIL (GLM920030, 0352525S) WAS ATTEMPTED TO BE DETACHED 3-4 TIMES. NEVERTHELESS, COIL WAS NOT DETACHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523689 ↗
• MalfunctionJan 27, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A MIDDLE CEREBRAL ARTERY ANEURYSM, THE DEVICES WERE ALL USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). THE 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / 30742414) WAS INSERTED AND AN ATTEMPTED TO BE DETACHED, BUT IT COULD NOT BE DETACHED. THE PHYSICIAN SUSPECTED A PROBLEM WITH THE ENPOWER CONTROL CABLE (ECB00018200 / 31062773) AND REPLACED IT WITH A NEW ENPOWER CONTROL CABLE AND MADE ANOTHER UNSUCCESSFUL ATTEMPT TO DETACH THE COIL. THE 2.00MM X 3.00CM GALAXY G3 MINI WAS RETRIEVED AND REPLACED. THE NEW REPLACEMENT COIL WAS INSERTED, AND IT WAS ABLE TO BE DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 24-JAN-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. ALL CONNECTIONS FIT PROPERLY WITHOUT THE APPLICATION OF EXCESSIVE FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246682 ↗
• 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 21048547 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY (B)(6), A 49-YEAR-OLD MALE (B)(6) WITH NO RELEVANT MEDICAL HISTORY, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, WITH A MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2023. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.8MM, DOME 7MM, MAXIMUM ANEURYSM DIAMETER 8.2MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH EIGHT (8) CERENOVUS COILS: A GALAXY G3 6MM X 15CM (GLY120615/30715066), A GALAXY G3 XSFT 2.5MM X 3.5CM (GLX122535/30563820), A GALAXY G3 MINI 2MM X 3CM (GLM920030/30878377), A GALAXY G3 XSFT 4MM X 8CM (GLX120408/30901816), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/30719529), A GALAXY G3 XSFT 3.5MM X 9CM (GLX123509/30571102), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/30526863), AND A GALAXY G3 MINI 2MM X 4CM (GLM920040/30830570) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED IN THE CRF. IMMEDIATE PO

  Patient problems: Aneurysm

  MAUDE report 19448157 ↗
• MalfunctionJul 25, 2023Positioning Problem; Material Split, Cut or Torn; Positioning Problem; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH), THE COMPLAINT COIL, A 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / 30790688) WAS USED AS USUAL. DURING THE ATTEMPT TO RESHEATH THE COIL, THE SHEATH WAS DAMAGED AND THE COIL COULD NOT BE RETRIEVED. CONTINUOUS FLUSH WAS MAINTAINED. THE PROCEDURE WAS COMPLETED WITH NEW COIL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT REPORTED. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED; IT INDICATED THAT DETAILS RELATED TO THE TARGET VESSEL COULD NOT BE OBTAINED. THE MICROCATHETER, AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS NOT REMOVED WHEN THE COIL WAS REMOVED FOR REPLACEMENT. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REASON THAT LED TO THE NEED TO RESHEATH THE COIL WAS DUE TO POOR COIL CONFORMABILITY. THE INTRODUCER SHEATH ITSELF WAS OPENED AND COULD NOT BE RESHEATHED, NO SPLIT WAS OBSERVED. THERE WAS NO RESISTANCE AT ANY TIME DURING THE COIL ADVANCEMENT THROUGH THE CONCOMITANT MICROCATHETER. THE COIL WAS NOT POSITIONED AT A RELATIVELY SHARP ANGLE TO THE MICROCATHETER. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON (B)(

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393781 ↗
• MalfunctionApr 4, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / 30878419) WAS USED AS THE LAST COIL TO FILL THE ANEURYSM. THE PHYSICIAN TOOK THE COMPLAINT COIL FROM THE DISPENSER HOOP AND INSERTED IT INTO THE Y-CONNECTOR TO FLUSH, THEN DELIVERED THE COIL. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE AND RETRACTED THE COIL; IT WAS OBSERVED THAT THE COIL BECAME UNRAVELED / STRETCHED IN THE MICROCATHETER. A NEW COIL WAS USED AS REPLACEMENT WITH THE ORIGINAL MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679104 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY (CNV_2017_01), A 46-YEAR-OLD FEMALE PATIENT (B)(6) WITH A HISTORY OF HYPERTENSION (CONTROLLED), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY (PCA) SIDE WALL ANEURYSM WITH HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 4.5MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 3.3MM, NECK SIZE 2.1MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PER CRF AND CLINICAL DATABASE, COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: A 3.5MM X 6CM MICRUSFRAME S (L16863), A GALAXY G3 XTRASOFT 3MM X 4CM (GLX120304/L16554), A 2MM X 3CM GALAXY G3 MINI (GLM920030/L30546463), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30546460), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30393176), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/ 30490127) AND A 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/30390770) VIA AN EXCELSIOR SL-10 0165 45 TIP 150 CM MICROCATHETER. HEPARIN HAS BEEN ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE,

  Patient problems: Aneurysm

  MAUDE report 16194864 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16138313 ↗
• MalfunctionDec 12, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 2MM X 3CM COIL (GLM920030, 30490131) WAS USED AS THE SECOND COIL. HOWEVER, THE COIL COULDN¿T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958608 ↗
• MalfunctionNov 21, 2022Break; Break

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE CEREBRAL ARTERY ANEURYSM, A GALAXY G3 MINI 2MM X 3CM COIL (GLM920030, 30383048) WAS USED. THE DELIVERY WIRE WAS ADVANCED, BUT THE INTRODUCER GOT DAMAGED, AND IT WAS IMPOSSIBLE TO INSERT THE COMPLAINT COIL. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE REPLACEMENT COIL WAS INSERTED. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS DISTAL OF THE BASILAR ARTERY. OTHER CONCOMITANT DEVICE IS A MICROCATHETER (EXSELSIOR SL10). NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO RESISTANCE REPORTED. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND SEVERELY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834770 ↗
• MalfunctionJul 8, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, THE 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / L16687) WAS IMPLANTED AND WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, THE ENERGIZING LAMP OF THE DETACHMENT CONTROL BOX DID NOT LIGHT UP AND COIL DETACHMENT FAILED TO OCCUR. THE CONTROL CABLE WAS REPLACED, ANOTHER DETACHMENT ATTEMPT WAS MADE, AND THE ENERGIZING LAMP DID NOT LIGHT UP WITH THE REPLACEMENT CONTROL CABLE. THE COMPLAINT COIL WAS REPLACED. IT WAS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED. THE REPORTED ISSUE DID NOT RESULT IN ANY NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960424 ↗
• InjuryMay 18, 2022Expiration Date Error; Migration; Expiration Date Error; Migration

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

  Patient problems: Aneurysm

  MAUDE report 14427684 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Aneurysm

  MAUDE report 14427643 ↗
• InjuryApr 11, 2022Deformation 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 62-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE (CAD)U, DEEP VEIN THROMBOSIS (DVT) / PULMONARY EMBOLISM (PE), CONTROLLED HYPERTENSION, SMOKING (PREVIOUS), ACUTE KIDNEY FAILURE, INTRACRANIAL ANEURYSMS (TOTAL OF 3 INCLUDING TARGET), CLASS 3 OBESITY (BMI 41 KG/M2), AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM WITH HUNT & HESS GRADE 2 ON 27-OCT-2020. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 4.4 MM, DOME 4.1 MM, MAXIMUM ANEURYSM DIAMETER 5.6 MM, NECK SIZE 2.7 MM, AND DOME-TO-NECK RATIO OF 1.5 MM. THE PARENT VESSEL DIAMETER WAS 1.1 MM. COIL EMBOLIZATION WAS PERFORMED WITH THE FOLLOWING SIX (6) CERENOVUS SPECTRA COILS: A 3.5 MM X 6.6 CM MICRUSFRAME 10 (MFR100356 / L12781), A 2.5 MM X 5 CM GALAXY G3 XSFT (GLX122505 / L14864), A 1.50 MM X 2.50 CM GALAXY G3 MINI (GLM915025 / L15547), A 1.00 MM X 1.50 CM GALAXY G3 MINI (GLM910015 / L13801), A 2.00 MM X 3.00 CM GALAXY G3 MINI (GLM920030 / 30379812), A 1.50 MM X 2.50 CM GALAXY G3 MINI (GLM915025 / L13691), AND ONE (1) COMPETITOR COIL, A 1.5 MM X 2 CM TARGET

  Patient problems: Aneurysm

  MAUDE report 14079276 ↗
• InjuryFeb 22, 2022Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN ACUTE CEREBRAL ANEURYSM, A 2MM X 3CM GALAXY G3 MINI COIL (GLM920030 / UNKNOWN LOT NUMBER) WAS INTENDEDLY DETACHED, BUT THE COIL DEVIATED OUTSIDE OF THE ANEURYSM. THE HERNIATED COIL WAS REMOVED FROM THE PATIENT SAFELY USING A SNARE, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY UNTOWARD EVENTS. THERE WAS NO REPORT OF PATIENT INJURY. THE COMPLAINT DOCUMENTED THAT A GALAXY G3 (SIZE UNKNOWN) WAS IMPLANTED AT THE TARGET ANEURYSM, AND AN ENTERPRISE 2 STENT (UNKNOWN PRODUCT CODE AND LOT NUMBER) WAS THEN DEPLOYED. NEXT, THE PHYSICIAN DETACHED THE COMPLAINT COIL, HOWEVER, THE COIL PROTRUDED OUT OF THE ANEURYSM INTO THE PARENT ARTERY. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION. ON 14-FEB-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ANONYMIZED IMAGES / ANGIOGRAPHS OF THE PROCEDURE ARE NOT AVAILABLE. THE INTENDED PROCEDURE WAS A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE. THE TARGET ANEURYSM WAS ACUTE, BUT NOT RUPTURED. THE REPORTED EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579336 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM AND EXPERIENCED THROMBOEMBOLISM DURING THE PROCEDURE. INTRA-ARTERIAL PRASUGREL, OZAGREL, AND UROKINASE WERE ADMINISTERED AS TREATMENT. THE PHYSICIAN MADE AN ATTEMPT TO RECANALIZE THE LEFT A2 WITH THE GUIDEWIRE AND MICROCATHETER, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE LEFT A2 WAS NOT ABLE TO BE CAPTURED. IMAGING SHOWED SLOW FLOW BUT ENHANCED LEFT A2. IT WAS STATED ¿WHEN THE GUIDEWIRE WAS INDUCED IN THE LEFT IC ON THE SIDE OF THE PATIENT¿S BODY AND IMAGING WAS PERFORMED, IT WAS NOT CONFIRMED AT THE LEFT A2, BUT IT WAS CONFIRMED THAT COLLATERALS DERIVED FROM THE MCA REGION AND THE PERIPHERY OF THE LEFT A2, WHICH WAS ENHANCED FROM THE LEFT IC EARLIER.¿ THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICES INCLUDED A 6F SHUTTLE SHEATH (COOK MEDICAL), 6F CERULEAN DD6 CATHETER (MEDIKIT), REBAR 18 MICROCATHETER (MEDTRONIC), AND SL-10 MICROCATHETER (STRYKER). THE PULSERIDER 10T, 2.7- 3.5MM ANRD (211D/3051697701) WAS DEPLOYED AT THE LEFT A2 PARTIALLY INTRA-ANEURYSMAL (HYBRID APPROACH

  Patient problems: Ischemia Stroke

  MAUDE report 13497472 ↗
• MalfunctionJan 18, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE INTERNAL CAROTID, A GALAXY G3 MINI COIL 2MM X 3CM (GLM920030, 30558131) WAS BEING USED AS A SECOND COIL. IT WAS INSERTED AND ADVANCED WITHOUT ANY PROBLEMS, BUT IT WAS UNABLE TO BE DETACHED. THE DETACHMENT BUTTON OF A CABLE WAS PRESSED SIXTH TIMES, BUT THE COMPLAINT COIL WAS UNABLE TO BE DETACHED. IT WAS REPLACED WITH ANOTHER COIL. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS AND THE SAME CABLE WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS NOT STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. THE EVENT DID NOT PROLONG THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281205 ↗
• MalfunctionJan 12, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 2MM X 3CM COIL (GLM920030, 30546462) WAS BEING USED AS THE THIRD COIL. HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED THE SAME LIKE THE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235635 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) MALE PATIENT WITH A HISTORY OF SMOKING (PREVIOUS) AND MANDIBULAR CANCER UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM ON (B)(6) 2019 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. INTEGRILIN/ASPIRIN WAS ADMINISTERED, AND NEUROFORM ATLAS STENT (STRYKER) WAS IMPLANTED. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2019 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE BIFURCATION ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 7.5MM, DOME 7.2MM, MAXIMUM ANEURYSM DIAMETER 7.5MM, NECK SIZE 5.9MM, AND DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.9MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS COILS: A 7MM X 13.9CM MICRUSFRAME 10 (MFR100713 / L13000), A 7MM X 21CM GALAXY G3 (GLY120721 / L13249), A 5MM X 10CM GALAXY G3 (GLY120510 / L12927), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / L13613), A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / L11233), AND A 2.00MM X

  Patient problems: Thromboembolism

  MAUDE report 13101965 ↗
• InjuryNov 29, 2021Entrapment of Device; Retraction Problem; Stretched; Difficult to Advance; Entrapment of Device; Retraction Problem; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF A RUPTURED INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) ANEURYSM, A 2MM X 3CM GALAXY G3 MINI (GLM920030 / L16250) WAS SELECTED FOR USE AS THE FINISHING COIL, BUT RESISTANCE WAS ENCOUNTERED BETWEEN THE COIL AND CONCOMITANT SL-10® MICROCATHETER (STRYKER) WHEN THE COIL EXITED THE MICROCATHETER. THE FIRST LOOP OF THE COIL ENTERED THE ANEURYSM BLEB, SO THE COIL WAS WITHDRAWN INTO THE MICROCATHETER TO CHANGE THE LOCATION OF PLACEMENT. RESISTANCE WAS ALSO FELT WHEN WITHDRAWING THE COIL INTO THE MICROCATHETER. THE COIL WAS REMOVED FROM THE MICROCATHETER AGAIN, AND THE PHYSICIAN THEN NOTED THAT THE MICROCOIL HAD UNRAVELED. AT THE TIME OF UNRAVELING, THE MICROCATHETER WAS IN THE TARGET ANEURYSM, AND THE COIL SEEMED TO BE IN THE TARGET ANEURYSM ¿A LITTLE¿, SO ALL THE WIRES WERE ATTEMPTED TO BE PUSHED. THE PHYSICIAN PRESSED THE COIL WITH THE WIRE, BUT IT DID NOT MOVE. NEXT, IT WAS PROPOSED TO REMOVE THE COIL AND THE MICROCATHETER AS A UNIT, BUT THE MICROCATHETER WAS STILL FIRMLY INSIDE THE TARGET ANEURYSM AND THERE WAS A RISK THAT THE PREVIOUSLY IMPLANTED COIL (S) WOULD BE PULLED FROM THE ANEURYSM. THEREFORE, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888701 ↗
• MalfunctionOct 19, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI COIL 2MM X 3CM (GLM920030, 30541405) WAS BEING USED AS THE THIRD COIL. HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION. IT TURNS THE COIL WAS STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656045 ↗
• MalfunctionSep 7, 2021Retraction Problem; Stretched; Retraction Problem; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH THE 3.5MM X 6MM ANEURYSM ON THE MIDDLE CEREBRAL ARTERY (MCA), THE 2.00MM X 3.00CM GALAXY G3 MINI COIL (GLM920030 / 30395486) WAS BEING ADVANCED INTO THE ANEURYSM, AND AS IT EXITED THE DISTAL END OF THE CONCOMITANT SL-10® MICROCATHETER (STRYKER), IT LOOKED LIKE IT HAD STRETCHED OUT. THE PHYSICIAN TRIED TO REMOVE THE COIL, BUT IT CAUGHT THE DISTAL END OF THE MICROCATHETER. BOTH COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT. IT WAS CONFIRMED THAT THE COIL WAS REMOVED AND THE PATIENT WAS CHECKED TO VERIFY THAT NO PART OF THE COIL BECAME DETACHED IN THE PATIENT¿S ANATOMY. THE COIL WAS CONFIRMED TO HAVE DETACHED OUTSIDE OF THE PATIENT¿S BODY. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE CONCOMITANT MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. PRIOR TO THE ISSUE ENCOUNTERED WITH THE COMPLAINT COIL, FOUR (4) COILS WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THERE WERE NO KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436843 ↗
• MalfunctionSep 1, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2.00MM X 3.00CM GALAXY G3 MINI COIL (GLM920030 / 30490130) WAS THE SECOND COIL USED IN THE PROCEDURE. THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION OUTSIDE THE PATIENT, THE COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. THE PHYSICIAN USED ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411011 ↗
• InjuryAug 25, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF APPENDECTOMY AND INTRACRANIAL ANEURYSMS (2 TOTAL) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 1) ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 3.9MM, DOME 5.0MM, MAXIMUM ANEURYSM DIAMETER 5.0MM, NECK SIZE 2.5MM, AND DOME-TO-NECK RATIO 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.2MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 4CM GALAXY G3 XSFT (GLX120304 / L16812), TWO 2MM X 3CM GALAXY G3 MINI (GLM920030 / K10499), TWO 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / 30360290), TWO 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10660), AND TWO 1MM X 3CM GALAXY G3 MINI (GLM910030 / K10700) VIA AN SL-10 MICROCATHETER (STRYKER). PER THE INFORMATION DOCUMENTED ON THE CASE REPORT FORM (CRF), ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / K10315) COIL WAS USED BUT NOT IMPLANTED. THERE WAS NO MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) EXPERIENCED. HEPARIN WAS ADMINISTERED DUR

  Patient problems: Aneurysm

  MAUDE report 12368685 ↗

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).