GALAXY G3 GLM915025Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886704080121), received between Jun 13, 2019 and May 1, 2025 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 2.5CM COIL (GLM915025, 30852755) DID NOT DISCONNECT. THE USER CHANGED THE DETACHMENT CONTROL BOX (DCB) AND THE CONNECTING CABLE, BUT IT IS THE SAME. THE POWER IS NOT DISCONNECTED. THE COIL WAS EXCHANGED FOR ANOTHER NON J&J PRODUCT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942723 ↗
• MalfunctionMar 19, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 2.5CM COIL (GLM915025, 30937886) BECAME IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO MICROCATHETER (MC). THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642968 ↗
• InjuryJan 8, 2024Deformation Due to Compressive Stress; Migration; Deformation Due to Compressive Stress; Migration

  AS REPORTED VIA THE STERLING REGISTRY (B)(6) , CATHETER ANGIOPLASTY DEMONSTRATED COIL COMPACTION WITH A GALAXY G3 MINI COIL 1.5MM X 2.5CM (GLM915025, 30383043) AS WELL AS COIL MIGRATION WITH A SINGLE LOOP THAT HAS MIGRATED SEPARATELY FROM THE COIL BODY AND INTO THE OSTIUM OF THE LEFT A2 SEGMENT. THE DEVICE DEFICIENCY DID NOT RESULT IN A SERIOUS ADVERSE EVENT. THIS WAS A COIL EMBOLIZATION TO A RUPTURED TARGET ANEURYSM AT THE LEFT ANTERIOR COMMUNICATING ARTERY WITH A 1.3MM PARENT VESSEL DIAMETER, 5MM HEIGHT AND 3MM DOME. THE MAXIMUM ANEURYSM DIAMETER WAS 3.5MM, NECK SIZE WAS 1.3MM AND THE DOME TO NECK RATION WAS 2.3MM. THE COIL REMAINS IMPLANTED. TWO STUDY GALAXY G3 MINI 2.5MM X 5.5CM COIL AND A GALAXY G3 4MM X 7CM COIL WERE ALSO SUCCESSFULLY IMPLANTED. THERE WAS NO KICKBACK EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464150 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY (B)(4), 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, AND THE

  Patient problems: Aneurysm

  MAUDE report 16194885 ↗
• MalfunctionOct 5, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, A 1.50MM X 2.50CM GALAXY G3 MINI (GLM915025 / 30393175) WAS THE SECOND COIL USED. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, THE COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. THE PHYSICIAN USED A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547768 ↗
• 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 (B)(6) 2020. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 4.4MM, DOME 4.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.7MM, AND DOME-TO-NECK RATIO OF 1.5MM. THE PARENT VESSEL DIAMETER WAS 1.1MM. COIL EMBOLIZATION WAS PERFORMED WITH THE FOLLOWING SIX (6) CERENOVUS SPECTRA COILS: A 3.5MM X 6.6CM MICRUSFRAME 10 (MFR100356 / L12781), A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / L14864), A 1.50MM X 2.50CM GALAXY G3 MINI (GLM915025 / L15547), A 1.00MM X 1.50CM GALAXY G3 MINI (GLM910015 / L13801), A 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / 30379812), A 1.50MM X 2.50CM GALAXY G3 MINI (GLM915025 / L13691), AND ONE (1) COMPETITOR COIL, A 1.5MM X 2CM TARGET HELICAL NANO COIL (

  Patient problems: Aneurysm

  MAUDE report 14079275 ↗
• 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 (B)(6) 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 (B)(6) 2020. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 4.4MM, DOME 4.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.7MM, AND DOME-TO-NECK RATIO OF 1.5MM. THE PARENT VESSEL DIAMETER WAS 1.1MM. COIL EMBOLIZATION WAS PERFORMED WITH THE FOLLOWING SIX (6) CERENOVUS SPECTRA COILS: A 3.5MM X 6.6CM MICRUSFRAME 10 (MFR100356 / L12781), A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / L14864), A 1.50MM X 2.50CM GALAXY G3 MINI (GLM915025 / L15547), A 1.00MM X 1.50CM GALAXY G3 MINI (GLM910015 / L13801), A 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / 30379812), A 1.50MM X 2.50CM GALAXY G3 MINI (GLM915025 / L13691), AND ONE (1) COMPETITOR COIL, A 1.5MM X 2CM TARGET HELICAL NANO COI

  Patient problems: Aneurysm

  MAUDE report 14079267 ↗
• MalfunctionApr 7, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE PHYSICIAN WAS NOT ABLE TO INSERT A GALAXY G3 MINI 1.5MM X 2.5CM COIL (GLM915025, S15171) OR A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, L11005). INTO THE HUB OF ECHELON14 (14/105-5092-150) TIP STRAIGHT MICROCATHETER (MEDTRONIC). THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS DELAYED BY 15 MINUTES OR MORE DUE TO THE EVENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE HAD BEEN NO EXCESSIVE FORCE APPLIED TO THE DEVICES. IT WAS NO NECESSARY TO REMOVE CONCOMITANT DEVICES WITH THE COMPLAINT DEVICE. THERE WERE NO DEVICE FRAGMENTS THAT REMAINED IN THE PATIENT. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. A TARGET AND AXIUM COILS (WITH BIGGER DIAMETER) WERE USED SUCCESSFULLY WITH THE SAME MICROCATHETER (MC). THE EVENTS DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MC WAS NOT DAMAGED DURING MANIPULATION OF THE COILS OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. NOTHING WAS NOTED TO BE OBSTRUCTING THE MC. THE INTRODUCER W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043254 ↗
• MalfunctionSep 2, 2021Separation Failure; Separation Failure

  DURING THE USE OF A 1.5MM X 2.5CM GALAXY G3 MINI COIL (GLM915025, L14363), AN ENPOWER CONTROL CABLE (ECB00018200, 30473616) WAS CONNECTED BUT THE POWER LUMP DID NOT ILLUMINATE. THE COMPLAINT COIL AND THE COMPLAINT CABLE WERE REPLACED WITH OTHER DEVICES. IT WAS CONFIRMED THAT THE FAILURE DID NOT OCCUR DURING PRE-DEPLOYMENT ELECTRICAL CHECK. THE REPLACED CABLE WAS SUCCESSFULLY USED WITH THE SUBSEQUENT COILS. THE COIL DID NOT STRETCH OR WAS DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WAS NO SIGNIFICANT PROLONGATION IN THE PROCEDURE DUE TO THE EVENTS. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414439 ↗
• InjuryDec 2, 2020Deformation 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

  AS REPORTED BY THE STERLING STUDY, A (B)(6)-YEAR OLD MALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES, CONTROLLED HYPERTENSION, CONTROLLED HYPERLIPIDEMIA, MYOCARDIAL INFARCTION (MI), SUBARACHNOID HEMORRHAGE SECONDARY TO RUPTURED TARGET ANEURYSM ((B)(6) 2019), AND BENIGN PROSTATIC HYPERPLASIA (BPH) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RECURRENT BASILAR ARTERY ANEURYSM ON (B)(6) 2020. THE TARGET ANEURYSM HAD BEEN PREVIOUSLY TREATED WITH UNSPECIFIED COILS ON (B)(6) 2019. 180-DAY (6-MONTH) FOLLOW-UP MAGNETIC RESONANCE ANGIOGRAPHY (MRA) PERFORMED ON (B)(6)2020 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSMAL SAC. RETREATMENT OF THE TARGET ANEURYSM WAS SUBSEQUENTLY PERFORMED DUE TO RESIDUAL NECK ON (B)(6) 2020. TWO COMPETITOR COILS WERE IMPLANTED WITH RAYMOND-ROY CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE ADVERSE EVENTS OR STUDY DEVICE DEFICIENCIES. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED AN UNRUPTURED BASILAR ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.6MM, DOME 4.

  Patient problems: Aneurysm

  MAUDE report 10936362 ↗
• MalfunctionSep 9, 2020Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING AN EMERGENT COIL EMBOLIZATION FOR SUBARACHNOID HEMORRHAGE (SAH), A 1.5MM X 2.5CM GALAXY G3 MINI COIL (GLM915025, L14363) WAS USED AS THE EIGHTH COIL BUT THERE WAS AN INTENSIVE RESISTANCE FELT WHEN IT ADVANCED THROUGH AN UNSPECIFIED CONCOMITANT MICROCATHETER (MC). THEY WERE REMOVED FROM THE PATIENT AND THE MICROCATHETER WAS FLUSHED. THE PHYSICIAN TRIED AGAIN BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZED COIL AND THE PROCEDURE COMPLETED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507452 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Stroke/CVA

  MAUDE report 10391232 ↗
• InjuryMay 14, 2020Entrapment of Device; Premature Separation; Entrapment of Device; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN SUDDENLY COULD NOT ACCESS OR RETRIEVE THE 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/L11158) COIL. IT WAS ¿JAMMING¿ IN THE EXCELSIOR SL-10 (STRYKER) MICROCATHETER WHEN THE COIL HAD ALREADY EXITED THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL, BUT A PREVIOUSLY PLACED TARGET (STRYKER) COIL CAME OUT TOGETHER WITH THE COMPLAINT COIL; THEREFORE, A STENT HAD TO BE IMPLANTED TO ADHERE THE TARGET COIL TO THE VESSEL WALL. THE COMPLAINT COIL WAS WITHDRAWN BUT PREMATURELY DETACHED IN THE MICROCATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. THE EVENT RESULTED IN A SURGICAL DELAY, BUT THE LENGTH OF THE DELAY IS CURRENTLY UNKNOWN. A POWERPOINT PRESENTATION CONTAINING PROCEDURAL IMAGING WAS PROVIDED AND WILL BE FORWARDED TO AN INDEPENDENT PHYSICIAN FOR REVIEW. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10057072 ↗
• InjuryMar 17, 2020Material Separation; Separation Failure; Material Separation; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE BALLOON-ASSISTED COIL EMBOLIZATION PROCEDURE OF A 4MM ANEURYSM AT THE RIGHT INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC), A 3MM X 4CM HYDROSOFT® COIL ((MICROVENTION-TERUMO) WAS USED AS A FRAMING COIL AND A 2.5MM X 3CM ED COIL (KANEKA MEDICAL PRODUCTS) WAS USED AS A FILLING COIL BEFORE THE 1.50MM X 2.50CM GALAXY G3 MINI COIL (GLM915025 / L13810) WAS CHOSEN AND POSITIONED IN THE TARGET ANEURYSM AS THE FINISHING COIL; HOWEVER, THE COIL FAILED TO DETACH AFTER THE PHYSICIAN MADE FOUR DETACHMENT ATTEMPTS USING THE ENPOWER CONTROL CABLE (ECB00018200 / L16610). THE PHYSICIAN REPLACED THE ENPOWER CONTROL CABLE WITH ANOTHER FROM THE SAME LOT (L16610) AND MADE THREE ADDITIONAL UNSUCCESSFUL ATTEMPTS TO DETACH THE COIL. THE PHYSICIAN DECIDED TO REMOVE THE COIL FROM THE PATIENT WHEN THE COIL BECAME SEPARATED INSIDE THE SL-10® MICROCATHETER (STRYKER). IT WAS REPORTED THAT THE COIL WAS FLOATING IN THE BLOOD VESSEL. THE PHYSICIAN REMOVED THE SEPARATED COIL USING A SNARE AND A HEADWAY® 21 MICROCATHETER (MICROVENTION-TERUMO) WHEN THE COIL MASS OF THE FILLING COIL (2.5MM X 3CM ED COIL) BECAME UNRAVELED. AN LVIS® STENT (MICROVENTION-TERUMO

  Patient problems: No Code Available

  MAUDE report 9845672 ↗
• MalfunctionAug 13, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION FOR THE SUBARACHNOID HEMORRHAGE (SAH) ANEURYSM, AFTER THE PHYSICIAN INSERTED THE INTRODUCER SHEATH OF A 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025, L11732) INTO THE Y CONNECTOR AND IT WAS FIRMLY FIXED TO THE HUB OF THE MICROCATHETER, THE PHYSICIAN ATTEMPTED TO DELIVER THE WIRE. HOWEVER, THERE WAS RESISTANCE FELT BETWEEN THE COMPLAINT PRODUCT AND THE DELIVERY WIRE, THE DEVICE WAS ¿STUCK¿ DUE TO THE RESISTANCE. AFTER THAT, THE PHYSICIAN ATTEMPTED TO INSERT THE COMPLIANT PRODUCT TO THE SHEATH, HOWEVER THE COMPLAINT PRODUCT DID NOT COME OUT FROM THE DISTAL END OF THE SHEATH INTRODUCER. THEREFORE, THE COMPLAINT PRODUCT WAS REPLACED WITH ANOTHER PRODUCT AND THE PROCEDURE COMPLETED SAFELY. NO EXCESSIVE FORCE HAD BEEN APPLIED TO ATTEMPT TO UN-ZIP OR RE-ZIP THE INTRODUCER. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL. BASED ON THE DEVICE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889303 ↗
• MalfunctionJun 13, 2019Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A LEFT OPHTHALMIC ANEURYSM (3X4MM), THERE WAS DIFFICULTY PLACING TWO GALAXY G3 COILS. THE MICROCATHETER USED WAS AN SL10. THE USER ENTERED INTO THE ANEURYSM WITHOUT DIFFICULTY. THE FIRST GALAXY G3 COIL (GLX123505, L10142) CONFORMED WELL WITHIN THE ANEURYSM UNTIL THE LAST COIL LOOP, THE LAST LOOP DEPLOYED. IT PUSHED THE MICRO CATHETER OUT OF THE ANEURYSM. AFTER TRYING 3 TIMES, THE COIL WAS REMOVED AND REPLACED WITH A NON-CERENOVUS 3.5 X8 XTRA SOFT COIL WITHOUT ANY ISSUE. THEN ANOTHER NON-CERENOVUS 2X6CM COIL WAS PLACED WITHOUT ANY ISSUE. THE NEXT COIL WAS A GALAXY G3 MINI (GLM915025, UNKNOWN LOT). THE COIL WENT IN FINE UNTIL THE LAST LOOP AND KICKED THE MICROCATHETER BACK. THE USER TRIED 3 -4 TIMES AND REMOVED THE COIL. A NON-CERENOVUS COIL WAS PLACED IN WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS SURGERY DELAY DUE TO THE EVENTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696229 ↗

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).