GALAXY G3 GLM910015Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886704080206), received between Aug 15, 2019 and Jun 14, 2023 — classified as 6 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2023Migration; Migration

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 32-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION AND MILD INTERMITTED ASTHMA UNDERWENT COIL EMBOLIZATION TO TREAT A RUPTURED ANEURYSM LOCATED IN THE BIFURCATION OF THE LEFT ANTERIOR COMMUNICATING ARTERY ON (B)(6)2023. THE PRE-PROCEDURE HUNT & HESS GRADE WAS 3, AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT OF 2.7MM, DOME OF 3.4MM, MAXIMUM ANEURYSM DIAMETER OF 3.4MM, NECK SIZE OF 2.7MM, AND DOME-TO-NECK RATIO OF 1.3MM. THE PARENT VESSEL DIAMETER WAS 2.5MM. THE COIL EMBOLIZATION WAS PERFORMED WITH THREE (3) CERENOVUS COILS: A 2.5MM X 3.3CM MICRUSFRAME 10 (MFR100253 / 30956212), A 2MM X 2CM GALAXY G3 XSFT (GLX120202 / 30641974), AND A 1.00MM X 1.50CM. GALAXY G3 MINI (GLM910015 / 30838865) AS THE THIRD COIL VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). AFTER DETACHMENT OF THE THIRD COIL, WHILE THE MICROCATHETER WAS BEING RETRIEVED, THE LAST LOOPS OF THE THIRD COIL BECAME PROLAPSED OUT OF THE ANEURYSM AND INTO THE PARENT VESSEL. THERE WERE COIL LOOPS WITHIN THE PARENT VESSEL WHICH DEMONSTRATE DISPLACEMENT DURING THE CONTRAST INJECTION. AS A RESULT, A NEUROFORM ATLAS® STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131878 ↗
• MalfunctionMar 28, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, AN APPROACH WAS MADE FROM THE FEMORAL ARTERY. A GUIDING CATHETER WAS DELIVERED TO THE INFERIOR COLLICULUS (IC) AND A DAC WAS DELIVERED TO THE INTERNAL CAROTID ARTERY (ICA). A HEADWAY17 WAS DELIVERED TO THE MIDDLE CEREBRAL ARTERY (MCA) FROM THE DAC AND A MICROCATHETER (PHENOM17) WAS DELIVERED INTO THE ANEURYSM BY JAIL. A LVIS JR STENT WAS DEPLOYED HALF AND COIL EMBOLIZATION STARTED. THE GALAXY G3 MINI 1MM X 1.5CM COIL (GLM910015, 30656491) WAS USED BUT THERE WAS RESISTANCE FELT WHEN PUSHED INSIDE THE INTRODUCER. THE COMPLAINT COIL WAS RETRACTED, AND THE PHYSICIAN FOUND THE COMPLAINT COIL UNRAVELED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME-SIZED COIL AND COIL EMBOLIZATION WAS COMPLETED. THE STENT WAS DEPLOYED FULLY, AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAS BEEN STABLE. A CONTINUOUS FLUSH WAS DONE. CONCOMITANT PRODUCTS USED: FUBUKI GS XF, 6F SOFIASELECT, CHIKAI14, SYNCHORO SELECT, HEADWAY17, PHENOM17 AND LVIS JR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628659 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Vasoconstriction

  MAUDE report 15714172 ↗
• 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) 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 (STRYKE

  Patient problems: Aneurysm

  MAUDE report 14079282 ↗
• MalfunctionMar 21, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.00MM X 1.50CM GALAXY G3 MINI COIL (GLM910015 / 30386742) FAILED TO DETACH AFTER IT WAS DEPLOYED INTO THE ANEURYSM. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THERE WAS NO PROCEDURE DELAY FROM THE REPORTED EVENT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840775 ↗
• MalfunctionMar 1, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI COIL 1MM X 1.5CM (GLM910015, 30412522) WAS BEING USED AS THE FOURTH COIL. 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 A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636356 ↗
• 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 1.50CM GALAXY G3 MINI COIL (GLM910015 / 30396204) 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 13063827 ↗
• InjuryJul 15, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF CONTROLLED HYPERTENSION, ACTIVE SMOKING, ARTHRITIS, ASTHMA, FIBROMYALGIA, OSTEOPOROSIS, IRRITABLE BOWEL SYNDROME (IBS), AND UNRUPTURED LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED RIGHT MCA BIFURCATION ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 2) ON (B)(6) 2019. DURING THE PROCEDURE, THERE WAS A THROMBOEMBOLIC EVENT WHICH NECESSITATED THE ADMINISTRATION OF AGGRASTAT AS MEDICAL INTERVENTION. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. PER THE INFORMATION ENTERED IN ELECTRONIC DATA CAPTURE (EDC), THE EVENT WAS DEEMED RELATED TO THE STUDY PROCEDURE WITH A CHANCE OF PROBABLE RELATIONSHIP TO THE DEVICE. ON (B)(6) 2020, THE PATIENT UNDERWENT REPEAT BALLOON-ASSISTED COIL EMBOLIZATION OF THE TARGET ANEURYSM DUE TO RESIDUAL ANEURYSM. COMPETITOR COILS WERE IMPLANTED WITH COMPLETE ANEURYSM OBLITERATION. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RUPTURED RIGHT MCA BIFURCATION ANE

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 12174427 ↗
• MalfunctionNov 6, 2020Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.00MM X 1.50CM GALAXY G3 MINI COIL (GLM910015 / L15534) 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 RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 1.00MM X 1.50CM 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 10803562 ↗
• 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 10391472 ↗
• 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 10391383 ↗
• MalfunctionJul 7, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 1.00MM X 1.50CM GALAXY G3 MINI COIL (GLM910015 / L12394) WAS USED BUT IT COULD NOT BE DETACHED. THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10240127 ↗
• MalfunctionJul 6, 2020Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THERE WAS NO MOVEMENT IN THE EXCELSIOR10 MICROCATHETER (MC), THE 1MM X 1.5CM GALAXY G3 MINI COIL (GLM910015, L16005). THERE WAS NO PATIENT INJURY REPORTED. A PICTURE WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10232702 ↗
• MalfunctionMar 16, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.00MM X 1.50CM GALAXY G3 MINI COIL (GLM910015 / L15175) WAS THE THIRD COIL USED IN THE PROCEDURE; IT WAS REPORTED THAT 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. THE PHYSICIAN USED ANOTHER 1.00MM X 1.50CM GALAXY G3 MINI COIL 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 9836595 ↗
• MalfunctionNov 4, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 1MM X 1.5CM GALAXY G3 MINI COIL (GLM910015, L12717) WOULD NOT ADVANCE OUT OF SHEATH -RESISTANCE WITH THE PROPER PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE FINDINGS OF THE DEVICE INVESTIGATION, THE EMBOLIC COIL WAS NOTED TO BEING KINKED/STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9271587 ↗
• MalfunctionAug 15, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A CEREBRAL COIL EMBOLIZATION OF A UNRUPTURED ANEURYSM, A 1MM X 1.5CM GALAXY G3 MINI WAS ATTEMPTED TO BE IMPLANTED TO THE TARGET LESION, BUT THERE WAS A HEAVY RESISTANCE FELT BETWEEN THE PRODUCT AND THE DISTAL TIP OF THE MICROCATHETER WHEN THE DEVICE WAS JUST BEFORE COMING OUT OF THE MICROCATHETER. THE COMPLAINT PRODUCT WAS REMOVED FROM THE PATIENT¿S BODY AND THE PROCEDURE WAS COMPLETED. INITIALLY, A MICROCATHETER WAS APPROACHED TO THE TARGET LESION AND A THE 5X10 G3 COIL WAS USED FOR FRAMING. THEN, THE FOLLOWING COILS WERE IMPLANTED, 5X10 G3 COIL, 3X6 G3 MINI COIL, 3X6 TARGET COIL, AND A 1.5X3 G3 MINI COIL. NO KINK OR BEND WAS CONFIRMED PRIOR TO USE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE. BASED ON THE DEVICE INVESTIGATION OF THE PRODUCT RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897585 ↗

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).