GALAXY G3 GLM910025Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704080220), received between Nov 9, 2018 and Sep 21, 2021 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1MM X 2.5CM COIL (GLM910025, L13803) WAS BEING USED AS THE FORTH 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 A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505453 ↗
• MalfunctionAug 27, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.00MM X 2.50CM GALAXY G3 MINI COIL (GLM910025 / 30366482) WAS THE FOURTH (4TH) COIL IN THE PROCEDURE. THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AT THE SAME TIME. AFTER INSPECTION, THE COIL WAS OBSERVED IN STRETCHED CONDITION. IT WAS REPORTED THAT THE PHYSICIAN USED ¿A SAME LIKE PRODUCT¿ 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 12380503 ↗
• MalfunctionSep 1, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT OF A 1MM X 2.5CM GALAXY G3 MINI (GLM910025, L13803) AND DECIDED TO PULL IT OUT. DURING RESHEATHING, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476512 ↗
• MalfunctionAug 21, 2020Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN FELT STRONG RESISTANCE WHILE ADVANCING DISTAL SHEATH OF A 1MM X 2.5CM GALAXY G3 MINI (GLM910025, L14176). NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE DEVICE WAS NOT ABLE TO ¿MOVE¿. A PICTURE WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE DEVICE ANALYSIS OF THE GALAXY G3 MINI 1MM X 2.5CM, THE EMBOLIC COIL WAS FOUND KINKED AND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437059 ↗
• 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 10391452 ↗
• 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 10391398 ↗
• InjuryDec 11, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THAT TARGETED AN UNRUPTURED 5 MM ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH A 3.8MM NECK SIZE, AFTER THE 1.0MM X 2.5CM GALAXY G3 MINI COIL (GLM910025/L12957) WAS DELIVERED VIA THE PHENOM¿ .017 MICROCATHETER (MEDTRONIC) AND SUCCESSFULLY DETACHED AT THE TARGET LESION, THE MICROCATHETER AND THE DELIVERY WIRE HERNIATED FROM THE ANEURYSM AND THE A1 SEGMENT INTO THE M1 SEGMENT UPON THE REMOVAL OF THE DELIVERY WIRE. A LOOP OF THE COIL WAS PULLED BACK INTO THE PARENT ARTERY AND RESULTED IN A THROMBUS FORMATION. INTEGRILIN WAS ADMINISTERED AS AN INTERVENTION TO CLEAR THE CLOT AROUND THE COIL LOOP. IT WAS REPORTED THAT THERE WAS NO TREATMENT FOR THE COIL LOOP THAT WAS PULLED INTO THE PARENT ARTERY. THE VESSEL TORTUOSITY WAS REPORTED TO BE LOW. THE CONCOMITANT PRODUCTS THAT WERE USED IN THE PROCEDURE INCLUDED THE ATLAS¿ STENT (STRYKER), 5X10 HYDROFRAME® HYDROGEL FRAMING COIL (MICROVENTION), AND TWO SPECTRA COILS. THE STENT HAD BEEN IMPLANTED WHEN THE REPORTED EVENT OCCURRED, AND IT REMAINED WELL OPPOSED TO THE VESSEL WALL WITH GOOD NECK COVERAGE. THERE WAS NO EVIDENCE OF DISTAL THROMBUS EMBOLIZATION. THE DELIVERY WIRE WAS

  Patient problems: Thrombosis

  MAUDE report 8153737 ↗
• InjuryNov 9, 2018Separation Failure; Material Protrusion/Extrusion; Separation Problem; Separation Failure; Material Protrusion/Extrusion; Separation Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 1.0MM X 2.5CM GALAXY G3 MINI (GLM910025/UNK LOT) THERMO-MECHANICAL COIL FAILED TO DETACH AND THEN SEPARATED DURING A COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY. THE COMPLIANT COIL WAS CHOSEN AS THE FINISHING COIL AND WAS DELIVERED TO THE TARGET LESION. THE PHYSICIAN PRESSED THE DETACHMENT BUTTON THREE TIMES, BUT THE COIL DID NOT DETACH. THE PHYSICIAN MOVED THE COIL IN AND OUT SEVERAL TIMES AND THE COIL UNINTENTIONALLY SEPARATED IN THE CONCOMITANT SL-10 (STRYKER) MICROCATHETER. THE COIL WAS IMPLANTED WITH THE DELIVERY SYSTEM EVEN THOUGH A LOOP PROTRUDED OUT TO THE MAIN VESSEL. A STENT WAS IMPLANTED TO PRESS THE LOOP AGAINST THE VESSEL WALL. A COMPETITOR COIL WAS IMPLANTED, AND THE LESION¿S VESSEL WALL WAS VERIFIED BY ANGIOGRAPHY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. TRAXCESS14

  Patient problems: No Code Available

  MAUDE report 8057153 ↗

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).