GALAXY G3 GLY122505Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704077411), received between Dec 17, 2019 and Jan 31, 2024 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN UNSPECIFIED MICROCATHETER (MC) WAS IN PLACE AND A GALAXY G3 2.5MM X 5CM COIL (GLY122505, 30757518) WAS DELIVERED TO TARGET SITE. THE COIL 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. DOCTOR PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH. THEN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-JAN-2024 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DCB AND CABLE WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL WAS NOT STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617561 ↗
• MalfunctionSep 23, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 2.5MM X 5CM GALAXY G3 (GLY122505 / 30747569) FAILED TO DETACH. IT WAS REPORTED THAT OTHER COILS WERE USED BEFORE THIS COIL AND AFTER THIS COIL WITHOUT ANY PROBLEM. THE PROCEDURE WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804844 ↗
• MalfunctionJan 4, 2023Entrapment of Device; Deformation Due to Compressive Stress; Migration; Entrapment of Device; Deformation Due to Compressive Stress; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 47-YEAR-OLD FEMALE PATIENT UNDERWENT A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING A 3.5MM BASILAR ARTERY (BA) ANEURYSM, A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3074237323) WAS DEPLOYED VIA A PROWLER SELECT PLUS MICROCATHETER AND PLACED AT THE IDEAL POSITION ON THE FIRST ATTEMPT. AFTER THAT, AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS DELIVERED TO THE LESION. THE MICROCATHETER WAS SET EXACTLY AT THE MIDDLE OF FOUR MARKERS ON THE PULSERIDER LEAFLET. TWO COIL EMBOLIZATION VIA THE TRANSCELL TECHNIQUE WERE PERFORMED WITHOUT ANY ISSUES. A 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / LOT# UNKNOWN) AND A 2.5MM X 5CM GALAXY G3 (GLY122505 / LOT# UNKNOWN) WERE IMPLANTED. WHEN THE THIRD COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / LOT# UNKNOWN) WAS INSERTED, IT WAS REPORTED THAT THE COIL PENETRATED THE RIGHT UPPER PART OF THE ANEURYSM WHICH RESULTED IN BLEEDING. THIS THIRD COIL WAS DESCRIED AS ¿WOUND OUTSIDE THE ANEURYSM AS IT WAS, AND THE COIL WAS LEFT FOR A WHILE.¿ ANGIOGRAPHY WAS TAKEN AGAIN AFTER A WHILE AND IT WAS CONFIRMED THAT THE BLEEDING HAD STOPPED. AFTER THAT, IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097053 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE (B)(6)- YEAR-OLD FEMALE PATIENT WITH A HISTORY OF DIABETES, UNCONTROLLED HYPERTENSION, UNCONTROLLED HYPERLIPIDEMIA, HEADACHES, MIGRAINES, SLEEP APNEA, TUBAL LIGATION, ROSACEA, FATTY LIVER, HERPES ZOSTER, BENIGN PAROXYSMAL VERTIGO, AND CLASS 2 OBESITY (BMI 37 KG/M2) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED RIGHT MCA BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSION: HEIGHT 4.9MM, DOME 5.2MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO 1.6MM. THE PARENT VESSEL DIAMETER WAS 1.5MM. THE PATIENT UNDERWENT COIL EMBOLIZATION WITH THE IMPLANTATION OF ONE 4MM X 11.5CM MICRUSFRAME 10 COIL (MFR100412 / L10083), ONE 3MM X 6CM GALAXY G3 COIL (GLY120306 / L12402), ONE 2.5MM X 5CM GALAXY G3 COIL (GLY122505 / L11547), ONE 1.5MM X 4CM DELTAFILL 10 COIL (DLF100154 / UNKNOWN LOT NUMBER), AND ONE 1.5MM X 1CM DELTAXSFT 10 COIL (DLXA100151 / UNKNOWN LOT NUMBER) VIA A HEADWAY DUO MICROCATHETER (MICROVENTION) MICROCATHETER. A NEURO-FORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED FOR NECK REMODELING. HEP

  Patient problems: Infarction, Cerebral; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10824558 ↗
• DeathOct 14, 2020Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, TWO COILS (A 2.5MM X 5CM GALAXY G3 COIL: GLY122505 / L13317 AND A 1.5MM X 2CM DELTAXSFT 10 COIL: DLX100152 / K10051) BECAME DISLODGED FROM THE ANEURYSM DURING THE PROCEDURE AND MIGRATED INTO OTHER VASCULAR TERRITORIES. THE PATIENT HAD SINCE EXPIRED BUT IT IS UNKNOWN IF THIS INCIDENT CAUSED OR CONTRIBUTED TO THE FATAL OUTCOME.

  Patient problems: Death; Intracranial Hemorrhage; Stroke/CVA

  MAUDE report 10678927 ↗
• MalfunctionDec 17, 2019Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, RESISTANCE WAS FELT WHILE INTRODUCING A 2.5MM X 5CM GALAXY G3 COIL (GLY122505, L11860) INTO AN ECHELON MICROCATHETER (MC). THE RESISTANCE WAS FELT JUST BEFORE THE FLUORO MARKERS WENT INSIDE THE MICROCATHETER. THE DEVICE WAS REMOVED THROUGH THE MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SET. THE PROCEDURE WAS NOTED TO BEING AS ¿USUAL¿. EVERYTHING WAS DONE PROPERLY BUT WHEN THE COIL REACHED THE DISTAL PART OF THE MICROCATHETER (KIND OF THE MOMENT WHEN THREE MARKERS WERE INSERTED INTO THE Y-CONNECTOR) IT GAVE THE FEELING OF RESISTANCE. IT WAS HARD TO PUSH THE COIL, THE FEELING WAS AS IF THE MICROCATHETER WAS NARROWING AND THE COIL WOULDN¿T HAVE HAD ENOUGH SPACE TO GO THROUGH. IT WAS STUCK BUT POSSIBLE TO REMOVE AFTER SOME MOVEMENTS. THE 2.5MM X 5CM GALAXY G3 COIL WAS NOT KINKED. THE COIL OR DELIVERY SYSTEM WAS DAMAGED DUE TO THE RESISTANCE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO AND AFTER THE ENCOUNTERED RESISTANCE. NEITHER THE DEVICE OR MICROCATHETER KINKED OR BENT PRIOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481703 ↗