GALAXY G3 GLM925055Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704080282), received between Mar 13, 2018 and Jan 29, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A NON J&J MICROCATHETER (MC) WAS IN PLACE AND A GALAXY G3 MINI 2.5MM X 5.5CM COIL (GLM925055, 30824771) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR INSPECTED INDICATOR LIGHT OF THE DETACHMENT CONTROL BOX (DCB) AND CONNECT CABLE, AND OBSERVED ALL WERE UNDER GOOD CONDITION. THE DOCTOR PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH. THEN THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A SECOND NEW COIL TO FILL THE ANEURYSM AND BE DETACHED SUCCESSFULLY. LATER THE THIRD COIL, A GALAXY G3 MINI 3MM X 6CM (GLM930060, 30889366) HAD THE SAME ISSUE WHEN IT WAS TO BE DETACHED, THE DOCTOR ONLY RETRACTED THE THIRD COIL ALONE AND SWITCHED TO A FOURTH NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-JAN-2025 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CONTROL CABLE WERE SUCCESSFULLY WITH SUBSEQUENT COILS. THE COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264507 ↗
• MalfunctionAug 7, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND) WAS IN PLACE AND THREE COILS WERE USED TO FILL THE ANEURYSM, THEN THE FOURTH COIL, A 2.5MM X 5.5CM GALAXY G3 MINI (GLM925055 / 30803121) WAS USED, IT WAS IMPEDED IN THE PROXIMAL END OF THE MICROCATHETER AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 16-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET VESSEL WAS THE LEFT INTERNAL CAROTID ARTERY (ICA). NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE ISSUE RELATED TO THE COIL BECOMING IMPEDED ¿OCCURRED DURING IMPORT.¿ A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE INTRODUCER TIP WAS FIRMLY INSTALLED INTO THE MICROCATHETER HUB AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE ADVANCEMENT OF THE DEVICE. PER THE INFORMATION, THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933285 ↗
• MalfunctionDec 28, 2021Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THE COMPLAINT COIL, A 2.50MM X 5.50CM GALAXY G3 MINI (GLM925055 / 30383055) BECAME STUCK IN THE HUB OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). IT WAS REPORTED THAT THE ¿COIL IS BROKEN.¿ THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13102057 ↗
• MalfunctionSep 30, 2021Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 2.50MM X 5.50CM GALAXY G3 MINI COIL (GLM925055 / 30379816) BECAME STRETCHED DURING INSERTION THROUGH THE PHENOM¿ MICROCATHETER (MEDTRONIC). THE COIL WAS RETRACTED AND REPLACED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558344 ↗
• InjuryAug 2, 2021Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF AN ARTERIOVENOUS FISTULA (AVF), A 2.5MM X 5.5CM GALAXY G3 MINI (GLM925055/K10172) COIL WAS PREMATURELY DETACHED INSIDE THE CONCOMITANT MICROCATHETER (SIZE/BRAND NOT SPECIFIED). THE PHYSICIAN REPOSITIONED THE MICROCATHETER PRIOR TO ADVANCING THE COIL INTO THE AVF AND BELIEVES THAT THIS MANEUVER MAY HAVE CAUSED THE COIL TO UNINTENDEDLY DETACH. IT WAS REPORTED THAT THERE WAS NO UNUSUAL UNSHEATHING OF COIL. AS THE PHYSICIAN PUSHED THE DELIVERY WIRE FORWARD, RESISTANCE WAS NOTICED AND REALIZED THE COIL HAD DETACHED. THE PHYSICIAN THEN ATTEMPTED TO USE A MICROWIRE TO ADVANCE THE PREMATURELY DETACHED COIL THROUGH THE MICROCATHETER, BUT HE WAS UNABLE TO PUSH THE COIL FORWARD WITH THAT TECHNIQUE. THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT AND THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THAT POINT. IT WAS REPORTED THAT THERE WAS NO NEGATIVE PATIENT OUTCOME AND NO SIGNIFICANT DELAY IN THE TREATMENT OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 28-JUL-2021 INDICATED THAT THE TARGET AVF WAS LOCATED AT THE DISTAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN FELT THAT THE AVF WAS ADEQUATELY TREATED. THIS COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12260717 ↗
• InjuryMar 25, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2019, DURING THE PLANNED COIL EMBOLIZATION THAT WAS TARGETING A RUPTURED TRI-LOBED SHAPE ANEURYSM APPROXIMATELY 2.5 MM IN DIAMETER ON THE LEFT POSTERIOR COMMUNICATING (PCOM) ARTERY. THE TRI-LOBED ANEURYSM HAD THE FOLLOWING DIMENSIONS: 4 MM HEIGHT (CRANIO-CAUDAL), 5 MM LENGTH, AND A 2 MM NECK. THE PHYSICIAN SELECTED A 2.5MM X 5.5CM GALAXY G3 MINI COIL (GLM925055 / L13445) TO BE THE FIRST COIL. IT WAS REPORTED THAT ACCESS TO THE ANEURYSM WAS SLIGHTLY CHALLENGING DUE TO TORTUOSITY IN THE PROXIMAL VESSELS, BUT THE ANEURYSM WAS ITSELF CATHETERIZED RELATIVELY EASILY. THE ANEURYSM RUPTURED FOLLOWING THE PLACEMENT OF THE COIL. A RUN IMMEDIATELY AFTER THE ANEURYSM CATHETERIZATION DID NOT SHOW ANY ISSUES OR BLEEDING. THE COIL WAS THEN DEPLOYED, AND ALTHOUGH THERE WAS A SLIGHT CHALLENGE IN FEEDING THE LAST SECTION OF THE COIL (WITH THE COIL BEING PULLED BACK SLIGHTLY AND THEN ADVANCED AGAIN TO HELP STABILIZE THE MICROCATHETER TIP POSITION ¿ WITH THE EXCELSIOR®SL-10® MICROCATHETER (STRYKER) ALSO BEING ADVANCED FORWARD SLIGHTLY), IT THEN SEEMED TO SIT WELL WITHIN THE ANEURYSM. THERE WAS NO DAMAGE OBSERVED ON THE COIL. THE MICROCATHETER WAS NOT

  Patient problems: Aneurysm; Infarction, Cerebral; Rupture; Vasoconstriction

  MAUDE report 8449519 ↗
• MalfunctionMar 13, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO A 4MM ANEURYSM OF THE POSTERIOR COMMUNICATING ARTERY (PCON), ONCE AN ORBIT GALAXY G3 MINI MICROCOIL ((B)(4)) WAS DETACHED, A TAIL FELL INTO THE PARENT VESSEL. THERE WAS NO PATIENT INJURY REPORTED. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. NO ADDITIONAL INTERVENTION WAS PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS IMPLANTED. THE DEVICE WAS STORED, INSPECTED AND PREPPED PER INSTRUCTIONS FOR USE (IFU). NO ANOMALIES WERE NOTED PRIOR TO USE. NO EXCESSIVE FORCE WAS USED AT ANY TIME DURING THE USE OF THE DEVICE. THERE WERE NO DIFFICULTIES DETACHING THE DEVICE. THERE WERE NO ATTEMPTS TO REMOVE COIL. THE COIL WAS NOT FIXED TO THE VESSEL WALL BY STENT, OBSTRUCTION OF FLOW, THROMBOSIS. NO STENT WAS NOT USED. THE ORBIT GALAXY WAS THE FIRST AND ONLY COIL USED IN THIS PROCEDURE. THE MICROCATHETER WAS SEEDED 1/3 OF THE WAY IN THE ANEURYSM AT THE TIME OF DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7336221 ↗

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).