GALAXY G3 GLX123505Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704077657), received between Dec 12, 2017 and Jun 8, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 52-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPOTHYROIDISM UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT MIDDLE CEREBRAL ARTERY (MCA) SIDE WALL ANEURYSM ON 15-DEC-2022. THE HUNT & HESS GRADE WAS 3, THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE TARGET ANEURYSM WAS AS FOLLOWS: HEIGHT 4.1MM, DOME 5.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.2MM, AND DOME-TO-NECK RATIO OF 2.3MM. THE PARENT VESSEL DIAMETER WAS 1.7MM. COIL EMBOLIZATION WAS PERFORMED USING THREE (3) CERENOVUS COILS: A 4MM X 7.5CM MICRUSFRAME 10 (MFR100407 / 30686615), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / 30483248), AND A 2MM X 2CM GALAXY G3 XSFT (GLX120202 / 30583817) VIA AN SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS DURING THE INDEX PROCEDURE. ON 05-JAN-20

  Patient problems: Aneurysm

  MAUDE report 17093077 ↗
• MalfunctionJan 26, 2023Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE RIGHT INTERNAL CAROTID ARTERY OF A TOTAL CHOROIDAL ARTERY ANEURYSM, A SHORYU HR BALLOON CATHETER WAS HELD DISTAL OF THE ANEURYSM FOR RESCUE IN THE EVENT OF VASCULAR PERFORATION. A GALAXY G3 XSFT 3.5MM X 5CM COIL (GLX123505, 30517624) WAS INSERTED AS THE SECOND COIL. THE COIL WAS WOUNDED OUTSIDE THE FRAME. THE COMPLAINT COIL WAS RE-SHEATHED BECAUSE THE PHYSICIAN THOUGHT THE SIZE DID NOT FIT. HOWEVER, THE COIL DETACHMENT PART WAS UNRAVELED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE A GUIDEWIRE (SYNCHRO SELECT 0.014" 215CM), A GUIDING CATHETER (FUBUKI HARD 7FR 90CM), AND A MICROCATHETER (EXSELSIOR SL10). ADDITIONAL INFORMATION RECEIVED INDICATED THAT IS IS UNKNOWN IF THE COIL PREMATURELY DETACHED. THERE WAS NO EXCESSIVE FORCE USED AT ANY TIME WITH THE DEVICE. NO RESISTANCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246811 ↗
• MalfunctionMay 16, 2022Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, THE PATIENT UNDERWENT A CEREBRAL COIL EMBOLIZATION PROCEDURE OF THE INTERNAL CAROTID ARTERY (ICA). DURING THE PROCEDURE, THE DELIVERY WIRE OF THE GALAXY G3 XSFT 3.5MM X 5CM (GLX123505, 30517624) WAS USED, BUT IT WAS TOO STIFF TO MOVE THE SLEEVE AND IT WAS UNABLE TO BE PEELED AWAY. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. A CONTINUOUS FLUSH WAS DONE DURING THE PROCEDURE. THE DEVICE WAS USED WITH A MICROCATHETER EXCELSIOR SL-10 (STRYKER NEUROVASCULAR). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PEEL-AWAY SHEATH NEAR THE SLEEVE PORTION OF THE COMPLAINT COIL IS DAMAGED AS A RESULT OF THE SLEEVE BEING TOO STIFF TO PEEL-AWAY. THE ISSUE OCCURRED PRIOR TO USE THE DEVICE IN THE PATIENT, THEREFORE THERE WAS NO PATIENT IMPACT. IT WAS CONFIRMED AFTER IT WAS TAKEN OUT FROM THE POUCH, THEREFORE, NO RESISTANCE WAS REPORTED BETWEEN THE MICROCATHETER AND THE COMPLAINT DEVICE. BASED ON THE DEVICE ANALYSIS OF THE PRODUCT RECEIVED, THE EMBOLIC COIL WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407030 ↗
• 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 8696227 ↗
• MalfunctionDec 12, 2017Difficult To Position; Material Protrusion/Extrusion; Difficult To Position; Material Protrusion/Extrusion

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING LEFT PERICALLOSAL COIL EMBOLIZATION, THREE GALAXY G2 COILS (GLY120615 / S11513, GLX120408/ S12259, GLX123505/ S11634) WERE ADVANCED INTO THE ANEURYSM UNTIL THERE WAS APPROXIMATELY 1-1.5CM LEFT OF THE LENGTH TO INSERT INTO ANEURYSM. AT THIS POINT, EACH OF THESE COILS FAILED TO BREAK AND REMAINED STRAIGHT RESULTING IN PROTRUSION BACK INTO THE PHENOM 17 WITH 45-DEGREE TIP MICROCATHETER AND MICROCATHETER PUSH-BACK. IN ADDITION, THE FIRST COIL (GLY120615 / S11513) STRETCHED. THE PHYSICIAN RETRACTED AND RE-ATTEMPTED EACH COIL MULTIPLE TIMES WHICH HAD THE SAME RESULT EACH TIME OF FAILURE TO BREAK AT THE 1-1.5CM POINT. EACH COIL WAS REMOVED FROM THE PATIENT AND WAS DISCARDED. THE MICROCATHETER DID NOT APPEAR DAMAGED AND DEVICES HAD BEEN PREPPED AND USED AS PER THE IFU. THERE WAS NOT PATIENT INJURY AND THE EVENT DELAYED THE PROCEDURE 10 MINUTES. INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT AND MEDICAL HISTORY WERE NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7109867 ↗