GALAXY G3 GLY120715Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704077558), received between Apr 5, 2018 and Jun 8, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 3 most recent of 3 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 (B)(6) 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 (B)(6) 20

  Patient problems: Aneurysm

  MAUDE report 17093004 ↗
• InjuryJun 14, 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

  AS REPORTED BY THE STERLING STUDY, A 64-YEAR-OLD FEMALE PATIENT (SUBJECT (B)(6)) WITH A HISTORY OF DIABETES, CONTROLLED HYPERTENSION, BEING A PREVIOUS SMOKER, DEPRESSION, HEPATITIS C, AND CHRONIC BACK PAIN, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) SACCULAR ANEURYSM WITH MODIFIED RANKIN SCALE (MRS) SCORE 2 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 11.5MM, DOME 9.8MM, MAXIMUM ANEURYSM DIAMETER 10.8MM, NECK SIZE 7.1MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.5MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/ L16383), A GALAXY G3 6MM X 10CM (GLY120610/L13911), A GALAXY G3 6MM X 15CM (GLY120615/K10645), A GALAXY G3 6MM X 20CM (GLY120620/L14866), A GALAXY G3 8MM X 24CM (GLY120824/30530863), GALAXY G3 7MM X 15CM (GLY120715/L15636), GALAXY G3 9MM X 25CM (GLY120925/L13514), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/304943930, A GALAXY G3 XSFT 3MM X 4CM (GLX120304/30370440), AND A 2.5MM X 4MM GALAXY G3 XTRASOFT (30371932). THREE (3) NON- CERENOVUS COILS WERE USED: TWO TARGET 360 ULTRA AND ONE TARGET 360 NANO (ALL STRYKER). A NEUROFORM ATLAS

  Patient problems: Aneurysm

  MAUDE report 14687278 ↗
• MalfunctionApr 5, 2018Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A TERMINAL WIDE NECK (APPROXIMATELY 12 MM WIDE) ANEURYSM ON THE BASILAR BIFURCATION THAT BEGAN WITH Y STENTING USING TWO ENTERPRISE STENT FOLLOWED BY THE PLACEMENT OF SIX SPECTRA COILS; THE SIXTH COIL, THE GALAXY G3 7 MM X 15 CM (GLY120715 / L10379) DID NOT DETACH AFTER THE PHYSICIAN MADE FOUR ATTEMPTS TO DETACH IT. THE COIL WAS REMOVED AND DURING REMOVAL, IT DETACHED IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED WITH THE COIL TO ENSURE NO MAJOR COMPLICATIONS TO THE PATIENT. IT WAS CONFIRMED THAT THE EVENT DID NOT RESULT IN ANY INTERRUPTION OF BLOOD FLOW. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED; THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS BEING RETRACTED INTO THE MICROCATHETER BUT BECAME DETACHED FROM THE DELIVERY SYSTEM WHEN THE COIL DETACHED IN THE MICROCATHETER. THE SAME DETACHMENT CONTROL BOX (DCB2000500 / C50934) AND CONNECTING CABLE (CCB00015700) WERE USED TO DETACH THE SUBSEQUENT COILS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS WITH OTHER BRANDS OF COILS, A TOTAL OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7401576 ↗