GALAXY G3 GLY120815Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704077572), received between Jun 8, 2023 and Dec 4, 2023 — classified as 1 injury, 1 malfunction.

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

• MalfunctionDec 4, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 8MM X 15CM COIL (GLY120815, 30583809) PASSED THROUGH AN UNSPECIFIED MICROCATHETER TIP. THE PHYSICIAN TRIED TO FILL THE COIL IN THE ANEURYSM, BUT THE COIL WAS IMPEDED IN THE MICROCATHETER TIP AND COULD NOT ADVANCE ANY MORE. THE DOCTOR RETRACTED THE COIL AND OBSERVED THE COIL WAS UNRAVELED/STRETCHED, THEN SWITCHED TO A NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255963 ↗
• 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 / (B)(6)), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / (B)(6)), AND A 2MM X 2CM GALAXY G3 XSFT (GLX120202 / (B)(6)) 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) 2023, TH

  Patient problems: Aneurysm

  MAUDE report 17092997 ↗