GALAXY G3 GLY120202Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704077428), received between Jan 27, 2021 and Feb 20, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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.

• MalfunctionFeb 20, 2026Separation Failure

  DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401600 / 9540635) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). THE PHYSICIAN RETRACTED ONLY THE STENT AND REPLACED IT TO CONTINUE THE PROCEDURE. ANOTHER MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND A 2MM X 2CM GALAXY G3 (GLY120202 / 1042546S) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM AND WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH NEW COILS, A SECOND AND THIRD COIL SUCCESSIVELY, BOTH WERE 1.00MM X 1.00CM GALAXY G3 MINI (GLM910010) FROM THE SAME LOT (1112512S). IT WAS REPORTED THAT BOTH OF THESE COILS WERE ALSO UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE SECOND COIL AND THE THIRD COIL IN SUCCESSION AND REPLACED IT WITH ANOTHER COIL FROM A DIFFERENT MANUFACTURE AND COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE PROCEDURE WAS REPORTEDLY PROLONGED BY ABOUT 10 MINUTES. ON 12-FEB-2026, ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403203 ↗
• MalfunctionJul 14, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN PUT THE MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) IN PLACE AND THE FIRST COIL, A 3MM X 6CM GALAXY G3 (GLY120306 / 3542402S) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED IN THE ANEURYSM AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER FROM THE PATIENT AND REPLACED THE COIL WITH A 2MM X 2CM GALAXY G3 (GLY120202 / 0512508S) TO BE DELIVERED WITH THE SAME MICROCATHETER AND THE SECOND COIL HAD THE SAME ISSUE. THE PHYSICIAN REMOVED THE SECOND COIL AND THE MICROCATHETER FROM THE PATIENT AND REPLACED IT WITH A THIRD COIL AND SECOND MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) TO COMPLETE THE PROCEDURE, WHICH WAS PROLONGED BY APPROXIMATELY 10 MINUTES. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503261 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT PCA ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.1MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 5.1MM, NECK SIZE 2.0MM, AND DOME-TO-NECK RATIO 1.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406/L16293), ONE 2MM X 2CM GALAXY G3 (GLY120202/L12097), ONE 3MM X 8CM GALAXY G3 MINI (GLM930080/L12616), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L11355), AND ONE 1MM X 1CM GALAXY G3 MINI (GLM910010/L14466) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 24.09% ANGIOSUITE PACKING DENSITY. ACCORDING TO THE CASE REPORT FORM (CRF), THERE WAS NO REPORTED MICROCATHETER KICKBACK. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH MODIFIED RAYMOND-ROY SCORE OF CLASS I: COMPLETE =

  Patient problems: Aneurysm

  MAUDE report 11237031 ↗