GALAXY G3 GLY123575Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704077435), received between Oct 5, 2017 and Mar 28, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionMar 28, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE CEREBRAL ANEURYSM. A GALAXY G3 3.5MM X 7.5CM COIL (GLY123575, 30508877) WAS CONNECTED TO AN ENPOWER CONTROL CABLE (ECB00018200, 30960241). BUT, THE INDICATOR LED OF CDB2 DID NOT ILLUMINATE. THE CABLE WAS REPLACED WITH ANOTHER CABLE, BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE INDICATOR LED WAS ILLUMINATED. THE COMPLAINT COIL WAS DELIVERED, AND THE DETACHMENT CYCLE WAS PERFORMED. THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS THE INTERNAL CAROTID ARTERY. OTHER CONCOMITANT DEVICE IS A MICROCATHETER (HEADWAY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626604 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A 58-YEAR-OLD FEMALE UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF A RECURRENT RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM AND EXPERIENCED INTRAOPERATIVE THROMBUS FORMATION AT THE ANEURYSM NECK. THE THROMBUS WAS NOTED TO BE PROTRUDING INTO THE PARENT VESSEL. USING A SCEPTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON (MICROVENTION), THE COIL MASS WAS PUSHED UP TO THE ANEURYSM SIDE, AND THE DELIVERY TO THE ANEURYSM NECK WAS IMPROVED. THE THROMBUS ALSO DECREASED, AND BLOOD FLOW IMPROVED, SO ANTIPLATELET DRUGS WERE PRESCRIBED. THE PATIENT'S CLINICAL COURSE WAS MONITORED. POST-PROCEDURE, THERE WERE NO REMARKABLE FINDINGS. IT WAS LAST REPORTED THAT THE PATIENT IS HOSPITALIZED. THE ATTENDING PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THIS EVENT AND THE PULSERIDER ANRD IS AS FOLLOWS: ¿IT WOULD HAVE BEEN BETTER IF PULSERIDER HAD BEEN PUSHED MORE FIRMLY INTO THE MOTHER'S VEIN; BECAUSE IT WAS SLIGHTLY SWEET, THE COIL WAS CLOGGED UP TO THE VERY END OF THE ANEURYSM NECK, AND AS A RESULT, PULSERIDER DOWN IN THE MOTHER'S VEIN. COMPARED TO THE STENT, THE COIL OF PULSERIDER WAS INSERTED MORE AND

  Patient problems: Thromboembolism

  MAUDE report 14048402 ↗
• MalfunctionJun 23, 2021Difficult to Advance; Difficult to Advance

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, THE (B)(6) YEAR-OLD FEMALE WITH A PAST MEDICAL HISTORY OF HEADACHES UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) BIFURCATION ANEURYSM ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN ANTERIOR CIRCULATION ANEURYSM IN THE LEFT ICA. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 4.0MM, DOME 3.5MM, MAXIMUM ANEURYSM DIAMETER 4.0MM, NECK SIZE 2.4MM, AND DOME-TO-NECK RATIO 1.5MM. THE PARENT VESSEL DIAMETER WAS 2.9MM. THE NEUROFORM ATLAS® STENT SYSTEM (STRYKER) STENT-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30470347), TWO 2MM X 3CM GALAXY G3 MINI (GLM920030 / 30407098 & 30401363), AND ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / 30366403). A PHENOM¿ 17 MICROCATHETER (MEDTRONIC). PER THE INFORMATION DOCUMENTED IN THE CASE REPORT FORM (CRF), MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED ONCE DURING THE PROCEDURE. ADDITIONALLY, ONE 3.5MM X 7.5CM GALAXY G3 (GLY123575 / L17137) AND ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020 / 30392244) WERE USED BUT NOT IMPLANTED. HEPARIN WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051329 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, IT WAS REPORTED VIA THE STERLING STUDY THAT THE (B)(6) FEMALE PATIENT EXPERIENCED ¿TINY STROKES.¿ THE PATIENT IS A CURRENT SMOKER WITH A HISTORY OF DIABETES, HEADACHES, HYPERLIPEMIA, AND HYPERTENSION PRESENTED WITH A RUPTURED MIDLINE, BIFURCATION ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH) ON (B)(6) 2019. THE ANEURYSM WAS 6.8 MM IN HEIGHT WITH A 3.8 MM DOME, MAXIMUM NECK SIZE WAS 6.8 MM, AND A NECK SIZE OF 5.1 MM. THE DOME TO NECK RATIO WAS 0.7 MM AND THE PARENT VESSEL WAS 2.1 MM IN DIAMETER. THE PATIENT¿S PRE-PROCEDURE MRS SCORE WAS 2 AND HUNT & HESS GRADE WAS 2. PRE-PROCEDURE SYMPTOMS INCLUDED HEADACHE WITH PHOTOPHOBIA AND DROWSINESS. TREATMENT WAS PERFORMED ON (B)(6) 2019, WITH THE SUCCESSFULLY IMPLANTATION OF THE FOLLOWING COILS USING THE NEURON¿ MICROCATHETER (PENUMBRA) IN THE FOLLOWING ORDER: 2 MM X 4 CM GALAXY G3 MINI (GLM920040 / L13705), 3 MM X 8 CM GALAXY G3 XSFT (GLX120308 / L12913), 2 MM X 4 CM GALAXY G3 MINI (GLM920040 / L12027), 3 MM X 8 CM GALAXY G3 XSFT (GLX120308 / L11777) AND 3.5 MM X 7.5 CM GALAXY G3 (GLY123575 / L12491). THERE WAS NO MICROCATHETER KICKBACK AND NO INTRA-OPERATIVE THROMBOEMBOLIC EVENTS. PACKING DENSITY

  Patient problems: Infarction, Cerebral

  MAUDE report 8283057 ↗
• MalfunctionOct 5, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING TREATMENT OF A SMALL, MALFORMED ANEURYSM, A GALAXY G3 (GLY123575/S11528) STRETCHED DURING REPOSITIONING OF THE COIL IN THE ANEURYSM. THE EVENT OCCURRED WHEN THE ANEURYSM WAS 29% FILLED. IT WAS REPORTED THAT THE FILLING WAS SUCCESSFUL BECAUSE THE ANEURYSM WAS SMALL AND MALFORMED. THE COIL WAS REMOVED STILL ATTACHED TO THE DPU. NECK REMODELING HAD BEEN PERFORMED WITH A DUO ECLIPSE BALLOON. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. ANOTHER COIL HAD PASSED THROUGH THE SAME MICROCATHETER PRIOR TO THIS EVENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED WITH OTHER SPECTRA COILS. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6915827 ↗