GALAXY G3 GLX122525Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704077602), received between Jul 16, 2019 and Nov 14, 2022 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2022Material Rupture; Stretched; Material Rupture; Stretched

  IT WAS REPORTED FROM A PERSONAL INTERACTION THAT DURING A COIL EMBOLIZATION OF A CEREBRAL ANEURYSM IN THE SUPERIOR CEREBELLAR ARTERY (SCA), A GALAXY G3 XSFT 2.5MM X 2.5CM COIL (GLX122525/UKNOWN LOT) WAS SELECTED FOR USE AS THE 2ND COIL. IT WAS MENTIONED THAT ¿IN THE Y CONNECTOR, BEFORE PLACING THE COMPLAINT COIL SHEATH ON THE CATHETER ENTRANCE¿, THE ASSISTANT PHYSICIAN ¿PULLED OUT THE COMPLAINT COIL AND WHEN PULLING THE COMPLAINT COIL BACK, THE SHEATH WAS PULLED OUT FROM THE Y CONNECTOR WITH THE COMPLAINT COIL COMING OUT FROM THE SHEATH.¿ AT THIS TIME, A FORCE TO PULL OUT THE COMPLAINT COIL WAS APPLIED, AND THE COMPLAINT COIL BECAME UNRAVELED. ¿AFTER THAT, THERE WAS 7 OR 8 CM BETWEEN THE COIL TIP ADVANCING IN THE CATHETER AND THE MARKER¿, WHICH WAS INTERPRETED AS THE COIL BEING STRETCHED. IT WAS STATED THAT ¿AT THE TIME OF CUTTING, THE UNRELEASED COIL WAS MISTAKENLY RECOGNIZED AS A MARKER AND THE COMPLAINT COIL WAS CUT¿. THE CUT COMPLAINT COIL WAS THEN ABLE TO BE REMOVED BY A SNARE DEVICE (UNKNOWN DEVICE DETAILS) AND OTHER COILS (UNKNOWN DEVICE DETAILS) WERE USED FOR COMPLETING THE EMBOLIZATION. THERE WAS NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT CONTINUOUS FLUSH WAS NOT DO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787833 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 42-YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH NO TARGETED MEDICAL HISTORY, EXCEPT BEING A SMOKER, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT ANEURYSM IN THE BIFURCATION OF THE INTERNAL CAROTID ARTERY ON (B)(6) 2021. THE PATIENT¿S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED ON (B)(6) 2021, THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 5.1MM, DOME 6.3MM, MAXIMUM ANEURYSM DIAMETER 6.3MM, NECK SIZE 1.9MM, AND THE DOME-TO-NECK RATIO OF 3.3MM. THE PARENT VESSEL DIAMETER WAS NOT DONE. THE FOLLOWING COILS WERE IMPLANTED VIA AN ECHELON 10 MICROCATHETER (MEDTRONIC): ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/ 30532733), ONE 4MM X 12CM GALAXY G3 (GLY120412/30541491), ONE 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535/30546472), ONE 2MM X 4MM GALAXY G3 MINI (GLM920040/30558132), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/30558365), AND ONE 2MM X 2MM GALAXY G3 XSFT (GLX120202/L16466). ONE 2.5MM X 2.5CM GALAXY G3 XSFT (GLX122525/30541484) WAS USED, BUT NOT IMPLANTED. MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED A TOTAL OF THREE TIMES. HEPARIN WAS ADMIN

  Patient problems: Ruptured Aneurysm

  MAUDE report 14516741 ↗
• MalfunctionMay 23, 2022Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A RENAL ARTERY ANEURYSM, A 2.5MM X 2.5CM GALAXY G3 COIL (GLX122525, 30393415) WAS DELIVERED FROM A CONCOMITANT MICROCATHETER (VELOUTE, ASAHI INTECC). HOWEVER; THE DEVICE BECAME STUCK IN THE MICROCATHETER WHEN IT WAS BEING DELIVERED. WHEN THE PHYSICIAN PUSHED AND PULLED THE COMPLAINT PRODUCT IN THE MICROCATHETER, THE COIL WAS DETACHED IN THE MICROCATHETER. THE COMPLAINT PRODUCT AND THE MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT'S BODY. AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM WITH USING COMPETITIVE COILS. THERE WAS NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469329 ↗
• MalfunctionNov 3, 2020Unraveled Material; Unraveled Material

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, OF THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC). COIL EMBOLIZATION STARTED WITH A NEUROFORM ATLAS STENT, STRYKER BY PERFORMING JAIL TECHNIQUE. A 4MM X 8CM G3 XSFT COIL WAS USED AS THE FIRST COIL. A 2.5MM X 2.5CM GALAXY G3 XSFT (GLX122525, L13191) WAS USED AS A SECOND COIL, BUT THERE WAS AN INTENSIVE RESISTANCE FELT WITH A SL10 MICROCATHETER, STRYKER. THE COMPLAINT COIL WAS REMOVED, AND THE PHYSICIAN CONFIRMED THAT THE COMPLAINT COIL GOT UNRAVELED. A 2.5MM X 2.5CM GALAXY G3 XSFT (GLX122525, L13190) WAS USED AS THE THIRD COIL ,BUT THE SAME ISSUE OCCURRED AGAIN. THEY WERE REPLACED WITH ANOTHER TWO COMPETITIVE PRODUCTS, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778475 ↗
• MalfunctionNov 3, 2020Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, OF THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC). COIL EMBOLIZATION STARTED WITH A NEUROFORM ATLAS STENT, STRYKER BY PERFORMING JAIL TECHNIQUE. A 4MM X 8CM G3 XSFT COIL WAS USED AS THE FIRST COIL. A 2.5MM X 2.5CM GALAXY G3 XSFT (GLX122525, L13191) WAS USED AS A SECOND COIL, BUT THERE WAS AN INTENSIVE RESISTANCE FELT WITH A SL10 MICROCATHETER, STRYKER. THE COMPLAINT COIL WAS REMOVED, AND THE PHYSICIAN CONFIRMED THAT THE COMPLAINT COIL GOT UNRAVELED. A 2.5MM X 2.5CM GALAXY G3 XSFT (GLX122525, L13190) WAS USED AS THE THIRD COIL, BUT THE SAME ISSUE OCCURRED AGAIN. THEY WERE REPLACED WITH ANOTHER TWO COMPETITIVE PRODUCTS, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778468 ↗
• MalfunctionAug 31, 2020Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION TARGETING AN UNRUPTURED ANEURYSM, THREE G3 COILS WERE USED. THE 2.5MM X 2.5CM GALAXY G3 XSFT COIL (GLX122525 / L13191) WAS THE FOURTH COIL CHOSEN TO BE USED, BUT IT UNRAVELED. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE COIL WAS NOT DETACHED. THERE WAS NO BLOOD FLOW RESTRICTION OR REDUCTION AS A RESULT OF THE ISSUE REPORTED. THE EVENT DID NOT CAUSE ANY CLINICALLY SIGNIFICANT DELAY. THERE IS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10473411 ↗
• MalfunctionJul 16, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM, THE 2.5MM X 2.5CM GALAXY G3 XSFT COIL (GLX122525 / L13191) WAS THE THIRD COIL CHOSEN; THE COIL WAS INSERTED INTO THE TARGET LESION WITHOUT CHECKING THE ELECTRICAL CONNECTION WITH THE ENPOWER CONTROL CABLE (ECB00018200 / L15229). THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE LIGHT DID NOT ILLUMINATE ON THE CONTROL CABLE AND THE DETACHMENT COULD NOT BE PERFORMED. THE 2.5MM X 2.5CM GALAXY G3 XSFT COIL WAS REPLACED WITH ANOTHER GALAXY G3 XSFT OF A DIFFERENT SIZE AND IT WAS IMPLANTED IN THE TARGET LESION. THE PROCEDURE WAS COMPLETED; THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION, NO PROCEDURAL DELAY. PRELIMINARY PHOTO IMAGES OF THE COMPLAINT DEVICE WERE CAPTURED BY THE J&J (B)(4) AFFILIATES. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS; EVALUATION AND TESTING WILL BE PERFORMED WHEN THE PRODUCT IS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795327 ↗