GALAXY G3 GLY120407Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704077497), received between May 31, 2018 and Nov 3, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Kinked” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A NON J&J MICROCATHETER WAS IN PLACE AND A GALAXY G3 4MM X 7CM COIL (GLY120407, 0582529S) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451287 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY (B)(4), A 51-YEAR-OLD FEMALE ((B)(6) WITH A HISTORY OF CONTROLLED HYPERTENSION AND POLYCYSTIC KIDNEY DISEASE UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM IN THE BIFURCATION BRANCH OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) ON (B)(6) 2022. THE PATIENT¿S PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 5.0 MM, DOME 4.7 MM, MAXIMUM ANEURYSM DIAMETER 5.1 MM, NECK SIZE 1.3 MM, AND DOME-TO-NECK RATIO OF 3.6 MM. THE PARENT VESSEL DIAMETER WAS 1.5 MM. COIL EMBOLIZATION WAS PERFORMED WITH FIVE (5) CERENOVUS COILS: A GALAXY G3 4MM X 7CM (GLY120407/30508862), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/K10383), A GALAXY G3 XSFT 2MM X 2CM (GLX120202/30641974), A GALAXY G3 XSFT 2MM X 2CM (GLX120202/30641974) AND A GALAXY G3 XSFT 2MM X 2CM (GLX120202/ 30563817) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. A BALLOON CATHETER (BRAND NOT SPECIFIED) WAS ALSO USED, BUT NOT IMPLANTED. 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 IN THE C

  Patient problems: Aneurysm

  MAUDE report 17281202 ↗
• InjuryDec 14, 2022Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4MM X 7CM GALAXY G3 COIL (GLY120407 / 30727423) FAILED TO DETACH AFTER TEN (10) ATTEMPTS. THE COIL WAS THEN REPORTEDLY PULLED OUT. AT THE END OF THE MICROCATHETER, IT WAS FOUND THAT THE COIL DETACHMENT ZONE WAS BROKEN IN THE MICROCATHETER. THE PHYSICIAN USED A WIRE TO ¿PULL THE COIL OUT OF THE MICROCATHETER.¿ IT WAS REPORTED THAT THE COIL WAS LOST ON THE OPERATING TABLE AND COULD NOT BE FOUND. ¿IT WAS FOUND THAT THE DETACHMENT ZONE OF THE DELIVERY WIRE HAD A CHARRED APPEARANCE.¿ A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES. THE PATIENT WAS STABLE. ON (B)(6) 2022 , THE CERENOVUS SALES REPRESENTATIVE PROVIDED AN UPDATED EVENT DESCRIPTION. THE EVENT REPORTED THAT AT THE 70-YEAR-OLD FEMALE PATIENT PRESENTED WITH DIZZINESS AND LIMB WEAKNESS UNDERWENT AN EXAM WHICH REVEALED AN INTRACRANIAL ANEURYSM. MICROCATHETERS WERE PLACED AT THE TARGET LESION AND THE COMPLAINT COIL WAS PLACED INTO THE ANEURYSM CAVITY ALONG THE MICROCATHETER; IT CONFORMED WELL. DETACHMENT BOX WAS CONNECTED AND THE PHYSICIAN PRESSED THE DETACHMENT BUTTON, THEN WITHDREW THE DELIVERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977955 ↗
• MalfunctionJun 25, 2018Kinked; Stretched; Kinked; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE, THE USER ATTEMPTED TO RE-SHEATH THE 4MM X 7CM GALAXY G3 (GLY120407/S11710) THERMO-MECHANICAL COIL AS IT WAS CONSIDERED THE WRONG SIZE FOR THE LESION, BUT THE TRANSPARENT DEVICE POSITIONING UNIT (DPU) SLEEVE WENT OPEN AND IT WAS NO LONGER POSSIBLE TO RE-ADVANCE THE COIL. THE DEVICE POSITIONING UNIT (DPU) PROTRUDED FROM THE INTRODUCER AND THE DPU WIRE WAS VISIBLE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THERE WAS NO DIFFICULTY ENCOUNTERED UNSHEATHING THE INTRODUCER TUBE FROM THE DELIVERY TUBE OF THE DCS. AN ADEQUATE FLUSH WAS MAINTAINED. THE INTRODUCER WAS NOT DAMAGED IN ANY WAY. NO VISIBLE DAMAGE WAS NOTED TO THE CONCOMITANT SL-10 (STRYKER) MICROCATHETER. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. PRIOR TO THIS COIL, OTHER COILS WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE; HOWEVER, THE EXACT QUANTITY CANNOT BE RECALLED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE. THE USER DID NOT APPLY EXCESSIVE FORCE WHILE UNSHEATHING OR RESHEATHING. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635261 ↗
• MalfunctionMay 31, 2018Kinked; Stretched; Material Integrity Problem; Kinked; Stretched; Material Integrity Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE, THE USER ATTEMPTED TO RE-SHEATH THE 4MM X 7CM GALAXY G3 (GLY120407/S11710) THERMO-MECHANICAL COIL AS IT WAS CONSIDERED THE WRONG SIZE FOR THE LESION, BUT THE TRANSPARENT DEVICE POSITIONING UNIT (DPU) SLEEVE WENT OPEN AND IT WAS NO LONGER POSSIBLE TO RE-ADVANCE THE COIL. A SECOND 4MM X 7CM GALAXY G3 (GLY120407/S11710) WAS SELECTED FOR USE, BUT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT THROUGH THE ROTATING HEMOSTASIS VALVE (RHV). THE USER PULLED THE COIL BACK AND DEPLOYED IT UNDER WATER. THE EMBOLIC COIL WAS VISIBLY DAMAGED AT THE FIRST WINDING. THE PROCEDURE WAS COMPLETED WITH TWO NEW COILS. THE SURGERY WAS DELAYED 10 MINUTES DUE TO THE EVENTS. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCTS WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556202 ↗