GALAXY G3 GLY120306Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704077459), received between Jun 22, 2018 and Jul 14, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 22503258 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16138348 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON 26-SEP-2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16138300 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16138274 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16138248 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE (B)(6)-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF DIABETES, UNCONTROLLED HYPERTENSION, UNCONTROLLED HYPERLIPIDEMIA, HEADACHES, MIGRAINES, SLEEP APNEA, TUBAL LIGATION, ROSACEA, FATTY LIVER, HERPES ZOSTER, BENIGN PAROXYSMAL VERTIGO, AND CLASS 2 OBESITY (BMI 37 KG/M2) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED RIGHT MCA BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSION: HEIGHT 4.9MM, DOME 5.2MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO 1.6MM. THE PARENT VESSEL DIAMETER WAS 1.5MM. THE PATIENT UNDERWENT COIL EMBOLIZATION WITH THE IMPLANTATION OF ONE 4MM X 11.5CM MICRUSFRAME 10 COIL (MFR100412 / L10083), ONE 3MM X 6CM GALAXY G3 COIL (GLY120306 / L12402), ONE 2.5MM X 5CM GALAXY G3 COIL (GLY122505 / L11547), ONE 1.5MM X 4CM DELTAFILL 10 COIL (DLF100154 / UNKNOWN LOT NUMBER), AND ONE 1.5MM X 1CM DELTAXSFT 10 COIL (DLXA100151 / UNKNOWN LOT NUMBER) VIA A HEADWAY DUO MICROCATHETER (MICROVENTION) MICROCATHETER. A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED FOR NECK REMODELING. HEPAR

  Patient problems: Infarction, Cerebral; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10824562 ↗
• MalfunctionApr 1, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE (B)(6)-YEAR-OLD MALE PATIENT WITH A HISTORY OF HEADACHES, HYPERTENSION, AND SUBARACHNOID HEMORRHAGE OF A NON-TARGET ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) ON (B)(6) 2019, UNDERWENT TREATMENT OF A SECOND RIGHT MCA ANEURYSM. ANGIOGRAPHY REVEALED A MULTILOBULATED, IRREGULARLY SHAPED UNRUPTURED ANEURYSM AT THE RIGHT MCA BIFURCATION. THE PARENT VESSEL WAS 2.2 MM, ANEURYSM HEIGHT WAS 5.3 MM, AND THE DOME WAS 3.2 MM. THE MAXIMUM ANEURYSM DIAMETER WAS 5.6 MM, THE ANEURYSM NECK SIZE WAS 3.8 MM, AND THE DOME TO NECK RATIO WAS 0.8. THE PATIENT¿S PRE-PROCEDURE MRS SCORE WAS A 2. THE PHYSICIAN CHOSE THE 3MM X 6CM GALAXY G3 COIL (GLY120306 / L12804) AS THE FIRST COIL BUT DURING POSITIONING IN THE ANEURYSM, THIS COIL DID NOT FRAME WELL, THEREFORE, IT WAS NOT USED. THE COIL EMBOLIZATION WAS CONTINUED WITH THE IMPLANTATION OF THE FOLLOWING COILS: A 3.5MM X 6.6 CM MICRUSFRAME 10 COIL (MFR100356 / L10260), A 2 X 4 CM GALAXY G3 MINI COIL (GLM920040 / L11995), A 2 MM X 6 CM GALAXY G3 MINI COIL (GLM920060 / S15173), A 1.5 MM X 3 CM GALAXY G3 MINI COIL (GLM915030 / L13725), A 2 X 4 CM GALAXY G3 MINI COIL (GLM920040 / L14471), AND A 1.5 MM X 3 CM G

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469804 ↗
• MalfunctionJun 22, 2018Material Separation; Material Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 3MM X 6CM GALAXY G3 (GLY120306/L10156) THERMO-MECHANICAL COIL WAS BEING TESTED IN A HEPARINIZED SALINE BATH PRIOR TO USE WHEN A SMALL FRAGMENT OF THE EMBOLIC COIL WAS OBSERVED TO BE DETACHED FROM THE DEVICE. A SMALL PIECE OF THE EMBOLIC COIL APPEARED TO HAVE SEPARATED, BUT THE USER IS NOT SURE IF THE SEPARATION HAD OCCURRED PRIOR TO OPENING DEVICE PACKAGING. THE COIL WAS "DISCARDED" AND REPLACED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE INTENDED PROCEDURE WAS A COIL EMBOLIZATION OF AN UNSPECIFIED ANEURYSM. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING AND NO EVIDENCE OF STERILITY BREACH. NO VISIBLE DAMAGE WAS NOTED TO THE COIL DELIVERY SYSTEM PRIOR TO USE. THE USER DID NOT APPLY EXCESSIVE FORCE WHEN HANDLING THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7630214 ↗