GALAXY G3 GLY123509Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704077442), received between Jul 6, 2018 and Jul 24, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Separation Failure; Material Split, Cut or Torn; Separation Failure; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF BRANCH ARTERY (INFERIOR MESENTERIC ARTERY, LUMBAR) PRIOR TO STENT GRAFT IMPLANTATION AND AFTER 1 J& J COIL WAS IMPLANTED, A GALAXY G3 3.5MM X 9CM COIL (GLY123509, 30704827) WAS USED AS A SECOND COIL. THE GLY123509 WAS PLACED AT THE TARGET LESION AND ATTEMPTED TO DETACH THE COIL USING EMPOWER CONTROL CABLE (ECB000182-00) BUT COULD NOT. REPEATED TO DETACH FOR 3 TIMES BUT COULD NOT DETACH THE COIL. REBOOTED THE CONTROL BOX, BUT THE ISSUE CONTINUED. PLANNED TO RETRIEVE THE GLY123509 AND REPLACE THE ECB000182-00. DURING RETRIEVAL OF THE GLY123509, THE SHEATH BROKE AND COULD NOT RE-SHEATH THE COIL, SO REPLACED THE GLY123509 WITH ANOTHER NEW ONE WITH SAME LOT, AND THE ECB000182-00 WITH ANOTHER NEW ONE WITH DIFFERENT PRODUCT CODE, WHICH WERE USED AND IMPLANTED WITH NO ISSUES. TOTAL 9 J&J COILS WERE IMPLANTED TO 4 TARGET VESSELS, AND THE STENT GRAFT IMPLANTATION WAS INITIATED. THERE WAS NO IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH DONE. ADDITIONAL EVENT INFORMATION RECEIVED ON 19-JUL-2024 INDICATED THAT NO NECK REMODELING WAS UTILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819668 ↗
• MalfunctionJul 31, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TARGETING AN UNRUPTURED BASILAR TOP ANEURYSM, AFTER THE LEFT FEMORAL ARTERY WAS PUNCTURED USING THE FUBUKI DILATOR KIT (ASAHI INTECC), A GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL), AN EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER) WITH A SYNCHRO SELECT¿ GUIDEWIRE (STRYKER) WERE INSERTED. A 6MM X 20MM TARGET® 360 COIL (STRYKER), A 5MM X 15CM GALAXY G3 (GLY120515 / LOT# UNKNOWN), AND A 3.5MM X 9CM GALAXY G3 XSFT (GLX123509 / LOT# UNKNOWN) WERE PLACED. THE COMPLAINT COIL, A 3.5MM X 9CM GALAXY G3 (GLY123509 / 30704827) WAS THE FOURTH COIL; WAS PLACED AND AN ATTEMPT TO DETACH WAS MADE. THE ELECTRICAL CONTINUITY COULD NOT BE CONFIRMED. THE ENPOWER CONTROL CABLE (ECB00018200 / 30989108) WAS REPLACED, BUT THE LED INDICATOR DID NOT ILLUMINATE, AND THE COMPLAINT COIL WAS NOT DETACHED. IT WAS RETRIEVED AND REPLACED WITH A 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575), WHICH WAS IMPLANTED. AFTER THAT, THE FOLLOWING COILS WERE IMPLANTED: A 3.5MM X 5CM GALAXY G3 XSFT (GLX123505), A 2MM X 3CM IED SILKY SOFT COIL (KANEKA), AND 2MM X 2CM IED SILKY SOFT COIL (KANEKA) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431259 ↗
• MalfunctionJul 11, 2023Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE FOR AN EMERGENT BLEED, AFTER THE MICROCATHETER, A MARVEL® MICROCATHETER (TOKAI MEDICAL PRODUCTS) APPROACHED THE SITE OF THE BLEED AND THE COMPLAINT COIL, A 3.5MM X 9CM GALAXY G3 (GLY123509 / 30397648) WAS DELIVERED. IT WAS REPORTED THAT THE MICROCATHETER KICKED BACK AND THE COIL WAS UNABLE TO BE WOUND AS INTENDED. AS A RESULT, THE COIL WAS WITHDRAWN, BUT IT COULD NOT BE RE-SHEATHED. CONTINUOUS FLUSH WAS NOT MAINTAINED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING OTHER COILS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 10-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL FAILED TO CONFORM TO THE ANEURYSM WALL; IT DID NOT HERNIATE NOR PROTRUDED INTO THE PARENT VESSEL. NO NECK REMODELING WAS USED. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER FROM THE TARGET WHEN THE COIL WAS WITHDRAWN. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 10-JUL-2023, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302219 ↗
• MalfunctionMay 5, 2023Stretched; Positioning Problem; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOMM), AFTER IMPLANTATION OF THE STENT, THE COIL EMBOLIZATION WAS CONDUCTED VIA TRANS-CELL METHOD. THE COMPLAINT COIL, A 3.5MM X 9CM GALAXY G3 (GLY123509 / 30704827) WAS USED AS THE FIFTH COIL. IT WAS REPORTED THAT THE COMPLAINT COIL DID NOT WIND AT THE TARGET LESION AND HAD TO BE RE-SHEATHED AND REWOUND SEVERAL TIMES. ¿AT THAT TIME, POPPING WAS FELT IN HAND AND THE COIL WAS UNRAVELED.¿ THE COIL WAS STILL IN THE CONCOMITANT PHENOM¿ MICROCATHETER (MEDTRONIC) AND WAS RETRIEVED WITH THE MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MICROCATHETER AND COIL. IT WAS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16879613 ↗
• MalfunctionFeb 6, 2023Stretched; Difficult to Advance; Premature Separation; Stretched; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT AN ANEURYSM WAS CONFIRMED AT THE GASTRODUODENAL ARTERY (GDA), AND COIL EMBOLIZATION WAS PERFORMED. IT WAS INITIALLY PLANNED TO EMBOLIZE THE ANEURYSM, ¿BUT APPROACH WAS IMPOSSIBLE RESULTING IN A MATERNAL EMBOLISM.¿ DETAILS OF THE PROCEDURE IS AS FOLLOWS: A SHEPHERD HOOK CATHETER (MERIT MEDICAL) APPROACHED THE CELIAC ARTERY WITH THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30883120). THE PROWLER SELECT PLUS MICROCATHETER APPROACHED FOR ANEURYSM ISOLATION AND COIL EMBOLIZATION WAS INITIATED. THE COMPLAINT COIL, A 3.5MM X 9CM GALAXY G3 (GLY123509 / 30704828) WAS FLUSHED AS CONTINUOUS FLUSH WAS NOT MAINTAINED. HOWEVER, IT WAS REPORTED THAT THE COMPLAINT COIL WAS UNABLE TO ADVANCE THROUGH THE MIDDLE PART OF THE MICROCATHETER. RESISTANCE WAS FELT. THE DELIVERY WIRE WAS RETRACTED BUT THERE WAS NO COIL; THE PHYSICIAN JUDGED THAT THE COMPLAINT COIL HAD UNRAVELED. THE COIL AND MICROCATHETER WERE REMOVED. THE PROWLER SELECT PLUS MICROCATHETER WAS REPLACED WITH A TERUMO MICROCATHETER AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER 3.5MM X 9CM GALAXY G3 (GLY123509). THE REPLACEMENT COIL WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305474 ↗
• MalfunctionDec 14, 2022Entrapment of Device; Stretched; Entrapment of Device; Stretched

  THE HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH), THE DOUBLE CATHETER TECHNIQUE WAS USED FOR THE COIL EMBOLIZATION OF THE TARGET ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM). THE FIRST COIL, A 6MM X 15CM GALAXY G3 (GLY120615 / 30526872) WAS USED AS A FRAMING COIL WITH THE FIRST MICROCATHETER (UNSPECIFIED BRAND), HOWEVER, THE COIL WAS UNABLE TO BE DETACHED. THEREFORE, IT WAS REPORTED THAT A SECOND COIL, A 3.5MM X 9CM GALAXY G3 (GLY123509 / LOT# UNKNOWN) WAS USED TOGETHER WITH ANOTHER MICROCATHETER (UNSPECIFIED BRAND). AN ATTEMPT TO IMPLANT THE SECOND COIL, BUT IT BECAME ENTANGLED WITH THE FIRST COIL. THIS COIL WAS MOVED BUT IT UNRAVELED. THE COIL WAS THEN REMOVED ¿BY BEING COVERED WITH THE MICROCATHETER¿ AND THE SECOND COIL WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH NEW COIL(S). THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE COMPLAINT REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED. THE FOLLOWING WERE LISTED AS CONCOMITANT DEVICES: EXCELSIOR® SL-10® MICROCATHETER (STRYKER), Y-CONNECTOR (TERUMO), AND AN ENPOWER DCB 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983514 ↗
• MalfunctionAug 23, 2022Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR UNRUPTURED MIDDLE CEREBRAL ARTERY ANEURYSM, A 3.5MM X 9CM GALAXY G3 COIL (GLY123509, 30710693) WAS USED AS THE FIRST COIL. HOWEVER, THE COIL DID NOT FIT THE ANEURYSM WALL. THE COMPLAINT COIL WAS RE-SHEATHED BUT BECAME UNRAVELED. THE COMPLAINT COIL WAS REMOVED TOGETHER WITH AN UNSPECIFIED MICROCATHETER (EXSELSIOR SL10) WHICH HAD BEEN DELIVERED TO THE ANEURYSM. AFTER THAT, THE SAME MICROCATHETER WAS INSERTED AND ADVANCED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED AFTER COILING EMBOLIZATION. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274860 ↗
• MalfunctionApr 19, 2022Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENT COIL EMBOLIZATION PROCEDURE TARGETING AN INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) ANEURYSM, AFTER PREPARATION IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU), COIL EMBOLIZATION WAS INITIATED. ALTHOUGH THE 3.5MM X 9CM GALAXY G3 COIL (GLY123509 / 30704828) WAS SELECTED AND USED, THERE WAS RESISTANCE FELT BETWEEN THE COIL AND THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT AND A COMPETITOR COIL WAS USED AS REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. PRELIMINARY PHOTO IMAGES OF THE COMPLAINT DEVICE WERE CAPTURED BY THE J&J JAPAN AFFILIATES AND INCLUDED IN THE COMPLAINT (B)(6) 2022. BASED ON THE REVIEW OF THE PHOTOS BY THE PRODUCT ANALYSIS LAB COMPLETED (B)(6) 2022, THE EMBOLIC COIL WAS NOTED TO BE IN STRETCHED CONDITION INSIDE THE INTRODUCER. BASED ON THE REVIEW OF THE PHOTOS, THE EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14151788 ↗
• MalfunctionSep 27, 2021Device Difficult to Setup or Prepare; Material Rupture; Positioning Problem; Device Difficult to Setup or Prepare; Material Rupture; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A CEREBRAL COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM, A GUIDING SHEATH (6FR) WAS INSERTED, AND AN APPROACH WAS MADE TOWARD THE RIGHT INTERNAL INTRACRANIAL CAROTID ARTERY (ICA). TWO MICROCATHETERS, A SL10, STRYKER AND A HEADWAY17, TERUMO WERE DELIVERED TO THE LESION. COIL EMBOLIZATION STARTED. THE COMPLAINT COIL, A GALAXY G3 3.5MM X 9CM (GLY123509, L13343) WAS INSERTED FROM THE SL10 MICROCATHETER (MC). THE CATHETER KICKED BACK WHEN THE COMPLAINT COIL WAS BEING RE-WINDED SEVERAL TIMES. THE COMPLAINT COIL WAS RE-SHEATHED BUT IT WAS NOT ABLE TO BE RE-SHEATHED. THE WIRE WAS EXPOSED FROM A PART OF THE COMPLAINT COIL AND IT WAS NOT ABLE TO BE BACK. IT WAS REMOVED FROM THE MICROCATHETER AND REPLACED WITH ANOTHER COIL AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT INJURY REPORTED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC. THERE WAS NO RESISTANCE THAT OCCURRED DURING THE PROCEDURE. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THE LESION WAS THE LEFT INTERNAL CAROTID POSTERIOR COMMUNICATING (ICPC). NO ADDITIONAL INTERVENTION WAS REQUIRED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12536516 ↗
• InjuryJul 22, 2021Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM IN A FEMALE PATIENT, A PULSERIDER 8T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3051697019) WAS ALLEGEDLY DEPLOYED AS PER THE INSTRUCTIONS FOR USE (IFU) IN A HYBRID POSITION FROM THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) TO THE ANEURYSM (I.E., PARTIALLY INTRAANEURYSMAL). A CONCOMITANT SL-10® MICROCATHETER (STRYKER) USED FOR COIL DELIVERY WAS ADVANCED TO THE ANEURYSM VIA TRANS-CELL APPROACH. A 4MM X 10CM GALAXY G3 COIL WAS USED BUT THE SIZE DID NOT FIT SO IT WAS REPLACED WITH A 3MM X 8CM GALAXY G3 COIL. HOWEVER, COIL WAS DEEMED TOO SMALL FOR THE ANEURYSM. THE COIL WAS REPLACED WITH A 3.5MM X 9CM GALAXY G3 COIL (GLY123509 / LOT#: UNKNOWN). THE COIL WAS REWINDED MULTIPLE TIMES, BUT IT WAS NOT ABLE TO FRAME THE ANEURYSM AS INTENDED. THE COIL WAS REPLACED WITH A 3MM X 6CM COMPETITOR COIL, BUT IT WAS ALSO NOT ABLE TO BE WINDED AS INTENDED. THEREFORE, THE COMPETITOR COIL WAS REMOVED AS WELL. THE GUIDEWIRE (BRAND NOT SPECIFIED) WAS REINSERTED, AND THE PHYSICIAN CHANGED THE POSITION OF THE MICROCATHETER. HOWEVER, ANGIOGRAPHY CONFIRMED THAT BLEED

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 12211741 ↗
• MalfunctionFeb 12, 2019Stretched; Unraveled Material; Physical Resistance/Sticking; Stretched; Unraveled Material; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE INTERNAL CAROTID ARTERY, THE 3.5 MM X 9 CM GALAXY G3 COIL (GLY123509 / L12978) WAS INSERTED INTO THE HEADWAY® 17 MICROCATHETER (MICROVENTION), THEN THE PHYSICIAN ATTEMPTED TO CHANGE THE POSITION OF THE MICROCATHETER SO THE COIL WAS RE-SHEATHED AND WAS THEN RE-INSERTED INTO THE MICROCATHETER. THE PHYSICIAN EXPERIENCED RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER. THE PHYSICIAN PUSHED THE DELIVERY WIRE TO DELIVER THE COIL, BUT THE COIL SIZE WAS CONFIRMED TO BE NOT APPROPRIATE. THE COIL WAS REPORTED TO BECOME UNRAVELED RESULTING IN THE REMOVAL OF THE MICROCATHETER. ANOTHER COIL WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332021 ↗
• MalfunctionJul 6, 2018Unraveled Material; Material Deformation; Unraveled Material; Material Deformation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN UNRUPTURED ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE GUIDE CATHETER (CERULEAN, MEDIKIT) AND THE MICROCATHETER (SL10, STRYKER) WERE INSERTED INTO THE TARGET SITE TO MAKE A FRAME USING A GALAXY G3 4 X 10 COIL, BUT THE SIZE OF THE COIL DID NOT FIT AND THE COIL WAS RE-SHEATHED. THE GALAXY G3 3.5 MM X 9 CM COIL (GLY123509 / L11078) WAS INTRODUCED INTO THE MICROCATHETER AND THE SIZE ALSO DID NOT FIT. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL BUT THE COIL WAS KINKED / KNOTTED AND BECAME UNRAVELED. THE COIL AND THE MICROCATHETER WERE REMOVED AND THE TARGET SOFT 3 X 8 COIL WERE IMPLANTED. THE PROCEDURE WAS COMPLETED AND THE ANEURYSM WAS FILLED WITH COILS. THERE WERE NO FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7666993 ↗