GALAXY G3 GLM910020Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10886704080237), received between Sep 24, 2018 and Apr 10, 2026 — classified as 10 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K171862); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER WAS IN PLACE AND THE 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / 1762505S) WAS DELIVERED TO THE TARGET SITE. THE COIL WAS PACKED IN THE ANEURYSM, AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL AS UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT AND THE CONNECTING CABLE FOR THE MICROCOIL DELIVERY SYSTEM (CCB00015700 / 1412502S) TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE PROCEDURE WAS PROLONGED BY ABOUT 10 MINUTES. ON 06-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE LEFT POSTERIOR COMMUNICATING ARTERY. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE FAULT LIGHT WAS NOT SEEN DURING THE PROCEDURE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ALSO ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT DID NOT ILLUMINATE, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841613 ↗
• MalfunctionMar 26, 2026Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1632516S) WAS IMPEDED IN THE HUB OF THE MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT BE PUSHED INTO THE MICROCATHETER. IT WAS ALSO REPORTED THAT ¿[THE] DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER PREMATURELY.¿ THE PHYSICIAN RETRACED THE COIL AND REPLACED IT WITH A SECOND 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1632516S) AND A THIRD 1.00MM X 4.00CM GALAXY G3 MINI (GLM910040 / 1502508S) IN SUCCESSION, THE SECOND AND THE THIRD COILS WERE ALSO IMPEDED IN THE HUB OF THE MICROCATHETER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE PHYSICIAN RETRACTED THE SECOND AND THE THIRD COIL AND REPLACED IT WITH A FOURTH COIL FROM ANOTHER MANUFACTURER TO FILL THE ANEURYSM AND DETACHED THIS FOURTH COIL. THE PHYSICIAN THEN PROCEEDED TO DELIVER THE FIFTH COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / 2102522S) AND OBSERVED THE DELIVERY WIRE OF THIS FIFTH COIL IN THE DISTAL END OF THE ASSOCIATED MICROCATHETER UNDER IMAGING (NOT YET IN THE BLOOD VESSEL) BUT THE PHYSICIAN COULD NOT OBSERVE THE FIFTH COIL. THE PH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707103 ↗
• InjuryMar 10, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A GALAXY G3 MINI 1MM X 2CM (GLM910020/ 2102522S) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM. DURING THE PROCEDURE, THE USER REPORTED THE COIL COULDN¿T FIT INTO THE ANEURYSM (UNKNOWN REASON) AND THE COIL WAS RESHEATHED, HOWEVER, COULD NOT BE RESHEATHED IN A WAY THAT ALLOWED THE COIL TO BE USED AGAIN LATER. ANOTHER COIL (COMPETITOR BRAND) WAS USED AND THE PROCEDURE WAS COMPLETED. ON 25-FEB-2026, ADDITIONAL EVENT INFORMATION WAS RECEIVED. SUMMARY: PER THE INFORMATION PROVIDED, AN EXCELSIOR SL 10 MICROCATHETER WAS USED (STRYKER). REGARDING WHETHER THE EVENT RESULTED A PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT, IT WAS REPORTED, ¿THE ANEURYSM WAS PERFORATED, SO, WE LOST TIME IN USING ANOTHER COIL.¿ RELEVANT ANATOMICAL INFORMATION WAS REPORTED AS ¿NO RELEVANT TORTUOSITY.¿ RESULTING PATIENT CONSEQUENCES WERE REPORTED AS ¿MORE SUBARACHNOIDAL BLEEDING THAN HAD TO BE.¿ NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24559137 ↗
• MalfunctionDec 22, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, WHEN THE PHYSICIAN FILLED THE ANEURYSM WITH THE 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0308 / 31512427), IT WAS FOUND THAT THE SHAPE OF THE COIL WAS NOT IDEAL. THE PHYSICIAN TRIED TO RETRACT THE COIL TO RE-ADJUST, BUT THE COIL COULD NOT BE RETRACTED INTO INTRODUCER. THE PHYSICIAN REMOVED ONLY THE COIL AND REPLACED IT WITH A NEW COIL, AND IT DETACHED IN THE ANEURYSM. THE PHYSICIAN CONTINUED TO FILL THE ANEURYSM WITH A THIRD COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / 1492531S) AND TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865795 ↗
• MalfunctionOct 15, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A GALAXY G3 MINI 1MM X 2CM (GLM910020/ 1212525S) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED RESISTANCE/FRICTION-DURING ADVANCING THE COIL THROUGH AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCING 1X2 COIL THROUGH EXCELSIOR SL-10 M/C.¿ THERE WERE NO REPORTS OF PATIENT HARM. MEDICAL IMAGING WAS PROVIDED WITH THE COMPLAINT REPORT. THE MEDICAL IMAGING WAS REVIEWED BY CERENOVUS SR. MEDICAL AFFAIRS DIRECTOR ON 19-SEP-2025. THE ASSESSMENT READS AS FOLLOWS: ¿THE DESCRIPTION IS CLEAR. HOWEVER, IT IS UNCLEAR WHETHER THE PROBLEM IS ON THE SIDE OF THE COIL OR THE MICROCATHETER. THE MICROCATHETER CAN, IF USED FOR MULTIPLE COILS, HAVE A DIMINISHED HYDROPHYLIC COATING WHICH MAY HAMPER INTRODUCTION OF A NEXT COIL. IF THE PROBLEM IS IN THE COIL, THIS WILL HAVE TO BE CHECKED BY DOING AN ANALYSIS ON THE RETRIEVED COIL.¿ ADDITIONAL INFORMATION WAS RECEIVED ON 25-SEP-2025. SUMMARY: REGARDING WHETHER THE EVENT RESULTED IN A PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT, IT WAS REPORTED ¿THE PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292422 ↗
• MalfunctionJul 29, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1MM X 2CM GALAXY G3 MINI COIL (GLM910020 / 30865670) WAS IMPEDED IN THE PROXIMAL SECTION OF THE CONCOMITANT MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 25-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE CONCOMITANT MICROCATHETER WAS A PROWLER SELECT PLUS. NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE PRODUCT INVESTIGATION COMPLETED ON 29-JUL-2025, THE ISSUE REPORTED HAS BEEN DETERMINED TO BE REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22657005 ↗
• MalfunctionNov 14, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TO THE INTERNAL CAROTID ARTERY, THE PHYSICIAN DELIVERED A THIRD COIL, A GALAXY G3 MINI 1MM X 2CM (GLM910020, 30865670) WITH AN ECHELON10 MICROCATHETER, WHICH BECAME IMPEDED IN THE MIDDLE SECTION OF THE MC AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE THIRD COIL OUT AND SWITCHED A NEW COIL TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION STATES THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE AND THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THE DEVICE DID NOT APPEAR DAMAGED. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS, THE COIL IS KINKED AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684344 ↗
• MalfunctionJun 5, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, A MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) WAS IN PLACE AND THE COMPLAINT COIL, A 1MM X 2CM GALAXY G3 MINI (GLM910020 / 30772760) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN INSPECTED THE INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECTOR CABLE AND OBSERVED THAT ALL WERE IN GOOD CONDITION. THE PHYSICIAN RETRACTED THE COIL AND THEN REMOVED THE MICROCATHETER AND THE COIL FROM THE PATIENT AND REPLACED THE COIL TO USE WITH THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 04-JUN-2024, PER THE CERENOVUS SALES REPRESENTATIVE, NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473190 ↗
• MalfunctionJun 3, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / 30789541) WAS NOT DETACHED AFTER IT WAS DEPLOYED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ONE PHOTO WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449216 ↗
• MalfunctionApr 1, 2024Stretched; Premature Separation; Stretched; Premature Separation

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION TO THE RIGHT POSTERIOR COMMUNICATING ARTERY, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT ((B)(6)) WAS PARTIALLY RELEASED IN TARGET SITE. THE TWO DISTAL MARKERS OF THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE PHYSICIAN RETRACTED THE STENT AND RELEASED IT AGAIN, BUT IT HAD THE SAME ISSUE. AFTER ADJUSTING ANGLE, THE STENT¿S DISTAL MARKERS WERE STILL EXPANDED INCOMPLETELY. THE DOCTOR REMOVED THE STENT FROM THE PATIENT AND REPLACED A NEW ONE TO RELEASE IT SUCCESSFULLY. THE MICROCATHETER WAS NOT REPLACED. AFTERWARDS, TWO COILS WERE FILLED IN THE ANEURYSM. THE PHYSICIAN STARTED TO FILL THE THIRD COIL USING A GALAXY G3 MINI 1MM X 2CM ((B)(4)), BUT IT CAME OUT IN THE SAME DIRECTION ALL THE TIME. THE COIL WAS RETRACTED AND FOUND TO BE UNRAVELED/STRETCHED. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 18-MAR-2024 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH OF THE ENTERPRISE2 WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011004 ↗
• MalfunctionDec 4, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / 30778025) COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER FROM THE PATIENT¿S ANATOMY TO INSPECT; AFTER INSPECTION, THE COIL WAS OBSERVED IN STRETCHED CONDITION. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259338 ↗
• MalfunctionOct 12, 2023Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR AN ANEURYSM AT THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY, A GALAXY G3 MINI 1MM X 2CM COIL (GLM910020, 30838866) BECAME STUCK IN THE SHEATH DURING INSERTION. IN WHICH COULD NOT BE INSERTED INTO THE PATIENT¿S BODY, AND WAS RETRIEVED. THE PROCEDURE WAS CONTINUED AND COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT BECAUSE THE GALAXY G3 COIL WAS NOT INSERTED INTO THE BODY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT IT WAS NO NECESSARY TO REMOVE OR REPLACE THE UNSPECIFIED MICROCATHETER (MC). NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920425 ↗
• MalfunctionJul 18, 2023Break; Failure to Advance; Break; Failure to Advance

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION OF RUPTURED RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM, SUBARACHNOID HEMORRHAGE (SAH) CASE. AN 8FR LAUNCHER, GUIDEPOST AND PHENOM17 WERE DELIVERED, AND THE COIL EMBOLIZATION WAS INITIATED. AFTER A 3MM X 6CM GALAXY XSFT WAS IMPLANTED AS A FIRST COIL, A GALAXY G3 MINI 1MM X 2CM COIL (GLM910020, 30704815) WAS USED AS A SECOND COIL, AND BECAME STUCK INSIDE THE MICROCATHETER, WHICH COULD NOT BE DELIVERED EVEN PUSHING. THE SHEATH WAS DAMAGED BECAUSE THE COIL WAS PUSHED TOO HARD. THEN THE USER OPENED A NEW GALAXY G3 MINI 1MM X 2CM COIL (GLM910020, 30838866) WHICH BECAME STUCK AS WELL AND UNRAVELED OR EARLY DETACHED INSIDE THE MICROCATHETER DURING RETRIEVAL. THE MICROCATHETER WAS THEN PULLED OUT AND REPLACED WITH ANOTHER NEW PHENOM17. THE EMBOLIZATION WAS COMPLETED WITH USING THE NEW PHENOM17 AND A NEW GALAXY G3 MINI 1MM X 3CM. (THE NEW GALAXY G3 MINI_1X2 WAS NOT AVAILABLE, SO 1X3 WAS USED). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE PHENOM MICROCATHETER, GUIDEPOST CATHETER, 8FRLAUNCHER. BASED ON THE PRE-SHIPMENT PICTURES RECEIVED FOR THE GALAXY G3 MINI 1MM X 2CM, IT WAS NOTED THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341822 ↗
• MalfunctionJun 16, 2023Stretched; Failure to Advance; Premature Separation; Stretched; Failure to Advance; Premature Separation

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION OF RUPTURED RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM, SUBARACHNOID HEMORRHAGE (SAH) CASE. AN 8FR LAUNCHER, GUIDEPOST AND PHENOM17 WERE DELIVERED, AND THE COIL EMBOLIZATION WAS INITIATED. AFTER A 3MM X 6CM GALAXY XSFT WAS IMPLANTED AS A FIRST COIL, A GALAXY G3 MINI 1MM X 2CM COIL (GLM910020, 30704815) WAS USED AS A SECOND COIL, AND BECAME STUCK INSIDE THE MICROCATHETER, WHICH COULD NOT BE DELIVERED EVEN PUSHING. THE SHEATH WAS DAMAGED BECAUSE THE COIL WAS PUSHED TOO HARD. THEN THE USER OPENED A NEW GALAXY G3 MINI 1MM X 2CM COIL (GLM910020, 30838866) WHICH BECAME STUCK AS WELL AND UNRAVELED OR EARLY DETACHED INSIDE THE MICROCATHETER DURING RETRIEVAL. THE MICROCATHETER WAS THEN PULLED OUT AND REPLACED WITH ANOTHER NEW PHENOM17. THE EMBOLIZATION WAS COMPLETED WITH USING THE NEW PHENOM17 AND A NEW GALAXY G3 MINI 1MM X 3CM. (THE NEW GALAXY G3 MINI_1X2 WAS NOT AVAILABLE, SO 1X3 WAS USED). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE PHENOM MICROCATHETER, GUIDEPOST CATHETER, 8FRLAUNCHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144050 ↗
• MalfunctionJun 7, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A POSTERIOR COMMUNICATING ARTERY ANEURYSM, A GALAXY G3 MINI 1MM X 2CM COIL (GLM910020, 30504534) WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL BECAME STUCK INSIDE THE HEADWAY MICROCATHETER (MC), SO THE COIL WAS PULLED OUT AND FOUND UNRAVELED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078978 ↗
• MalfunctionMar 29, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A CEREBRAL COIL EMBOLIZATION OF AN ANEURYSM, THE PHYSICIAN ATTEMPTED TO PEEL AWAY THE GALAXY G3 MINI 1MM X 2CM (GLM910020/30735004) BUT THERE WAS RESISTANCE FELT INSIDE THE SHEATH. THE DEVICE WAS REPLACED WITH ANOTHER SAME SIZED COIL AND OTHER COILS WERE USED WITHOUT ANY PROBLEMS. THE PROCEDURE COMPLETED. CONTINUOUS FLUSH WAS DONE. ON (B)(6) 2023 ADDITIONAL EVENT INFORMATION WAS RECEIVED INDICATING THAT THE TARGET VESSEL WAS DE BASCA. THE MICROCATHETER WAS NOT REMOVED NOR REPLACED. NO DAMAGE WAS REPORTED TO THE DEVICE, NOTING WAS NOTED TO BE OBSTRUCTING THE DEVICE, AND THE DEVICE WAS NOT ABLE TO BE INSERTED INTO THE HUB OF THE MICROCATHETER. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636952 ↗
• MalfunctionFeb 17, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION OF THE POSTERIOR COMMUNICATING ARTERY, A 6F SOFIA SELECT WAS USED AS INTERMEDIATE CATHETER FROM A GUIDING CATHETER (8F LOADMASTER) AND COIL EMBOLIZATION STARTED. TWO MICROCATHETERS (PHENOM) (SL-10) WERE IMPLANTED AT THE ANEURYSM. TARGET AND AXIUM COIL(S) WERE INSERTED INTO THE ANEURYSM, BUT THESE COILS DID NOT FIT AS INTENDED. A STENT (ATLAS) WAS DEPLOYED FROM THE SL-10. AFTER THAT, THREE COILS WERE IMPLANTED, AND A GALAXY G3 MINI 1MM X 2CM COIL (GLM910020, 30558112) WAS USED. THE COMPLAINT COIL WAS INSERTED INTO THE PHENOM BUT THERE WAS RESISTANCE FELT INSIDE THE MICROCATHETER. THE GALAXY G3 MINI 1MM X 2CM COIL WAS REMOVED AND THE PROCEDURE COMPLETED. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THERE WAS NO DEVICE DAMAGE REPORTED. IT WAS FURTHER CLARIFIED THAT THE DEVICE COULD BE MOVED. THERE WAS NOTING NOTED TO BE OBSTRUCTING THE MICROCATHETER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL IS SLIGHTLY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400241 ↗
• MalfunctionNov 28, 2022Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ARTERIAL CONICA, THE PHYSICIAN FELT SOME RESISTANCE WITH A GALAXY G3 MINI COIL 1MM X 2CM (GLM910020, 30683263) DURING THE PROCESS OF DELIVERING COIL TO THE ECHOLON10 MICROCATHETER (MC). WHEN THE COIL WAS IN THE TARGET POSITION, THE DOCTOR TRIED TO DETACH COIL, BUT THE COIL WAS UNABLE TO DETACH. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870247 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 62-YEAR-OLD FEMALE PATIENT (B)(6) UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY ANTERIOR CIRCULATION ANEURYSM ON 01-APR-2021. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 6.5MM, DOME 4.2MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 2.9MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.4MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 5MM X 15CM (GLY120515 / L13767), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575 /K10486), A GALAXY G3 XSFT 3MM X 6M (GLX120306 /30399443), A GALAXY G3 MINI 2MM X 6CM (GLM920060 /30366491), A GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /L14642), GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /30393176), GALAXY G3 MIMI 1MM X 3CM (GLM910030 /30422323), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /K10600), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /30390764) AND A 1MM X 1.5CM GALAXY G3 MIMI (GLM910015, 30390761) WERE IMPLANTED. A LVIS STENT (MICROVENTION) WAS ALSO IMPLANTED, AND A BALLOON CATHETER (UNKNOWN CATALOG/MANUFACTURER) WAS ALSO USED. ALL CO

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Vasoconstriction

  MAUDE report 15714101 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 62-YEAR-OLD FEMALE PATIENT (B)(6) UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY ANTERIOR CIRCULATION ANEURYSM ON (B)(6) 2021. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 6.5MM, DOME 4.2MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 2.9MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.4MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 5MM X 15CM (GLY120515 / L13767), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575 /K10486), A GALAXY G3 XSFT 3MM X 6M (GLX120306 /30399443), A GALAXY G3 MINI 2MM X 6CM (GLM920060 /30366491), A GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /L14642), GALAXY G3 MINI 1.5MM X 3CM (GLM915030 /30393176), GALAXY G3 MIMI 1MM X 3CM (GLM910030 /30422323), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /K10600), A GALAXY G3 MIMI 1MM X 2CM (GLM910020 /30390764) AND A 1MM X 1.5CM GALAXY G3 MIMI (GLM910015, 30390761) WERE IMPLANTED. A LVIS STENT (MICROVENTION) WAS ALSO IMPLANTED, AND A BALLOON CATHETER (UNKNOWN CATALOG/MANUFACTURER) WAS ALSO USED. ALL CO

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Vasoconstriction

  MAUDE report 15714074 ↗
• MalfunctionOct 12, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1MM X 2CM GALAXY G3 COIL (GLM910020, 30633448) WAS USED AS THE SECOND COIL. HOWEVER, THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587529 ↗
• MalfunctionOct 3, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1MM X 2CM GALAXY G3 COIL (GLM910020, 30611666) WAS USED AS THE FOURTH COIL. THE PHYSICIAN FELT STRONG RESISTANCE WHILE ADVANCING THE PROWLER LPES AT THE PROXIMAL AREA. THE PHYSICIAN USED A SAME LIKE PRODUCT. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527391 ↗
• MalfunctionSep 27, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1MM X 2CM GALAXY G3 MINI COIL (GLM910020, 30624669) WAS USED AS THE THIRD COIL. HOWEVER, THE PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCING GALAXY G3 MINI COIL THROUGH THE UNSPECIFIED MICROCATHETER (MC). THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494037 ↗
• InjurySep 23, 2022Entrapment of Device; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Migration; Entrapment of Device; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 47-YEAR-OLD FEMALE PATIENT UNDERWENT A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING A 3.5MM BASILAR ARTERY (BA) ANEURYSM, A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) WAS DEPLOYED VIA A PROWLER SELECT PLUS MICROCATHETER AND PLACED AT THE IDEAL POSITION ON THE FIRST ATTEMPT. AFTER THAT, AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS DELIVERED TO THE LESION. THE MICROCATHETER WAS SET EXACTLY AT THE MIDDLE OF FOUR MARKERS ON THE PULSERIDER LEAFLET. TWO COIL EMBOLIZATION VIA THE TRANSCELL TECHNIQUE WERE PERFORMED WITHOUT ANY ISSUES. WHEN THE THIRD COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / LOT# UNKNOWN) WAS INSERTED, IT WAS REPORTED THAT THE COIL PENETRATED THE RIGHT UPPER PART OF THE ANEURYSM WHICH RESULTED IN BLEEDING. THIS THIRD COIL WAS DESCRIED AS ¿WOUND OUTSIDE THE ANEURYSM AS IT WAS, AND THE COIL WAS LEFT FOR A WHILE.¿ ANGIOGRAPHY WAS TAKEN AGAIN AFTER A WHILE AND IT WAS CONFIRMED THAT THE BLEEDING HAD STOPPED. AFTER THAT, IT WAS REPORTED THAT THE PULSERIDER WAS PROMPTLY DETACHED AND THE PROWLER SELECT PLUS MICROCATHETER WAS REMOVED. THE COIL WAS DETA

  Patient problems: Aneurysm; Intracranial Hemorrhage

  MAUDE report 15473710 ↗
• MalfunctionSep 12, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1MM X 2CM GALAXY G3 COIL (GLM910020, 30633448) WAS BEING USED AS THE THIRD COIL. THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401406 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171862. One submission often covers many models, so check the product and lot details in each record.

• Z-2280-2019 · May 16, 2019 · Terminated
  GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).