GALAXY G3 GLM915040Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10886704080152), received between Sep 9, 2019 and Mar 23, 2026 — classified as 4 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Stretched” (10 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE GALAXY G3 MINI 1.5 MM X 4 CM (GLM915040/1952526S) WAS IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO MICROCATHETER. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW COIL. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. A JOHNSON & JOHNSON MICROCATHETER WAS USED. THE DEVICE DID NOT APPEAR PHYSICALLY DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE INTRODUCER. CONTINUOUS FLUSH WAS MAINTAINED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS KINKED AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664898 ↗
• MalfunctionApr 28, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A NON J&J MICROCATHETER WAS IN PLACE AND A GALAXY G3 MINI 1.5MM X 4CM COIL (GLM915040, 30952252) 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 INSPECTED INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECT CABLE, AND OBSERVED ALL WERE IN GOOD CONDITION. THE DOCTOR PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH, THEN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919031 ↗
• MalfunctionJul 10, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, DURING THE ATTEMPT TO RE-SHEATH THE COMPLAINT COIL, A 1.50MM X 4.00CM GALAXY G3 MINI (GLM915040 / 30719521), THE INTRODUCER FAILED TO BE RE-ZIPPED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED AND RECEIVED ON 11-JUN-2024. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 10-JUL-2024, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716388 ↗
• MalfunctionMar 21, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.50MM X 4.00CM GALAXY G3 MINI COIL (GLM915040 / 30710672) FAILED TO DETACH. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956608 ↗
• MalfunctionFeb 5, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A GALAXY G3 MINI 1.5MM X 4CM COIL (GLM915040, 30896012). IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640898 ↗
• MalfunctionJan 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 1.50MM X 4.00CM GALAXY G3 MINI (GLM915040 / 30768307) FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. IT WAS REPORTED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509240 ↗
• MalfunctionJan 11, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GALAXY G3 MINI 1.5MM X 4CM (GLM915040/ 30757505) COIL WAS IMPEDED IN THE DISTAL END OF A CERENOVUS MICROCATHETER (PRODUCT/LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 22-NOV-2023 INDICATED THAT THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER (MC). A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18493423 ↗
• MalfunctionJul 14, 2023Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM, THE COMPLAINT COIL, A 1.50MM X 4.00CM GALAXY G3 MINI (GLM915040 / 30729905) BECAME DETACHED MID-DEPLOYMENT. THE COIL WAS PARTIALLY IN THE ANEURYSM AND PARTIALLY OUTSIDE THE ANEURYSM IN THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) THAT WAS JAILED BETWEEN THE VESSEL WALL AND THE SILK VISTA FLOW DIVERTER (BALT). THE MICROCATHETER WAS REMOVED, BUT THE REMAINDER OF THE COIL STAYED IN THE VESSEL. THERE WAS NO FRAGMENT OF COIL IN THE MICROCATHETER UPON INSPECTION. IT WAS REPORTED THAT THE COMPLAINT COIL WAS THE TENTH COIL THAT WAS DEPLOYED IN THE ANEURYSM. NO FURTHER COILS WERE DEPLOYED. THE PHYSICIAN COMMENTED THAT THERE WAS NO RISK TO THE PATIENT. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 11-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS ON THE POSTERIOR COMMUNICATING ARTERY (PCOM). THE COIL DID DETACH AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT (DPU). THE INFORMATION INDICATED THAT THE COIL DID NOT BREAK INTO TWO PIECES. ¿THE COIL STAYED IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329796 ↗
• MalfunctionDec 16, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE VERTEBRAL ARTERY, ONE G3 COIL AND ON3 G3 XSFT COIL WERE DETACHED. AFTER THAT, THE FIRST COMPLAINT COIL, A GALAXY G3 MINI 1.00MM X 4.00CM (GLM910040 / 30722166) WAS USED, BUT THERE WAS INTENSIVE RESISTANCE FELT ¿AS IF THE COMPLAINT COIL GOT STUCK ON THE HUB¿ OF THE CONCOMITANT PHENOM¿ 17 MICROCATHETER (MEDTRONIC) THE DELIVERY WIRE WAS RETRACTED BUT IT GOT KINKED AT THE COIL DETACHMENT ZONE. IT WAS REPORTED THAT IT IS NOT KNOWN WHEN THE KINK OCCURRED, BUT ¿THERE WAS REMARKABLE RESISTANCE FELT WHEN THE DELIVERY WIRE WAS INSERTED INTO THE MICROCATHETER.¿ THERE WAS NO STOCK OF THE GALAXY G3 MINI 1.00MM X 4.00CM AVAILABLE AT THE FACILITY, AS A RESULT, A GALAXY G3 MINI 1.50MM X 4.00CM (GLM915040 / 30541404), THE SECOND COMPLAINT COIL WAS USED, BUT IT WAS UNABLE TO ADVANCE AT THE HUB OF THE CONCOMITANT MICROCATHETER. THIS COIL WAS REPLACED WITH A GALAXY G3 MINI 1.00MM X 3.00CM (GLM910030) AND IT WAS DELIVERED TO THE TARGET LESION AND IMPLANTED WITHOUT ANY PROBLEMS. TWO ADDITIONAL COILS, ANOTHER GALAXY G3 MINI 1.00MM X 3.00CM (GLM910030) AND A GALAXY G3 MINI 1.00MM X 2.00CM (GLM910020

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000586 ↗
• MalfunctionOct 7, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY, A GUIDING CATHETER, AN UNSPECIFIED DISTAL ASSESS CATHETER (DAC) AND A EXSELSIOR SL10 MICROCATHETER (MC) APPROACHED TO THE LESION. A 1.5MM X 4CM GALAXY G3 MINI COIL (GLM915040, 30704818) WAS USED AS THE FIFTH COIL AFTER FOUR J&J COILS WERE IMPLANTED. THE 1.5MM X 4CM GALAXY G3 MINI COIL WAS TRIED TO BE USED IN THE SAME WAY AS THE PREVIOUS FOUR COILS. HOWEVER, THERE WAS RESISTANCE FELT IN THE MICROCATHETER AND THE COMPLAINT COIL WAS UNABLE TO BE INSERTED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL. THE REPLACEMENT COIL WAS USED WITHOUT ANY PROBLEMS. THE PROCEDURE COMPLETED WITH SEVEN J&J COILS. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. THE STATUS OF THE PATIENT HAS BEEN STABLE. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THEY WERE NO ABLE TO MOVE THE DEVICE. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15562115 ↗
• MalfunctionMay 13, 2022Separation Failure; Migration; Separation Failure; Migration

  AS REPORTED BY THE STERLING STUDY, A 36-YEAR-OLD MALE (SUBJECT 01418-003) WITH NO SIGNIFICANT MEDICAL HISTORY UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT MIDDLE CEREBRAL ARTERY ANEURYSM ON (B)(6) 2022. HUNT & HESS GRADE SCORE WAS 1 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. DISCHARGE INFORMATION WAS NOT PROVIDED. IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED ON (B)(6) 2022 REVEALED A RUPTURED LEFT MIDDLE CEREBRAL ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 3.3MM, DOME 6.9MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 3.0MM, AND DOME-TO-NECK RATIO 2.3MM. THE PARENT VESSEL DIAMETER WAS 2MM. PER THE CASE REPORT FORM (CRF), THE FOLLOWING COILS WERE IMPLANTED VIA AN EXCELSION SL-10 (STRYKER) MICROCATHETER: ONE 4MM X 10MM GALAXY G3 (GLY120410/30550298), ONE 2MM X 4MM GALAXY G3 XTRASOFT (GLX120204/30371925), ONE 2MM X 4 CM GALAXY G3 MINI (GLM920040/30392248) AND ONE 1.5MM X 4CM GALAXY G3 MINI (GLM915040/30409519). DURING COILING OF THE 1.5MM X 4CM GALAXY G3 MINI (GLM915040/30409519) A COIL PROLAPSE/HERNIATION OCCURRED INTRA-PROCEDURE. AFTER THE COIL WAS ¿DETACHED¿, WHEN THE MICROCATHETER WAS REMOVED FROM THE SAC, THE COIL WAS IN FACT PARTIALLY DETACHED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14396819 ↗
• MalfunctionApr 28, 2022Separation Failure; Migration; Separation Failure; Migration

  AS REPORTED VIA THE STERLING REGISTRY (SUBJECT (B)(4)), THIS WAS A COIL EMBOLIZATION TO AN ANEURYSM AT THE LEFT MIDDLE CEREBRAL ARTERY (ANTERIOR CIRCULATION). AFTER THE 1.5MM X 4CM GALAXY G3 COIL (GLM915040, 30409519) ¿DETACHED¿ AND WHEN THE EXCELSION SL-10 MICROCATHETER (MC) WAS REMOVED FROM THE SAC, THE COIL WAS IN FACT PARTIALLY DETACHED AND WAS PULLED OUT OF THE ANEURYSM, LEAVING 1 LARGE LOOP OUTSIDE. THE MOVEMENT OF THE MICROCATHETER COMPLETED THE DETACHMENT BY INDUCING MORE KINK ON THE DETACHMENT ZONE WHICH RUPTURED AFTER THE COIL WAS PARTIALLY PULLED OUT OF THE ANEURYSM, LEAVING NO POSSIBILITY FOR COIL REPOSITIONING. WE OPTED FOR NO ADDITIONAL MANEUVER, AS THE COIL WAS ANCHORED IN THE ANEURYSM, AND THE EXTRUDED LOOP WAS IN THE FLOW OF THE SUPERIOR BRANCH. THE COIL WAS NOT REMOVED FROM THE PATIENT; IT WAS LEFT PROTRUDING OUTSIDE THE ANEURYSM, WITH A PULSATILE PATTERN. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE OUTCOME AS A RESULT OF THE EVENT NOR WAS THERE ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO INTRA-OPERATIVE THROMBOEMBOLIC EVENT. IT WAS REPORTED THAT THERE WAS MICROCATHETER KICKBACK EXPERIENCE. THE SIDE WALL RUPTURED ANEURYSM HAD A PARENT VESSEL DIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240630 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA (B)(6), A (B)(6)FEMALE (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF CONTROLLED HYPERTENSION UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) ON (B)(6)2021. THE PATIENT EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6)2022. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED AT THE 180-DAY (6-MONTH) FOLLOW-UP VISIT ON (B)(6)2022 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. SHE SUBSEQUENTLY UNDERWENT ANEURYSM RETREATMENT DUE TO RESIDUAL ANEURYSM ON (B)(6)2022. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6)2021 REVEALED A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 6MM, DOME 4MM, MAXIMUM ANEURYSM DIAMETER 6MM, NECK SIZE 4MM, AND DOME-TO-NECK RATIO 1.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED ON (B)(6)2021. A TOTAL OF FOUR CERENOVUS COILS WERE IMPLANTED DURING THE PROCEDURE: GALAXY G3 7MM X 21CM (GLY120721, 30470358), GALAXY G3 XSFT HEL 2MM X 8CM (GLX120208, 3045189), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30504557) AND GALAXY G3 MINI 1.5MM X 4CM (

  Patient problems: Aneurysm

  MAUDE report 14022286 ↗
• MalfunctionDec 14, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.50MM X 4.00CM GALAXY G3 MINI COIL (GLM915040 / L14569) WOULD NOT DETACH AFTER THE DETACHMENT BUTTON WAS PRESSED TWICE. THE HUB DID NOT GET WET. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. ON 09 DEC 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE COMPLAINT COIL WAS USED WITH A HEADWAY® DUO MICROCATHETER (MICROVENTION). THE INFORMATION ALSO INDICATED THAT THE PHYSICIAN USED THE HEADWAY DUO MICROCATHETER, WHICH IS ¿.0165 BUT TAPERS TO .013 TIP¿ AND THIS MAY HAVE BEEN WHAT CAUSED THE ISSUE WITH THE COIL NOT DETACHING. IT WAS REPORTED THAT THE GREEN SYSTEM READY LIGHT WAS ILLUMINATED AND DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATE AND THE AUDIBLE SIGNAL BEEP WAS HEARD. THE SAME MICROCATHETER WAS NOT USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006435 ↗
• MalfunctionDec 9, 2021Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, THE COIL PUSHER OF A GALAXY G3 MINI COIL 1.5MM X 4CM (GLM915040, 30360503) IS KINKED. NO PATIENT INJURY WAS REPORTED. BASED ON THE VISUAL ANALYSIS OF THE DEVICE PICTURES RECEIVED, THE CORE WIRE WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968268 ↗
• MalfunctionNov 10, 2021Break; Break

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION FOR AN ARTERIOVENOUS FISTULA (DAVF), A MICROCATHETER WAS INSERTED AND DELIVERED TO THE LESION AND COIL EMBOLIZATION BEGAN. THE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / L14071) AND THE 1.50MM X 4.00CM GALAXY G3 MINI (GLM915040 / L13976) WERE USED AND WERE RE-SHEATHED. HOWEVER, THE INTRODUCER SHEATHS BECAME DAMAGED AND THE COILS WERE NO LONGER ABLE TO BE USED. THE COMPLAINT COILS WERE REPLACED WITH SAME SIZE COILS AND THE PROCEDURE WAS COMPLETED. IT WAS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED. ADDITIONAL INFORMATION WAS RECEIVED ON 03-NOV-2021. THE INFORMATION INDICATED THAT THERE WAS NO RESISTANCE AT ANY TIME DURING THE COIL ADVANCEMENT THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED INSIDE THE INTRODUCER IN A DAMAGED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 08-NOV-2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791055 ↗
• MalfunctionNov 8, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE WITH THE TARGET ANEURYSM LOCATED AT THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC), THE 1.50MM X 4.00CM GALAXY G3 MINI COIL (GLM915040 / L14811) GOT IMPEDED INSIDE THE CONCOMITANT PHENOM¿ 21 MICROCATHETER (MEDTRONIC). IT WAS REPORTED THAT THERE WAS CONTINUOUS FLUSH THROUGH THE MICROCATHETER. THE COMPLAINT COIL WAS REMOVED WITH THE MICROCATHETER AND REPLACED WITH ANOTHER COIL. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION ASSOCIATED WITH THE REPORTED DEVICE ISSUE. THE COMPLAINT COIL IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771520 ↗
• MalfunctionNov 8, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI COIL 1.5MM X 4CM (GLM915040, 30490129) WAS INSERTED FROM A SL-10 45° MICROCATHETER, STRYKER BUT THE COMPLAINT COIL BECAME STUCK ON THE WAY. IT WAS REMOVED TOGETHER WITH THE MICROCATHETER (MC) AND THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL WAS NOT DAMAGED IN ANY WAY. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL THE LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL HAS A DAMAGED CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12769937 ↗
• InjuryOct 19, 2021Entrapment of Device; Activation Problem; Entrapment of Device; Activation Problem

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, A 1.5MM X 4CM GALAXY G3 MINI COIL (GLM915040/L14219) BECAME STUCK IN THE CONCOMITANT HEADWAY 17 MICROCATHETER (MICROVENTION). THE COIL WAS PARTIALLY IN THE MICROCATHETER AND PARTIALLY PROTRUDING FROM THE DISTAL TIP AND THE COIL COULD NO LONGER BE ADVANCED OUT OF THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE COIL, BUT IT BECAME ENTANGLED WITH THE COIL (SIZE/BRAND/MANUFACTURER NOT SPECIFIED) THAT HAD BEEN IMPLANTED PRIOR TO THIS COIL AND THE COIL CAME OUT TO THE PARENT VESSEL. THEREFORE, THE PHYSICIAN IMPLANTED A STENT (BRAND/MANUFACTURER NOT SPECIFIED) TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON 30-SEP-2021 WAS REVIEWED. THE COIL THAT DEVIATED FROM THE MOTHER VESSEL WAS ONE OF SEVERAL COILS THAT HAD ALREADY BEEN PLACED. IT CANNOT BE IDENTIFIED BECAUSE OTHER COMPANIES' PRODUCTS HAD ALSO BEEN IMPLANTED. THE DEVIATED COIL WAS SECURED TO THE VESSEL WALL WITH ADDITIONAL STENT PLACEMENT. THE COMPLAINT COIL WAS RETRIEVED. SO FAR, THE PATIENT HAS HAD NO ADVERSE EVENTS DUE TO THE REPORTED EVENT. NO FURT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12655725 ↗
• MalfunctionSep 30, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, THIS WAS AN EMERGENT BRONCHIAL ARTERY EMBOLIZATION (BAE) FOR THE HAEMOPTYSIS PATIENT CAUSED BY ASPERGILLOSIS. A COMBINATION OF AN ANGIO CATHETER (5F) AND A MICROCATHETER (EXCELSIOR1018, STRYKER) WERE APPROACHED TO THE UPPER POSTERIOR INTERCOSTAL ARTERY. THE COMPLAINT COIL, A GALAXY G3 MINI 1.5MM X 4CM (GLM915040, 30429055) WAS INSERTED INTO THE MICROCATHETER TO EMBOLIZE THE SHUNT POINT. HOWEVER, THERE WAS AN INTENSIVE RESISTANCE FELT BETWEEN THE DELIVERY WIRE AND THE MICROCATHETER (MC). THE COIL PART WAS ABLE TO BE TAKEN IN AND OUT BUT IT WAS OUT OF CONTROL. IT WAS REPLACED WITH ANOTHER DEVICE (SAME CATALOG NUMBER) AND IT WAS IMPLANTED WITHOUT ANY PROBLEMS. AFTER THAT, AN IED COIL (2X8), TWO AZUR COILS (2X2) (2*4) AND THREE TARGET COILS (2X4) (2X4) (3X9) WERE USED AND HEMOSTASIS WAS ARCHIVED. SHUNT POINT EMBOLIZATION FROM THE INTERNAL THORACIC ARTERY STARTED WITH THE SAME SYSTEM. FOUR TARGET COILS AND SIX AZUR COILS WERE USED WITHOUT ANY PROBLEMS AND THE PROCEDURE COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THERE WAS NO REPORT THAT THE DEVICE APPEARED DAMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554168 ↗
• MalfunctionJul 9, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE BRONCHIAL ARTERIAL ANEURYSM, THE COMPLAINT COIL, A GALAXY G3 MINI 1.5MM X 4CM (GLM915040, L16061) WAS INSERTED FROM AN EXCELSIOR1018, STRYKER MICROCATHETER (MC)) WHICH APPROACHED THE BRANCH OF RIGHT BRONCHIAL ARTERY. THE COMPLAINT COIL ADVANCED APPROXIMATE 30CM BUT THERE WAS A RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER. THE COMPLAINT COIL WAS REPLACED WITH A GALAXY G3 MINI 1.5MM X 4CM (GLM915040, L16061 AND IT WAS ADVANCED SMOOTHLY. THE PROCEDURE CONTINUED AND AN IED COIL 1.5MMX3CM WAS ALSO IMPLANTED. THE BRANCH VESSEL WAS EMBOLIZED WITH TWO COILS. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINT PRODUCT WAS PACKED TOGETHER IN A SINGLE PACKAGE WITH THE SYSTEM AFTER DETACHMENT OF THE SECOND GALAXY MINI COIL. CONTINUOUS FLUSH ON THE MC WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE COMPLAINT DEVICE RECEIVED, THE EMBOLIC COIL WAS NOTED AS BEING STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146232 ↗
• InjuryMar 31, 2021Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A (B)(6)-YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF CORONARY ARTERY DISEASE (CAD), FOCAL NEUROLOGICAL DEFICITS, HEADACHES, PERIPHERAL VASCULAR DISEASE, HEADACHES, AND INTRACRANIAL ANEURYSM UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RECURRENT LEFT POSTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM ON (B)(6) 2020. THE TARGET ANEURYSM HAD BEEN PREVIOUSLY TREATED WITH UNSPECIFIED COILS ON (B)(6) 2019. 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2020 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIA: RESIDUAL ANEURYSM WITH CONTRAST WITHIN COIL INTERSTICES. MODIFIED RANKIN SCALE (MRS) SCORE WAS 1. RETREATMENT OF THE TARGET ANEURYSM WAS SUBSEQUENTLY PERFORMED DUE TO RESIDUAL ANEURYSM ON (B)(6) 2021. A 24CM COMPETITOR COIL WAS IMPLANTED WITH RAYMOND-ROY CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE ADVERSE EVENTS OR STUDY DEVICE DEFICIENCIES. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED AN UNRUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS: H

  Patient problems: Aneurysm

  MAUDE report 11594916 ↗
• MalfunctionFeb 10, 2021Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION BEFORE A TEVAR CASE, AN UNSPECIFIED MICROCATHETER (MC) WAS DELIVERED TO THE LESION AND SEVERAL COILS WERE USED. AFTER THAT, A 1.5MM X 4CM GALAXY G3 MINI COIL (GLM915040, L14820) WAS BEING DELIVERED BUT THERE WAS RESISTANCE FELT BETWEEN THE MICROCATHETER AND THE COMPLAINT COIL. THE COMPLAINT COIL BECAME KINKED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308842 ↗
• InjuryDec 21, 2020Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF WITH THE TARGET ANEURYSM AT THE MIDDLE CEREBRAL ARTERY (MCA), A 9FR SHEATH WAS INSERTED INTO THE RIGHT FEMORAL ARTERY. FROM THERE, THE PHYSICIAN USED THE 9FR BALLOON GUIDE CATHETER TO THE RIGHT INTERNAL CAROTID ARTERY (ICA). FROM THERE, THE PHYSICIAN DELIVERED A .072 NAVIEN¿ INTRACRANIAL SUPPORT CATHETER (MEDTRONIC) TO THE AREA BEYOND THE ICA SYPHON. A CONCOMITANT PROWLER SELECT PLUS MICROCATHETER WAS DELIVERED TO THE M2 SEGMENT OF THE MCA. THE PHYSICIAN WAS ABLE TO COVER THE ANEURYSM NECK ACCORDING TO PLAN WITH THE PULSERIDER T, 3MM, 8MM ARCH (201D / W3446-11), HOWEVER, IT WAS DIFFICULT TO DEPLOY THE PULSERIDER. NEXT, THE MICROCATHETER WAS INSERTED INTO THE ANEURYSM VIA THE TRANS-CELL APPROACH TECHNIQUE. TWO (B)(4) G3 COILS: A 3.5MM X 7.5CM; (B)(4) G3 ((B)(4)), A 2.5MM X 5CM; (B)(4) G3 XSFT ((B)(4)), AND TWO (B)(4) G3 MINI COILS: A 1.50MM X 3.00CM (B)(4) G3 MINI ((B)(4)), AND A 2.00MM X 3.00CM (B)(4) G3 MINI ((B)(4)) WERE IMPLANTED. THE 1.50MM X 4.00CM GALAXY G3 MINI COIL ((B)(4) / LOT# UNKNOWN) WAS INSERTED WITH THE PURPOSE OF PROVIDING ADDITIONAL EMBOLIZATION BECAUSE THERE WERE SPACES. IT WAS USE

  Patient problems: Aneurysm; Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 11052185 ↗
• MalfunctionOct 8, 2020Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, WHEN ATTEMPTING TO DELIVER A 1.5MM X 4CM GALAXY G3 MINI COIL (GLM915040, L16061), THE TIP OF THE COIL SHEATH PASSED THROUGH THE Y CONNECTOR, AND ATTACHED TO THE REAR END OF A EXCELSIOR SL-10, STRYKER MICROCATHER (MC). HOWEVER, THE COIL PART DID NOT COME OUT FROM THE DISTAL END OF THE COIL SHEATH. IT WAS PRESSED ¿A LITTLE STRONGLY¿, BUT THE DELIVERY WIRE PIERCED THE COIL SHEATH ,AND THE WIRE BROKE. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE DEVICE INVESTIGATION, THE EMBOLIC COIL WAS NOTED IN A STRETCHED CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10649045 ↗

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).