GALAXY G3 GLM915030Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10886704080145), received between Nov 14, 2018 and May 13, 2026 — classified as 17 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (11 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A GALAXY G3 MINI 2MM X 3CM (GLM920030/ 1832511S), GALAXY G3 MINI 2MM X 6CM (GLM920060/ 1832524S), AND A GALAXY G3 MINI 1.5MM X 3CM (GLM915030/ 1612501S) WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED ZIPPING DIFFICULTY & IMPEDED IN MICROCATHETER. THE EVENT WAS REPORTED AS SUCH, ¿ZIPPING DIFFICULTY & IMPEDED IN MICROCATHETER. IT WAS REPORTED THAT DURING PROCEDURE, COIL MICROCATHETER WAS IN PLACE, THEN DELIVERED COIL. DURING PROCESS OF DELIVERING THE COIL, COIL MICROCATHETER (OTHER BRAND) MIGRATED OUT OF THE ANEURYSM. THE DOCTOR ONLY RETRACTED THE COIL ALONE FOR ADJUSTMENT, BUT THE COIL COULD NOT BE RETRACTED TO THE INTRODUCER SHEATH. THE DOCTOR REMOVED THE COIL AND SWITCHED A SECOND COIL, THE SECOND COIL WAS IMPEDED IN THE PROXIMAL END OF THE COIL MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE SECOND COIL ALONE, BUT IT ALSO COULD NOT BE RETRACTED TO THE INTRODUCER SHEATH. THE DOCTOR REMOVED THE SECOND COIL AND COIL MICROCATHETER, THEN SWITCHED A SECOND COIL MICROCATHETER (OTHER BRAND) TO DELIVER A THIRD COIL. THE THIRD COIL WAS PACKED AND DETACHED IN THE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158944 ↗
• MalfunctionNov 26, 2025Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, WHEN FILLING THE TARGET SITE WITH COILS, IT WAS FOUND THAT THE COIL, A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 0442502S) WAS UNABLE TO ROTATE RANDOMLY AND THE SHAPE OF THE COIL WAS NOT IDEAL. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A SECOND COIL, A 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 1502509S) AND A THIRD COIL, 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 1112514S) SUCCESSIVELY. THE SECOND AND THE THIRD COIL HAD THE SAME ISSUE AS THE FIRST COIL. THE PHYSICIAN RETRACTED THE COILS AND EVENTUALLY REPLACED IT WITH A FOURTH COIL (UNSPECIFIED COMPETITOR BRAND) TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661060 ↗
• MalfunctionDec 4, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, 30901465) BECAME STRETCHED IN THE ANEURYSM WHEN IT WAS PUSHED AND PULLED BETWEEN AN UNSPECIFIED STENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843691 ↗
• MalfunctionJun 27, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL, A 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 30889332) WAS MEANT TO BE INSPECTED IN SODIUM CHLORIDE SOLUTION, BUT THERE WAS RESISTANCE WHEN THE COIL WAS BEING PUSHED OUT OF THE INTRODUCER SHEATH. THE COIL FAILED TO EXIT THE INTRODUCER SHEATH. ON 10-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE INTRODUCER. CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 27-JUN-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 19626150 ↗
• MalfunctionJun 3, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AFTER DETACHING TWO COILS SUCCESSFULLY IN THE ANEURYSM. THE THIRD COIL, A GALAXY G3 MINI 1.5MM X 3CM (GLM915030, 30937887) FILLED IN THE ANEURYSM AND TRIED TO BE DETACHED, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN INSPECTED INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECTED CABLE, AND OBSERVED ALL WERE UNDER GOOD CONDITION. THE PHYSICIAN RETRACTED THE COIL OUT OF THE PATIENT AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 31-MAY-2024 INDICATED THAT THE SAME DETACHABLE CONTROL BOX (DCB) AND SAME CABLE WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447314 ↗
• MalfunctionApr 24, 2024Stretched; Separation Failure; Stretched; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE FIRST COIL WAS FILLED IN THE ANEURYSM AND WAS DETACHED SUCCESSFULLY, BUT THE SECOND COIL, A GALAXY G3 MINI 1.5MM X 3CM (GLM915030, 30937887) WAS UNABLE TO BE DETACHED. THE PHYSICIAN SWITCHED TO A NEW DETACHMENT BOX AND THEN PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO BE DETACHED. THEN THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO NEW ONE TO COMPLETE THE SURGERY. DURING THE SURGERY, THE PHYSICIAN INSPECTED INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECT CABLE, AND OBSERVED ALL WERE IN GOOD CONDITION. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED DURING THE SURGERY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173006 ↗
• MalfunctionMar 25, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 30889334) DID NOT DETACH. THE COIL WAS ¿POSITIONED PERFECTLY WITHIN THE ANEURYSM AND OTHER COILS. [THE] COIL COULD NOT BE DETACHED AND HAD TO BE REMOVED FROM [THE] PATIENT.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18975914 ↗
• MalfunctionFeb 5, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, 30896004) WAS FILLED IN ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641194 ↗
• MalfunctionJan 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 30895994) 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 18509176 ↗
• MalfunctionJan 10, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, 30896000) BECAME IMPEDED IN INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO A NON J&J MICROCATHETER (MC). THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE, A GALAXY G3 MINI 3MM X 8CM (GLM930080, 30865692) BUT THE SAME ISSUE OCCURRED. THE DOCTOR CHANGED THE THIRD COIL TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-NOV-2023 INDICATED THAT THE COILS WERE IMPEDED IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO THE MICROCATHETER. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484634 ↗
• MalfunctionNov 9, 2023Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, 30895998) WAS JUST DELIVERED INTO THE UNSPECIFIED MICROCATHETER (MC), THE DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER SHEATH PREMATURELY. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE, A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, 30895998) BUT THE SAME ISSUE OCCURRED. THE DOCTOR WITHDREW THE SECOND COIL AND CHANGED TO A THIRD ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 06-NOV-2023 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED ON THE DEVICES. THE DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER SHEATH PREMATURELY. THERE HAD NOT BEEN ANY ATTEMPTS TO DETACH THE COIL PRIOR TO THE PREMATURE DETACHMENT. THE COILS DID NOT PREMATURELY DETACH, BUT RATHER PREMATURELY SEPARATED FROM THE INTRODUCER SHEATH. NO ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE COILS. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103926 ↗
• MalfunctionNov 9, 2023Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, 30895998) WAS JUST DELIVERED INTO THE UNSPECIFIED MICROCATHETER (MC), THE DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER SHEATH PREMATURELY. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE, A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, 30895998) BUT THE SAME ISSUE OCCURRED. THE DOCTOR WITHDREW THE SECOND COIL AND CHANGED TO A THIRD ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 06-NOV-2023 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED ON THE DEVICES. THE DELIVERY WIRE OF THE COIL WAS FOUND TO BE SEPARATED FROM THE INTRODUCER SHEATH PREMATURELY. THERE HAD NOT BEEN ANY ATTEMPTS TO DETACH THE COIL PRIOR TO THE PREMATURE DETACHMENT. THE COILS DID NOT PREMATURELY DETACH, BUT RATHER PREMATURELY SEPARATED FROM THE INTRODUCER SHEATH. NO ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE COILS. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103919 ↗
• MalfunctionJul 24, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 30889334) COULD NOT BE DETACHED AND HAD TO BE REMOVED FROM THE PATIENT. THE DETACHMENT CABLE WAS WORKING FINE WITH OTHER COILS USED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379990 ↗
• MalfunctionApr 4, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE SECOND COIL, A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0304 / 30810800) AND THE FOURTH COIL, A 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 30722167) COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. IT WAS REPORTED THAT THE PHYSICIAN USED THE ¿SAME LIKE¿ PRODUCTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679053 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY (B)(4), A 46-YEAR-OLD FEMALE PATIENT (B)(6) WITH A HISTORY OF HYPERTENSION (CONTROLLED), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY (PCA) SIDE WALL ANEURYSM WITH HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 4.5MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 3.3MM, NECK SIZE 2.1MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PER CRF AND CLINICAL DATABASE, COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: A 3.5MM X 6CM MICRUSFRAME S (L16863), A GALAXY G3 XTRASOFT 3MM X 4CM (GLX120304/L16554), A 2MM X 3CM GALAXY G3 MINI (GLM920030/L30546463), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30546460), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30393176), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/ 30490127) AND A 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/30390770) VIA AN EXCELSIOR SL-10 0165 45 TIP 150 CM MICROCATHETER. HEPARIN HAS BEEN ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE

  Patient problems: Aneurysm

  MAUDE report 16194878 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY (B)(4), A 46-YEAR-OLD FEMALE PATIENT (B)(6) WITH A HISTORY OF HYPERTENSION (CONTROLLED), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY (PCA) SIDE WALL ANEURYSM WITH HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 4.5MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 3.3MM, NECK SIZE 2.1MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PER CRF AND CLINICAL DATABASE, COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: A 3.5MM X 6CM MICRUSFRAME S (L16863), A GALAXY G3 XTRASOFT 3MM X 4CM (GLX120304/L16554), A 2MM X 3CM GALAXY G3 MINI (GLM920030/L30546463), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30546460), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30393176), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/ 30490127) AND A 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/30390770) VIA AN EXCELSIOR SL-10 0165 45 TIP 150 CM MICROCATHETER. HEPARIN HAS BEEN ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE

  Patient problems: Aneurysm

  MAUDE report 16194874 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY (CNV_2017_01), A 46-YEAR-OLD FEMALE PATIENT (B)(6) WITH A HISTORY OF HYPERTENSION (CONTROLLED), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY (PCA) SIDE WALL ANEURYSM WITH HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 4.5MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 3.3MM, NECK SIZE 2.1MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PER CRF AND CLINICAL DATABASE, COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: A 3.5MM X 6CM MICRUSFRAME S (L16863), A GALAXY G3 XTRASOFT 3MM X 4CM (GLX120304/L16554), A 2MM X 3CM GALAXY G3 MINI (GLM920030/L30546463), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30546460), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30393176), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/ 30490127) AND A 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/30390770) VIA AN EXCELSIOR SL-10 0165 45 TIP 150 CM MICROCATHETER. HEPARIN HAS BEEN ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE,

  Patient problems: Aneurysm

  MAUDE report 16194866 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 29-YEAR-OLD MALE PATIENT (SUBJECT (B)(6) WITH NO RELEVANT MEDICAL HISTORY, UNDERWENT COIL EMBOLIZATION OF A RUPTURED, SIDE WALL, RIGHT ANTERIOR CHOROIDAL ARTERY (ACHA) ANEURYSM WITH A HUNT & HESS GRADE 3, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 3.2MM, DOME 1.8MM, MAXIMUM ANEURYSM DIAMETER 1.9MM, NECK SIZE 1.3MM, AND DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 0.6MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PER THE CASE REPORT FORM (CRF) AND THE CLINICAL STUDY DATABASE, THE COIL EMBOLIZATION WAS PERFORMED WITH A 1.50MM X 3.00CM GALAXY G3 MINI COIL (GLM915030 / L14712) VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE PRINCIPAL INVESTIGATOR (PI), THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE. THE STUDY COIL WAS SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH A PACKING DENSITY WITHOUT G3 MINI COIL (USING ANGIOSUITE) WAS 0% AND AT THE CONCLUSION OF THE PROCEDURE (USING ANGIOSUITE) WAS 21%. A BALLOON CATHETER (UNSPECIFIED BRAND) WAS ALSO USED. IMMEDIATE POST-PROCEDURE MOD

  Patient problems: Aneurysm

  MAUDE report 16185657 ↗
• 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 15714171 ↗
• 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 15714167 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 68-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE SACCULAR ANEURYSM AT THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 5.5MM, DOME 8.4MM, MAXIMUM ANEURYSM DIAMETER 8.4MM, NECK SIZE 4.3MM, AND THE DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.8MM. COIL EMBOLIZATION WAS PERFORMED WITH A TOTAL OF TEN (10) COILS. THE FOLLOWING SIX (6) CERENOVUS COILS WERE IMPLANTED: ONE 7MM X 21CM GALAXY G3 (GLY120721 / L15699), ONE 6MM X 15CM GALAXY G3 (GLY120615 / L13589), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L13315), ONE 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / L13521), ONE 3MM X 6CM GALAXY G3 MINI (GLM930060 / L13936) AND ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / L13672). IN ADDITION, FOUR (4) 2MM X 3CM TARGET® 360 NANO¿ COIL (STRYKER) WERE ALSO IMPLANTED. ALL COILS WERE DELIVERED VIA THE HEADWAY® 17 MICROCATHETER (MICROVENTION). A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED. THERE WAS NO INTRA-OPERATIVE ANEURYSM RUPTURE

  Patient problems: Ischemia Stroke

  MAUDE report 15547316 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 66-YEAR-OLD FEMALE PATIENT WHO IS A CURRENT SMOKER WITH A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CONTROLLED HYPERTENSION, AND CONTROLLED HYPERLIPIDAEMIA UNDERWENT COIL EMBOLIZATION OF A LEFT-SIDED RUPTURED ANEURYSM IN THE BIFURCATION OF THE MIDDLE CEREBRAL ARTERY (MCA) WITH A MODIFIED RANKIN SCALE (MRS) SCORE 0 AND HUNT & HESS GRADE OF 3 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 5.0MM, DOME 2.4MM, MAXIMUM ANEURYSM DIAMETER 5.0MM, NECK SIZE 2.0MM, AND THE DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.8MM. COIL EMBOLIZATION WAS PERFORMED WITH AN UNKNOWN COIL. THE COIL WAS IMPLANTED VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). A BALLOON CATHETER (UNSPECIFIED BRAND) WAS ALSO USED. DURING THE PROCEDURE, THE PATIENT EXPERIENCED AN INTRA-OPERATIVE THROMBOEMBOLIC EVENT, WHICH WAS TREATED WITH MEDICATION. THE PATIENT WAS ASYMPTOMATIC (ONLY OBSERVED ANGIOGRAPHICALLY). THERE WAS NO REPORTED DEVICE DEFICIENCY. ON (B)(6) 2022, THE PATIENT EXPERIENCED AN INTRA-OPERATIVE THROMBOLIC EVENT AT THE POSTERIOR COMMUNICATING ARTERY (PCOM), INTRA-PROCEDURAL ANEURYSM PERFORATION, AND AN INTRA

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15328556 ↗
• MalfunctionApr 11, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, 30624672) WAS BEING USED AS A FIRST 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 WAS NOTED TO BEING 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 14073577 ↗
• MalfunctionApr 7, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE PHYSICIAN WAS NOT ABLE TO INSERT A GALAXY G3 MINI 1.5MM X 2.5CM COIL (GLM915025, S15171) OR A GALAXY G3 MINI 1.5MM X 3CM COIL (GLM915030, L11005) INTO THE HUB OF ECHELON14 (14/105-5092-150) TIP STRAIGHT MICROCATHETER (MEDTRONIC). THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS DELAYED BY 15 MINUTES OR MORE DUE TO THE EVENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE HAD BEEN NO EXCESSIVE FORCE APPLIED TO THE DEVICES. IT WAS NO NECESSARY TO REMOVE CONCOMITANT DEVICES WITH THE COMPLAINT DEVICE. THERE WERE NO DEVICE FRAGMENTS THAT REMAINED IN THE PATIENT. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. A TARGET AND AXIUM COILS (WITH BIGGER DIAMETER) WERE USED SUCCESSFULLY WITH THE SAME MICROCATHETER (MC). THE EVENTS DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MC WAS NOT DAMAGED DURING MANIPULATION OF THE COILS OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. NOTHING WAS NOTED TO BE OBSTRUCTING THE MC. THE INTRODUCER WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043246 ↗
• MalfunctionMar 14, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE EVENT WAS REPORTED VIA THE STERLING STUDY. A 79-YEAR-OLD FEMALE PATIENT UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON (B)(6) 2021. COIL EMBOLIZATION WAS PERFORMED. A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / 30392736) WAS USED BUT IT WAS NOT IMPLANTED DUE TO COIL MIGRATION. THE EMBOLIZATION CONTINUED WITH THE IMPLANTATION OF A 2.50MM X 4.50CM GALAXY G3 MINI (GLM925045 / 30393182). WHEN A 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 30383045) WAS CHOSEN, THE COIL WAS ALSO NOT IMPLANTED DUE TO MIGRATION. THIS COIL WAS FOLLOWED BY A 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30466099) WHICH WAS ALSO NOT USED BECAUSE THE COIL MIGRATED. THE PROCEDURE CONTINUED WITH THE IMPLANTATION OF STRYKER COILS IN THE FOLLOWING ORDER: TWO (2) 1MM X 3CM TARGET 360 NANO COILS, TWO (2) 1MM X 2CM TARGET 360 NANO COILS, AND A AND A 1MM X 3CM TARGET 360 NANO COIL. THE REPORTED COIL MIGRATION ISSUE DID NOT RESULT IN ADVERSE EVENT OR PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759660 ↗

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).