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GALAXY G3 GLM925035Recalls & reported problems

Cerenovus, Inc. · GALAXY G3 MINI Microcoil 9 Stretch Resistant Coil and Detachment System 190cm 2.5mm x 3.5cm GALAXY G3 MINI Stretch Resistant Coil and Detachment System · Class 2 · Implant

All models of GALAXY G3 (58)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
14
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886704080268), received between Nov 19, 2018 and Dec 9, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (4 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Deformation Due to Compressive Stress4
  • Failure to Advance4
  • Stretched3
  • Material Twisted/Bent2
  • Separation Failure2
  • Difficult or Delayed Separation1
  • Difficult to Advance1
  • Premature Activation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • Aneurysm4
  • No Consequences Or Impact To Patient4
  • Thromboembolism2

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 9, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 3MM X 4CM COIL (PRODUCT CODE: GLX120304, LOT NUMBER UNKNOWN) AND A GALAXY G3 MINI 2.5MM X 3.5CM COIL (PRODUCT CODE: GLM925035, LOT NUMBER UNKNOWN) KINKED INSIDE A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER UNKNOWN), WITH A NOTE THAT THE LUMEN WAS NOT COMPATIBLE. THE PRODUCTS INDICATED THAT BOTH COILS WERE KINKED OR BENT IN THE PATIENT AND IMPEDED, WHILE THE MICROCATHETER WAS OBSTRUCTED IN THE PATIENT WITHOUT LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR CONSEQUENCES, AND NO OBSERVABLE CLINICAL SYMPTOMS OR CHANGES IN THE PATIENT WERE IDENTIFIED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23758081 ↗
  • InjuryJun 8, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 52-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPOTHYROIDISM UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT MIDDLE CEREBRAL ARTERY (MCA) SIDE WALL ANEURYSM ON (B)(6) 2022. THE HUNT & HESS GRADE WAS 3, THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE TARGET ANEURYSM WAS AS FOLLOWS: HEIGHT 4.1MM, DOME 5.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.2MM, AND DOME-TO-NECK RATIO OF 2.3MM. THE PARENT VESSEL DIAMETER WAS 1.7MM. COIL EMBOLIZATION WAS PERFORMED USING THREE (3) CERENOVUS COILS: A 4MM X 7.5CM MICRUSFRAME 10 (MFR100407 / (B)(6)), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / (B)(6)), AND A 2MM X 2CM GALAXY G3 XSFT (GLX120202 / (B)(6)) VIA AN SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS DURING THE INDEX PROCEDURE. ON (B)(6) 2023, TH

    Patient problems: Aneurysm

    MAUDE report 17093085 ↗
  • MalfunctionFeb 25, 2022Failure to Advance; Failure to Advance

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING A LEFT VERTEBRAL ARTERY ANEURYSM, AFTER THE IMPLANTATION OF THE ENTERPRISE STENT, COIL EMBOLIZATION WAS PERFORMED USING THE JAILING TECHNIQUE. AFTER THE FOLLOWING COILS WERE IMPLANTED IN THE TARGET LESION IN THE FOLLOWING ORDER: ONE (1) 8MM X 33CM HYDROSOFT® COIL (MICROVENTION-TERUMO), ONE (2) 6MM X 20CM GALAXY G3 COIL, ONE 5MM X 15CM GALAXY G3 COIL, TWO (2) 4MM X 12CM HYDROSOFT® COIL (MICROVENTION-TERUMO), TWO (2) 3MM X 6CM HYDROSOFT® COIL (MICROVENTION-TERUMO), AND ONE (1) 2.5CM X 4.5MM GALAXY G3 MINI COIL, THE COMPLAINT PRODUCT, A 2.50MM X 3.50CM GALAXY G3 MINI COIL (GLM925035 / L16566) WAS SELECTED. THE COMPLAINT COIL WAS INSERTED INTO THE HEADWAY® DUO MICROCATHETER (MICROVENTION), BUT THERE WAS RESISTANCE FELT BETWEEN THE COMPLAINT PRODUCT AND THE HUB OF THE MICROCATHETER, AND WITHOUT ENTERING THE MICROCATHETER AT ALL. IT WAS REPORTED THAT NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE COMPLAINT DEVICE COULD NOT BE INSERTED INTO THE HUB OF THE MICROCATHETER. WHEN

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13603535 ↗
  • InjuryAug 25, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH NO REPORTED RELEVANT MEDICAL HISTORY UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.3MM, DOME 3.7MM, MAXIMUM ANEURYSM DIAMETER 4.5MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.4MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406 / K10045), ONE 3MM X 4CM GALAXY G3 MINI (GLM930040 / L17272), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / L15184), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / S15122), ONE 2MM X 3CM GALAXY G3 MINI (GLM920030 / L13933), AND ONE COMANECI STENT VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). INTRAOPERATIVELY A SEVERE THROMBOEMBOLIC EVENT OCCURRED. PER THE PRINCIPAL INVESTIGATOR THE EVENT WAS CONSIDERED SERIOUS HOWEVER NOT RELATED TO THE STUDY DEVICE. SURGICAL INTERVENTION OF A THROMBECTOMY AND AGGROSTAT MEDICATION ADMINISTRATION WAS REQ

    Patient problems: Aneurysm; Thromboembolism

    MAUDE report 12366437 ↗
  • InjuryAug 25, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH NO REPORTED RELEVANT MEDICAL HISTORY UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.3MM, DOME 3.7MM, MAXIMUM ANEURYSM DIAMETER 4.5MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.4MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406 / K10045), ONE 3MM X 4CM GALAXY G3 MINI (GLM930040 / L17272), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / L15184), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / S15122), ONE 2MM X 3CM GALAXY G3 MINI (GLM920030 / L13933), AND ONE COMANECI STENT VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). INTRAOPERATIVELY A SEVERE THROMBOEMBOLIC EVENT OCCURRED. PER THE PRINCIPAL INVESTIGATOR THE EVENT WAS CONSIDERED SERIOUS HOWEVER NOT RELATED TO THE STUDY DEVICE. SURGICAL INTERVENTION OF A THROMBECTOMY AND AGGROSTAT MEDICATION ADMINISTRATION WAS REQ

    Patient problems: Aneurysm; Thromboembolism

    MAUDE report 12366415 ↗
  • MalfunctionJun 1, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

    THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2.50MM X 3.50CM GALAXY G3 MINI COIL (GLM925035 / 30375969) WAS THE FIRST COIL USED; THE COIL COULD NOT BE ADVANCED NOR RETRACTED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, IT WAS NOTED THAT THE COIL WAS IN STRETCHED CONDITION. ANOTHER 2.50MM X 3.50CM GALAXY G3 MINI COIL WAS USED AS A REPLACEMENT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT NOR ANY PATIENT COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11917002 ↗
  • MalfunctionMay 18, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT INTERNAL CAROTID ARTERY, THE COMPLAINT, A GALAXY G3 MINI 2.5MM X 3.5CM (GLM925035, L16643) WAS INSERTED INTO THE MICROCATHETERS BUT THERE WAS A RESISTANCE FELT. THE COIL WAS RETRACTED AND IT WAS UNRAVELED. IT WAS REPLACED WITH A GALAXY G3 2X3 MINI) AND IT WAS IMPLANTED INSIDE THE ANEURYSM WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY REPORTED. INITIALLY, TWO MICROCATHETERS (SL10, STRYKER) (PHENOM, MEDTORNIC) WERE USED AS A DOUBLE CATHETER TECHNIQUE. A TARGET 360 SOFT COIL (4X8) WAS INSERTED FROM THE SL10 AND A G3XSFT COIL (3X6) WAS INSERTED FROM THE PHENOM TO MAKE FRAMING. THE COIL AT THE SL10 KEPT USED WITHOUT BEING CUT AND THREE COILS (GALAXY G3 3X4 MINI) (2-3X4 IED) (GALAXY G3 2.5X3.5 MINI) WERE USED FOR FILLING. TWO COILS, AN UNSPECIFIED 2X2 COIL AND A 1.5X2 PRIME COIL WERE USED AS FINISHING COILS AND THE PROCEDURE WAS COMPLETED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11841068 ↗
  • MalfunctionDec 31, 2020Failure to Advance; Failure to Advance

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM), AFTER THE ISSUE ENCOUNTERED WITH THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / (B)(4)), THE 2.50MM X 3.50CM GALAXY G3 MINI COIL (GLM925035 / L13097) WAS USE WITH THE SL-10® MICROCATHETER (STRYKER). THE PHYSICIAN FELT RESISTANCE WHEN THE COIL WAS INTRODUCED INTO THE MICROCATHETER. THE RESISTANCE WAS FELT AT THE PROXIMAL END OF THE MICROCATHETER. THE COIL WAS IMMEDIATELY PULLED, AND A DIFFERENT BRAND OF COILS WERE USED. IT WAS REPORTED THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WAS NO KINK OR DAMAGE ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE ISSUE REPORTED. THE MICROCATHETER WAS PROPERLY FLUSHED AND DELIVERED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORT OF ANY BLOOD FLOW RESTRICTION OR REDUCTION AS A RESULT OF THE ISSUE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING STRYKER COILS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11102355 ↗
  • InjuryDec 16, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE (B)(6)-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEADACHES, HYPERLIPIDAEMIA (CONTROLLED), HYPERTENSION (10 YEARS HISTORY, CONTROLLED), AND OBESITY (BMI 30 KG/M2) PRESENTED WITH A SUBARACHNOID HEMORRHAGE SECONDARY TO THE TARGET RUPTURED ANEURYSM LOCATED ON THE ANTERIOR CIRCULATION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA); HUNT & HESS GRADE 1. THE PATIENT SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED ANEURYSM ON THE RIGHT BIFURCATION OF THE MCA WITH THE FOLLOWING DIMENSIONS: HEIGHT: 2.5MM, DOME: 3.0MM, DIAMETER: 5.0MM, NECK SIZE 3.0MM, AND DONE TO NECK RATIO: 1MM. THE PARENT VESSEL DIAMETER WAS 2.5.MM. THE COIL EMBOLIZATION PROCEDURE WAS PERFORMED WITH THE IMPLANTATION THE FOLLOWING COILS: ONE 2.50MM X 3.50CM (B)(4) G3 MINI ((B)(4) / L12395), ONE 1.50MM X 2.00CM (B)(4) G3 MINI ((B)(4) / L12474), ONE 2.00MM X 4.00CM (B)(4) G3 MINI ((B)(4) / L14221), ONE 1.00MM X 3.00CM (B)(4) G3 MINI ((B)(4) / L12231), TWO 1.00MM X 2.00CM (B)(4) G3 MINI ((B)(4)) FROM THE SAME LOT (L14420), AND ONE 1.00MM X 1.00CM GALAXY G3 MINI ((B)(4) / L14466) VIA THE CONCOMITANT SL-10® MICROCATHETE

    Patient problems: Aneurysm

    MAUDE report 11016741 ↗
  • MalfunctionDec 11, 2020Material Twisted/Bent; Material Twisted/Bent

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF RUPTURED ANEURYSM THE RIGHT VERTEBRAL ARTERY, TWO MINI COILS (2.5 X 3.5) AND (2.5 X 3.5) WERE INSERTED INTO PHENOM 17, MEDTORNIC MICROCATHETER (MC). AFTER THAT, THE COMPLAINT COIL, A 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035, L14134) WAS USED. THE INTRODUCER OF THE COMPLAINT COIL WAS PRESSED AGAINST THE HUB OF THE CONCOMITANT MICROCATHETER BUT THE COIL WINDED BECAUSE THERE WAS A SLIGHT GAP BETWEEN THE SHEATH AND THE HUB. IT WAS NOT ABLE TO BE INSERTED INTO THE MICROCATHETER. ANOTHER SAME SIZED COIL WAS INSERTED INTO IT AND IT WAS ABLE TO CROSS THE HUB PART. AFTER THAT, TWO COILS (2 X 3) AND (1.5 X 4) EMBOLIZED THE LESION. A COIL (1 X 4) WAS ALSO ATTEMPTED TO BE USED BUT DID NOT FIT THE LESION BECAUSE OF THE COIL MASS. THE PROCEDURE WAS COMPLETED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE VISUAL ANALYSIS OF THE PHOTO RECEIVED, THE EMBOLIC COIL WAS NOTED KINKED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10991127 ↗
  • MalfunctionMay 21, 2020Stretched; Stretched

    THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2.50MM X 3.50CM GALAXY G3 MINI COIL (GLM925035 / L16922) FAILED TO BE RE-ZIPPED / RE-SHEATHED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. 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 FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS 5/21/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10081009 ↗
  • MalfunctionDec 23, 2019Separation Failure; Separation Failure

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED ANEURYSM, THE 2.5MM X 3.5CM GALAXY G3 MINI COIL (GLM925035 / L14574) AND THE ENPOWER CONTROL CABLE (ECB00018200 / S14674) WERE CONNECTED AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. THE BUTTON WAS PRESSED FIVE TIMES, BUT THE COIL COULD NOT BE DETACHED. THE COIL AND THE CONTROL CABLE WERE REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9511523 ↗
  • MalfunctionDec 17, 2018Premature Activation; Premature Activation

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A VERTEBRAL ARTERY ANEURYSM, THE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035/L11014) THERMO-MECHANICAL COIL WAS SELECTED FOR USE AS THE FIFTEENTH COIL, BUT RESISTANCE WAS ENCOUNTERED BETWEEN THE COIL AND THE CONCOMITANT SL-10 (STRYKER) MICROCATHETER AT APPROXIMATELY THE ¿AO¿. THE DISTAL END OF THE COIL DEPLOYED FROM THE MICROCATHETER, BUT THE PHYSICIAN STOPPED DELIVERY OF THE COIL. THE COIL WAS REPLACED WITH A COMPETITOR DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WAS DISCARDED AND IS THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8171272 ↗
  • MalfunctionNov 19, 2018Separation Failure; Difficult or Delayed Separation; Separation Failure; Difficult or Delayed Separation

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE GALAXY G3 MINI 2.5MM X 3.5CM COIL (GLM925035 / L12395) WAS COMPLETELY ADVANCED INTO THE ANEURYSM AND THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH THE COIL USING DIFFERENT POSITIONING STRATEGIES. THE GALAXY G3 MINI COIL EVENTUALLY DETACHED AND WAS IMPLANTED IN THE ANEURYSM AFTER AN APPROXIMATELY 7 ATTEMPTS WERE MADE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8087077 ↗

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).

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