GALAXY G3 GLM930040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704080329), received between Jul 13, 2018 and May 5, 2022 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET ON THE INTERNAL CAROTID ARTERY (ICA), THE PHYSICIAN TRIED TO RESHEATH AFTER DECIDING THAT THE COMPLAINT COIL, A 3.00MM X 4.00CM GALAXY G3 MINI (GLM930040 / 30393183) DUE TO AN ¿IMPROPER¿ CHOICE DURING THE PROCEDURE, BUT THE DEVICE FAILED TO BE RESHEATHED AND THE INTRODUCER WAS SPLIT. THERE WAS NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COMPLAINT COIL THROUGH THE MICROCATHETER; IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER FROM THE TARGET. IT WAS REPORTED THAT THERE WAS NO PROCEDURE DELAY AS A RESULT OF THE REPORTED ISSUE; THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. DURING THE MICROSCOPIC INSPECTION, THE COIL WAS OBSERVED TO BE IN A STRETCHED CONDITION. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 04-MAY-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292707 ↗
• MalfunctionDec 6, 2021Fracture; Difficult to Advance; Fracture; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE TARGET LESION WAS ACCESS WITH A GUIDING CATHETER, INTERMEDIATE CATHETER AND A MICROCATHETER. THE 3.00MM X 4.00CM GALAXY G3 MINI COIL (GLM930040 / L15549) WAS SELECTED AFTER THE 5MM X 20CM TARGET 360 SOFT COIL (STRYKER) AND A 4MM X 8CM AXIUM PRIME 3D COIL (MEDTRONIC). WHEN THE COMPLAINT COIL WAS INSERTED IN THE SL-10® MICROCATHETER (STRYKER) AS PER THE INSTRUCTIONS FOR USE (IFU), THERE WAS STRONG RESISTANCE FELT BETWEEN THE COIL AND THE MICROCATHETER ALONG THE WAY. WHEN THE COIL WAS REMOVED, THE DELIVERY WIRE IN FRONT OF THE COIL JOINT WAS DISTORTED AND THE POLYETHYLENE PART WAS TORN OFF. THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT BODY. THE 3MM X 4CM AXIUM PRIME 3D COIL WAS INSERTED AND THERE WAS NO RESISTANCE AT ALL; IT WAS DELIVERED TO THE TARGET LESION AND DETACHED. NEXT, THE PHYSICIAN INSERTED A 2MM X 3CM TARGET 360 NANO COIL WHICH ALSO DID NOT ENCOUNTER ANY RESISTANCE AND WAS DELIVERED TO THE TARGET LESION AND DETACHED. THE PROCEDURE WAS THEN COMPLETED. IT WAS REPORTED THAT THERE WAS CONTINUOUS FLUSH THROUGH THE CONCOMITANT MICROCATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934041 ↗
• InjuryAug 25, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A (B)(6) 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 REQUIRED A

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 12366403 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A MALE PATIENT UNDERWENT A PULSERIDER-ASSISTED COIL EMBOLIZATION OF A BASILAR ARTERY ANEURYSM AND EXPERIENCED INTRAOPERATIVE ANEURYSM RUPTURE. THE PULSERIDER T 10MM ARCH, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / 3051697708) WAS DEPLOYED AT THE TARGET ANEURYSM, AND COIL EMBOLIZATION WAS STARTED. A 5MM X 15CM GALAXY G3 COIL WAS USED TO FRAME THE ANEURYSM AND TWO GALAXY G3 XSFT (4MM X 10CM & 4MM X 6CM) WERE USED AS FILLING COILS. A 3MM X 4CM GALAXY G3 MINI (GLM930040 / L13708) WAS ALLEGEDLY USED AS PER THE INSTRUCTIONS FOR USE (IFU) AS THE FOURTH COIL, BUT BLEEDING WAS CONFIRMED FROM A BLEB ABOVE THE ANEURYSM. A TOTAL OF NINE GALAXY G3 MINI COILS WERE SUBSEQUENTLY IMPLANTED FOR HEMOSTASIS. ANGIOGRAPHY SHOWED NO FURTHER BLEEDING FROM THE BLEB. AFTER COILING WAS COMPLETED, THE PHYSICIAN ATTEMPTED TO DETACH THE PULSERIDER ANRD IMPLANT, BUT THE ANCILLARY DETACHMENT CONTROLLER (PRODUCT CODE & LOT NUMBER UNKNOWN) DISPLAYED AN ERROR. THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH THE DEVICE, BUT A FLASHING RED LIGHT DISPLAYED ON THE CONTROLLER. THE PULSERIDER ACCESSORY CABLE (PRDSACD / 30393940) WAS REPLACED, BUT THE SAME ISSUE CON

  Patient problems: Aneurysm

  MAUDE report 12212281 ↗
• MalfunctionJan 27, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET LESION ON THE M1 SEGMENT, THERE WERE SEVERAL ATTEMPTS TO DETACH THE 3.00MM X 4.00CM GALAXY G3 MINI COIL (GLM930040 / L14417) USING THE ENPOWER DETACHMENT CONTROL BOX (DCB) AND THE ENPOWER CONTROL CABLE, BUT THE COIL WAS NOT DETACHING. ADDITIONAL INFORMATION PROVIDED CONFIRMED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED, THE LOW BATTERY LIGHT WAS NOT SEEN, ALL THE LIGHTS ILLUMINATED WHEN THE POWER BUTTON WAS PRESSED, THE SYSTEM READY LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEP WAS HEARD DURING THE ATTEMPTS TO DETACH THE COIL. THE COIL WAS THEN WITHDRAWN INTO THE CONCOMITANT MICROCATHETER AND REMOVED. IT WAS REPORTED THAT THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED; IT WAS NOT STRETCHED WHEN IT WAS REMOVED. ANOTHER 3.00MM X 4.00CM GALAXY G3 MINI COIL WAS USED TO REPLACE THE COMPLAINT COIL AND WAS SUCCESSFULLY USED WITH THE SAME ENPOWER DCB AND ENPOWER CONTROL CABLE. THE REPORTED COIL DETACHMENT ISSUE DID NOT RESULT IN ANY DELAY IN THE PROCEDURE; IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240871 ↗
• MalfunctionDec 8, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 3.00MM X 4.00CM GALAXY G3 MINI COIL (GLM930040 / L17188) WAS THE FINISHING COIL. WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE BEEPING WAS HEARD AS NORMAL, BUT DURING THE ATTEMPT TO RETRIEVE THE DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT AND THE COIL FAILED TO DETACH. THE PHYSICIAN USED ANOTHER 3.00MM X 4.00CM GALAXY G3 MINI COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10969432 ↗
• InjuryOct 23, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, THE (B)(6) FEMALE PATIENT WITH A HISTORY OF HYDROCEPHALUS PRESENTED WITH A SUBARACHNOID HEMORRHAGE (HUNT & HESS GRADE 2) AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION OF A RUPTURED POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ANEURYSM ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A LEFT PICA BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.0MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 5.0MM, NECK SIZE 2.3MM, AND DOME-TO-NECK RATIO 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.0MM. THE PATIENT SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION AND THE FOLLOWING COILS WERE DELIVERED AND IMPLANTED VIA THE PHENOM¿ 17 MICROCATHETER (MEDTRONIC): ONE 3MM X 4CM GALAXY G3 MINI (GLM930040 / L12914), ONE 2MM X 6CM GALAXY G3 MINI (GLM920060 / L11063), AND ONE 1MM X 4CM GALAXY G3 MINI (GLM910040 / L11000). IN THE OPINION OF THE INVESTIGATOR, THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH ANGIOSUITE PACKING DENSITY 24%. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS IIIA: RESIDUAL ANEURYSM WITH CONTRAST WITHIN COIL INTERSTICES. THE

  Patient problems: Aneurysm; No Code Available

  MAUDE report 10729232 ↗
• MalfunctionAug 9, 2019Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE INSERTION OF A 3MM X 4CM GALAXY G3 (GLM930040, L14078) INTO A MICROCATHETER, THE PHYSICIAN NOTICED THE ISSUE OF THE FLUORO-SAVER MARKER (OUT OF POSITION). UNDER THE JUDGMENT OF THE PHYSICIAN, THE COIL WAS IMPLANTED WITHOUT ANY PROBLEMS AND IT WAS DETACHED. THE DPU WAS REMOVED FROM THE PATIENT¿S BODY, AND THE PROCEDURE WAS COMPLETED. THERE WAS ALSO NO PATIENT INJURY REPORTED. THE USER DID NOT APPLY EXCESSIVE FORCE DURING UNSHEATHING OR RE-SHEATHING OF THE DEVICE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE DEVICE WAS DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR SUE (IFU). NO FURTHER INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE PRELIMINARY PICTURES RECEIVED, THE FLOURO SAVER MARKER IS TOO PROXIMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8880988 ↗
• MalfunctionMar 26, 2019Entrapment of Device; Migration; Entrapment of Device; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM, AFTER THE 2 MM X 6 CM GALAXY G3 MINI COIL (GLM920060 / L12685) WAS INSERTED AND FAILED TO DETACH, THE PHYSICIAN DECIDED TO WITHDRAW THIS COIL WHEN IT BECAME ENTANGLED WITH ONE OF THE PREVIOUSLY IMPLANTED COILS, A 3 MM X 4 CM GALAXY G3 MINI COIL (GLM930040 / L14305). AS A RESULT, THE COILS CAME OUT TOGETHER. THE COIL WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER INCIDENT OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS REPORTED THAT THE PRODUCT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453256 ↗
• MalfunctionMar 25, 2019Material Twisted/Bent; Component Misassembled; Material Twisted/Bent; Component Misassembled

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® NANO 360 (STRYKER). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. PRELIMINARY PHOTO IMAGES OF THE COMPLAINT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448510 ↗
• MalfunctionDec 12, 2018Stretched; Material Deformation; Material Twisted/Bent; Stretched; Material Deformation; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BASILAR ARTERY SUPERIOR CEREBELLAR ARTERY (BASCA) ANEURYSM, STRONG RESISTANCE WAS ENCOUNTERED BETWEEN THE 3MM X 4CM GALAXY G3 MINI (GLM930040/L13708) THERMO-MECHANICAL COIL AND SL-10 (STRYKER) MICROCATHETER AS THE COIL WAS ATTEMPTED TO BE INSERTED INTO THE MICROCATHETER. THE COIL WAS REMOVED FROM THE SHEATH AND VISUALLY INSPECTED, AND AN ABNORMALITY OF THE COIL LOOP WAS OBSERVED. THE DAMAGED COIL WAS REPLACED WITH A SAME-SIZED COIL 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. AN ENPOWER DCB2 DETACHMENT CONTROL BOX WAS ALSO USED IN THE CASE. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156303 ↗
• MalfunctionJul 13, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENTERPRISE 2 STENT-ASSISTED COIL EMBOLIZATION OF A 4.9 MM X 4.6 MM (4.4 MM NECK) LEFT OPHTHALMIC INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE 2 MM X 3 CM GALAXY G3 MINI (GLM920030/S15138) THERMO-MECHANICAL COIL WAS ADVANCED TO THE MICROCATHETER TIP IN THE EXISTING COIL MASS, BUT THE PHYSICIAN FELT THE COIL WAS NO LONGER RESPONDING TO ADVANCEMENT OR WITHDRAWAL AND MAY HAVE STRETCHED. THE PROWLER LP/ES (606-S155X/17687035) MICROCATHETER AND COIL WERE PULLED BACK TOGETHER AS A UNIT FROM THE COIL MASS. UPON THEIR WITHDRAWAL, THE PROXIMAL 1 CM OF THE PREVIOUS 3 MM X 4 CM GALAXY G3 MINI (GLM930040/UNK LOT) COIL CAME OUT OF THE ANEURYSM. THE MICROCATHETER AND 2 MM X 3 CM GALAXY G3 MINI COIL WERE REMOVED FROM THE PATIENT. THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. ANGIOGRAPHY WAS PERFORMED AND THE PHYSICIAN DETERMINED THAT THE COIL EMBOLIZATION WAS COMPLETE. A 4 MM X 23 MM ENTERPRISE 2 STENT (ENF402300/UNK LOT) WAS IMPLANTED ACROSS THE NECK OF THE ANEURYSM. THE SALES REPRESENTATIVE GENTLY REMOVED THE COIL FROM THE MICROCATHETER AND NO VISIBLE DAMAGE WAS NOTED TO THE EMBOLIC COIL. REPORTEDLY, N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7686566 ↗

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).