GALAXY G3Recalls & reported problems across all models

Cerenovus, Inc. · 58 models in the FDA device registry

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

Adverse event reports: 1,386
Deaths reported: 11
Injuries reported: 389
Recalls: 1

We found 58 models of GALAXY G3 by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 1,386 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2016 and Sep 30, 2026 — classified as 11 deaths, 389 injuries, 986 malfunctions.

The most frequently reported specific device problem is “Stretched” (296 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Last 36 months. The most recent month may be incomplete.

GALAXY G3 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

May 16, 2019Terminated
Incorrect coil length on the label
Z-2280-2019 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported GALAXY G3 problems

Device problems

Stretched296
Adverse Event Without Identified Device or Use Problem248
Separation Failure241
Failure to Advance188
Deformation Due to Compressive Stress136
Material Twisted/Bent125
Difficult to Advance117
Positioning Problem74

Patient problems

No Clinical Signs, Symptoms or Conditions667
No Consequences Or Impact To Patient349
Aneurysm194
Thromboembolism45
No Code Available41
Ischemia Stroke32
Ruptured Aneurysm29
Stroke/CVA26

GALAXY G3 models

58 models, most reported first. Each model has its own page with its reports, recalls and device details.

GALAXY G3 GLM915020
DEVICE, NEUROVASCULAR EMBOLIZATION
1 recall44 reports
GALAXY G3 GLM920060
Device, Vascular, for Promoting Embolization
89 reports
GALAXY G3 GLM910030
Device, Vascular, for Promoting Embolization
79 reports
GALAXY G3 GLM910040
Device, Vascular, for Promoting Embolization
77 reports
GALAXY G3 GLM910020
DEVICE, NEUROVASCULAR EMBOLIZATION
67 reports
GALAXY G3 GLY120515
DEVICE, NEUROVASCULAR EMBOLIZATION
51 reports
GALAXY G3 GLX120306
DEVICE, NEUROVASCULAR EMBOLIZATION
51 reports
GALAXY G3 GLM915030
Device, Vascular, for Promoting Embolization
51 reports
GALAXY G3 GLM920030
DEVICE, NEUROVASCULAR EMBOLIZATION
48 reports
GALAXY G3 GLM920040
DEVICE, NEUROVASCULAR EMBOLIZATION
47 reports
GALAXY G3 GLM915040
DEVICE, NEUROVASCULAR EMBOLIZATION
40 reports
GALAXY G3 GLX120208
DEVICE, NEUROVASCULAR EMBOLIZATION
3 deaths38 reports
GALAXY G3 GLY120308
Device, Vascular, for Promoting Embolization
33 reports
GALAXY G3 GLX120202
Device, Vascular, for Promoting Embolization
3 deaths32 reports
GALAXY G3 GLX120410
Device, Vascular, for Promoting Embolization
32 reports
GALAXY G3 GLX120408
Device, Vascular, for Promoting Embolization
32 reports
GALAXY G3 GLM930060
Device, Vascular, for Promoting Embolization
1 death32 reports
GALAXY G3 GLY120412
DEVICE, NEUROVASCULAR EMBOLIZATION
31 reports
GALAXY G3 GLX122505
DEVICE, NEUROVASCULAR EMBOLIZATION
1 death28 reports
GALAXY G3 GLX120308
DEVICE, NEUROVASCULAR EMBOLIZATION
27 reports
GALAXY G3 GLM910010
Device, Vascular, for Promoting Embolization
26 reports
GALAXY G3 GLY120620
Device, Vascular, for Promoting Embolization
24 reports
GALAXY G3 GLX120304
Device, Vascular, for Promoting Embolization
24 reports
GALAXY G3 GLM925045
Device, Vascular, for Promoting Embolization
23 reports
GALAXY G3 GLY120721
DEVICE, NEUROVASCULAR EMBOLIZATION
21 reports
GALAXY G3 GLX120406
DEVICE, NEUROVASCULAR EMBOLIZATION
21 reports
GALAXY G3 GLY120615
DEVICE, NEUROVASCULAR EMBOLIZATION
20 reports
GALAXY G3 GLY120510
DEVICE, NEUROVASCULAR EMBOLIZATION
19 reports
GALAXY G3 GLY120824
Device, Vascular, for Promoting Embolization
19 reports
GALAXY G3 GLX122535
Device, Vascular, for Promoting Embolization
19 reports
GALAXY G3 GLX123575
Device, Vascular, for Promoting Embolization
19 reports
GALAXY G3 GLX120204
DEVICE, NEUROVASCULAR EMBOLIZATION
2 deaths19 reports
GALAXY G3 GLM930080
Device, Vascular, for Promoting Embolization
17 reports
GALAXY G3 GLM915025
DEVICE, NEUROVASCULAR EMBOLIZATION
16 reports
GALAXY G3 GLM910015
DEVICE, NEUROVASCULAR EMBOLIZATION
16 reports
GALAXY G3 GLY120410
DEVICE, NEUROVASCULAR EMBOLIZATION
14 reports
GALAXY G3 GLY120925
Device, Vascular, for Promoting Embolization
14 reports
GALAXY G3 GLM925035
DEVICE, NEUROVASCULAR EMBOLIZATION
14 reports
GALAXY G3 GLY123509
DEVICE, NEUROVASCULAR EMBOLIZATION
12 reports
GALAXY G3 GLM930040
DEVICE, NEUROVASCULAR EMBOLIZATION
12 reports
GALAXY G3 GLX120206
Device, Vascular, for Promoting Embolization
10 reports
GALAXY G3 GLY120306
Device, Vascular, for Promoting Embolization
8 reports
GALAXY G3 GLM910025
Device, Vascular, for Promoting Embolization
8 reports
GALAXY G3 GLX122525
DEVICE, NEUROVASCULAR EMBOLIZATION
7 reports
GALAXY G3 GLX123509
DEVICE, NEUROVASCULAR EMBOLIZATION
7 reports
GALAXY G3 GLM925055
Device, Vascular, for Promoting Embolization
7 reports
GALAXY G3 GLY122505
Device, Vascular, for Promoting Embolization
1 death6 reports
GALAXY G3 GLY123575
DEVICE, NEUROVASCULAR EMBOLIZATION
5 reports
GALAXY G3 GLY120407
Device, Vascular, for Promoting Embolization
5 reports
GALAXY G3 GLX123505
Device, Vascular, for Promoting Embolization
5 reports
GALAXY G3 GLY121030
Device, Vascular, for Promoting Embolization
4 reports
GALAXY G3 GLY120610
DEVICE, NEUROVASCULAR EMBOLIZATION
4 reports
GALAXY G3 GLY120202
DEVICE, NEUROVASCULAR EMBOLIZATION
3 reports
GALAXY G3 GLY120715
DEVICE, NEUROVASCULAR EMBOLIZATION
3 reports
GALAXY G3 GLY120815
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
GALAXY G3 GLX120201
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
GALAXY G3 GLY121230
Device, Vascular, for Promoting Embolization
1 report
GALAXY G3 GLY122535
DEVICE, NEUROVASCULAR EMBOLIZATION
1 report

Recent GALAXY G3 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Separation Failure; Component or Accessory Incompatibility
A healthcare professional reported that this was a coil embolization using a GALAXY G3 5MM X 15CM Coil (product code: GLY120515, lot number: 2512562S). During coil detachment, connection to the main unit could not be made, so the device could not be detached and was removed. The reported product issue was failure to detach with connection incompatibility at the detachment interface. No patient consequences or clinical signs or symptoms were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949613 ↗
MalfunctionAug 7, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50178268 ↗
MalfunctionJul 1, 2026Failure to Advance
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE GALAXY G3 MINI 3MM X 8CM COIL (GLM930080/1742522S) WAS IMPEDED IN THE PROXIMAL OF THE MICROCATHETER (NON-J&J) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED A SECOND GALAXY G3 MINI 3MM X 8CM COIL (GLM930080/1742522S), AND THE SECOND COIL HAD THE SAME ISSUE. THE PHYSICIAN ONLY RETRACTED THE SECOND COIL ALONE AND SWITCHED A THIRD COIL (NON-J&J) TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO PATIENT INJURY WAS REPORTED IN ASSOCIATION WITH THE EVENTS. THE PROCEDURE INVOLVED THE USE OF A MICROCATHETER FROM ANOTHER MANUFACTURER. OTHER DEVICES WERE SUCCESSFULLY USED BEFORE AND/OR AFTER THE REPORTED RESISTANCE. THE TARGET VESSEL WAS THE INTERNAL CAROTID ARTERY. RELEVANT ANATOMICAL DETAILS WERE NOT AVAILABLE. DURING THE PROCEDURE, RESISTANCE WAS NOTED AT THE MID-SECTION OF THE MICROCATHETER. CONTINUOUS FLUSHING WAS MAINTAINED, AND THE INTRODUCER TIP WAS PROPERLY CONNECTED TO THE MICROCATHETER HUB AND SECURED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS OF THE D
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680042 ↗
MalfunctionJul 1, 2026Failure to Advance
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE GALAXY G3 MINI 3MM X 8CM COIL (GLM930080/1742522S) WAS IMPEDED IN THE PROXIMAL OF THE MICROCATHETER (NON-J&J) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED A SECOND GALAXY G3 MINI 3MM X 8CM COIL (GLM930080/1742522S), AND THE SECOND COIL HAD THE SAME ISSUE. THE PHYSICIAN ONLY RETRACTED THE SECOND COIL ALONE AND SWITCHED A THIRD COIL (NON-J&J) TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO PATIENT INJURY WAS REPORTED IN ASSOCIATION WITH THE EVENTS. THE PROCEDURE INVOLVED THE USE OF A MICROCATHETER FROM ANOTHER MANUFACTURER. OTHER DEVICES WERE SUCCESSFULLY USED BEFORE AND/OR AFTER THE REPORTED RESISTANCE. THE TARGET VESSEL WAS THE INTERNAL CAROTID ARTERY. RELEVANT ANATOMICAL DETAILS WERE NOT AVAILABLE. DURING THE PROCEDURE, RESISTANCE WAS NOTED AT THE MID-SECTION OF THE MICROCATHETER. CONTINUOUS FLUSHING WAS MAINTAINED, AND THE INTRODUCER TIP WAS PROPERLY CONNECTED TO THE MICROCATHETER HUB AND SECURED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS OF THE D
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680014 ↗
MalfunctionJun 8, 2026Stretched
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, WHEN PACKING A GALAXY G3 MINI 2MM X 6CM COIL (PRODUCT CODE: GLM920060, LOT NUMBER: 1832524S) WITHIN THE ANEURYSM, THE DOCTOR OBSERVED AN ABNORMAL COIL CONFIGURATION UNDER IMAGING. THE DOCTOR RETRACTED THE COIL ALONE; THE COIL WAS FOUND TO BE UNRAVELED/STRETCHED. THE DOCTOR SWITCHED TO ANOTHER COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2026 INDICATED THAT PRIOR TO THIS COIL, OTHER COILS HAD BEEN ABLE TO BE ADVANCED THROUGH THE SAME MICROCATHETER. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THE COIL DID NOT PREMATURELY DETACH. THERE WAS NO RESISTANCE/FRICTION ENCOUNTERED WHILE ADVANCING THE COIL. THERE WAS NO RELEVANT ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS OR ANEURYSM CHARACTERISTICS. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428982 ↗
MalfunctionMay 29, 2026Failure to Advance
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE GALAXY G3 MINI 2MM X 6CM (GLM920060/1832524S) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO A NON-J&J MICROCATHETER. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURIES NOR CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE. AN ECHLON 10 MICROCATHETER (NON-J&J) WAS USED. NON-J&J COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER. THE TARGET VESSEL WAS THE INTERNAL CAROTID C6. NO RELEVANT ANATOMICAL INFORMATION WAS INCLUDED. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS CONFIRMED TO BE STRETCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331780 ↗
MalfunctionMay 13, 2026Device Difficult to Setup or Prepare; Failure 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 25158974 ↗
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 ↗
MalfunctionMay 5, 2026Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (DIFFERENT MANUFACTURER) WAS IN PLACE AND THE 3MM X 8CM GALAXY G3 (GLY120308 / 3092403S) 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 DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING AN ANEURYSM ON THE C6 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). TH COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED, IT WAS STILL ON THE DELIVERY WIRE. 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 WAS ALSO ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEP WAS HEARD. ALL CONNECTIONS FIT WITHOUT APPLICATION OF EXCESSIV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25084185 ↗
MalfunctionApr 28, 2026Failure to Advance; Positioning Problem
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A LESION ON THE DESCRING COLON TO TREAT A DIVERTICULAR HEMORRHAGE. DEVICES WERE USED ACCORDING TO THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). COIL EMBOLIZATION WAS INITIATED USING A 4FR ANGIOGRAPHIC CATHETER AND AN EXCELSIOR® 1018® MICROCATHETER (STRYKER). THE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 3382503S) WAS USED AS A FINISHING COIL, AFTER IMPLANTATION OF COILS FROM ANOTHER MANUFACTURER. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO DEPLOY THE GALAXY G3 MINI COIL, HOWEVER THE MICROCATHETER POSITION WAS UNSTABLE. THEREFORE, THE COIL WAS RE-SHEATHED AND THE MICROCATHETER POSITION WAS ADJUSTED USING A MICRO GUIDEWIRE. SUBSEQUENTLY, ANOTHER ATTEMPT WAS MADE TO USE THE SAME GALAXY G3 MINI COIL, BUT THE COIL CAUGHT AT THE SHEATH AND DID NOT EXIT FROM THE TIP. THE GALAXY G3 MINI WAS WITHDRAWN AND REPLACED WITH ANOTHER NEW COIL, AND THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO VISIBLE DAMAGE OBSERVED ON THE COIL SHEATH. DURING COIL RE-SHEATHING, THE COIL WAS NOT PULLED BACK BEYOND THE SHEATH PART. IN THE PHYSICIAN¿S OPINION, THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25023689 ↗
MalfunctionApr 17, 2026Material Separation; Failure to Advance
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 24918614 ↗
MalfunctionApr 17, 2026Material Separation; Failure to Advance
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 24918613 ↗
MalfunctionApr 17, 2026Material Separation; Failure to Advance
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 24918612 ↗
MalfunctionApr 16, 2026Failure to Advance
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 1832524S) WAS IMPEDED IN THE HUB OF THE ASSOCIATED MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH ANOTHER 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060) FROM LOT: 1612510S. THE SECOND COIL ENCOUNTERED THE SAME ISSUE. THE PHYSICIAN RETRACTED THIS SECOND COIL AND REPLACED IT AGAIN WITH A THIRD COIL AND COMPLETED THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 11-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE INTERNAL CAROTID ARTERY (ICA). THE INFORMATION ALSO INDICATED THAT THERE WAS PARTIAL VESSEL CALCIFICATION. COILS FROM OTHER MANUFACTURERS WERE SUCCESSFULLY USED WITH THE MICROCATHETER AFTER THE REPORTED RESISTANCE WAS ENCOUNTERED. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. DURING THE DEVICE ADVANCEMENT, THE RESPECTIVE INTRODUCERS WERE FIRMLY INSTALLED ONTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV). NO DAMAGE WAS NOTED ON THE DEVICES AT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905877 ↗
MalfunctionApr 16, 2026Failure to Advance
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1.50MM X 2.00CM GALAXY G3 MINI (GLM915020 / 0482510S) WAS IMPEDED IN THE PROXIMAL SECTION OF THE ASSOCIATED MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 06-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE PROCEDURE INDICATED THAT THE PROCEDURE WAS TARGETING THE LEFT MAIN CORONARY ARTERY (LMCA). CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE TIP OF THE COIL INTRODUCER WAS FIRMLY INSTALLED ONTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE DEVICE ADVANCEMENT. THE INFORMATION INDICATED THERE WAS NO DELAY IN THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 15-APR-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA MDR REPORTABLE AS A "MALFUNCTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905076 ↗

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Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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