GALAXY G3 GLY122535Recalls & reported problems
Cerenovus, Inc. · GALAXY G3 Microcoil 12 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: GALAXY G3 12 Stretch Resistant Coil 2.5mm (coil diameter) x 3.5cm (coil length) 190cm (working length) · Class 2 · Implant
All models of GALAXY G3 (58)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704077404), received between Jul 3, 2025 and Jul 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Separation Failure; Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) WAS IN PLACE AND THE 2.5MM X 3.5CM GALAXY G3 (GLY122535 / 3342403S) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT IT WAS UNABLE TO BE DETACHED. THE PHYSICIAN INSPECTED THE INDICATOR LIGHT OF THE DETACHMENT BOX AND THE CONTROL CABLE AND NOTED THAT ALL WERE IN GOOD CONDITION. THE PHYSICIAN PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 02-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET WAS AN UNRUPTURED 5MM X 7MM OVAL-SHAPED ANEURYSM ON THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE FAULT LIGHT WAS NOT SEEN DURING THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396563 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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