GALAXY G3 GLY121230Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704077398), received between Apr 3, 2018 and Apr 3, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult To Position” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2018Kinked; Knotted; Difficult To Position; Material Twisted/Bent; Kinked; Knotted; Difficult To Position; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE TREATMENT OF AN UNRUPTURED WIDE NECK BASILAR TIP ANEURYSM WITH THE FOLLOWING DIMENSIONS: NECK: 8 MM; HEIGHT: 11 MM; WIDTH: 10 MM; DIAMETER: 14 MM ON A (B)(6) FEMALE PATIENT WHOSE VESSEL TORTUOSITY IS LOW, USING THE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE, THE 6FR SHEATH RIGHT FEMORAL ARTERY WAS USED AND THE GUIDE CATHETER (PENUMBRA BENCHMARK .071¿ 95 CM) WAS INSERTED INTO THE LEFT VERTEBRAL ARTERY. THE PROWLER SELECT PLUS MICROCATHETER AND THE GUIDEWIRE (STRYKER SYNCHRO2 .014¿) WERE INSERTED INTO THE NECK OF THE ANEURYSM IN THE BASILAR ARTERY. THE PULSERIDER DEVICE WAS ADVANCED INTRA-ANEURYSMALLY WITH GOOD POSITION. A HEADWAY DUO MICROCATHETER WAS THEN ADVANCED WITH THE SYNCHRO2 .014¿ THROUGH THE PULSERIDER DEVICE INTO THE ANEURYSM. THE GALAXY G3 12 MM X 30 CM COIL WAS THEN ADVANCED THROUGH THE HEADWAY DUO MICROCATHETER INTO THE ANEURYSM WITH MULTIPLE POSITIONING AND RE-POSITIONING UNTIL THE PHYSICIAN ACHIEVED THE FINAL POSITION. ANGIOGRAPHIC CONTRAST INJECTIONS WERE PERFORMED AT THIS POINT TO CHECK THE POSITION OF THE COIL; THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITION AND DECIDED TO PULL THE COIL BACK THROUGH THE MIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393390 ↗