GALAXY G3 GLX120201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704077633), received between Sep 21, 2017 and Feb 25, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) STUDY, A (B)(6)-YEAR OLD FEMALE (SUBJECT (B)(4)) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR CEREBRAL ARTERY (ACA) BIFURCATION ANEURYSM ON (B)(6) 2019 AND EXPERIENCED INTRAOPERATIVE ANEURYSM RE-RUPTURE AFTER PLACING A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505/L13753) COIL. THE RUPTURE RESOLVED ON THE SAME DAY WITH TEMPORARY BALLOON OCCLUSION AND FURTHER COILING. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS MODERATE IN SEVERITY AND WAS POSSIBLY RELATED TO THE STUDY DEVICE. THERE WAS ALSO A THROMBOEMBOLIC EVENT AT THE NECK OF THE ANEURYSM (AT THE TRANSITION OF THE RIGHT ANTERIOR COMMUNICATING ARTERY AND THE A2 SEGMENT OF THE LEFT ACA). THE PATIENT WAS ASYMPTOMATIC (ONLY OBSERVED ANGIOGRAPHICALLY) AND INTEGRILIN IIB IIIA WAS ADMINISTERED FOR 24-HOURS. ON (B)(6) 2019, ANGIOGRAPHY REVEALED A RUPTURED ANEURYSM AT THE LEFT ACA BIFURCATION. THE ANEURYSM HEIGHT WAS 2.0MM AND DOME WAS 3.2MM. THE MAXIMUM ANEURYSM DIAMETER WAS 4.4MM, NECK SIZE WAS 3.1MM AND DOME-TO-NECK RATIO WAS 1.0MM. THE PARENT VESSEL DIAMETER WAS 2.5MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406/L13761), ONE 2.5MM X 5

  Patient problems: Thromboembolism

  MAUDE report 9751448 ↗
• MalfunctionSep 21, 2017Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT AN XTRASOFT 2X2 COIL (GLX120201/S12157) WAS USED DURING A PROCEDURE WHERE THE PHYSICIAN HEARD A DETACHMENT SIGNAL BUT THE XTRASOFT 2X2 COIL WAS NOT DETACHED, THEN AT THE SECOND BEEP IT WAS PARTIALLY DETACHED SO IT STAYED PARTIALLY IN THE ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6884006 ↗