ORBIT GALAXY ENPOWER 641CF0721Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10878528009617), received between Jun 2, 2017 and Nov 5, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2019Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, AN UNSPECIFIED MICROCATHETER (MC) WAS PLACED IN THE ANEURYSM. WHILE ADVANCING A 7MM X 21CM ORBIT GALAXY G2 COIL (641CF0721, S13606) AS THE SECOND COIL IN THE MICROCATHETER, PROXIMALLY IT DIDN'T SHOW ANY RESISTANCE AFTER THE DOCTOR PULLED THE COIL SHEATH BACKWARDS, HOWEVER, WHEN ADVANCING THE COIL, RESISTANCE OCCURRED AT THE MICROCATHETER HUB. WHEN THE COIL WAS ATTEMPTED TO RESHEATHED, IT BECAME STRETCHED. IT WAS NOT POSITIONED TO BE USED FOR THE COILING PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280125 ↗
• MalfunctionDec 14, 2018Stretched; Material Twisted/Bent; Positioning Problem; Stretched; Material Twisted/Bent; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 7MM X 21CM G2 STRETCH RESISTANT COMPLEX FILL COIL (641CF0721/LOT# NOT AVAILABLE) ENCOUNTERED RESISTANCE FRICTION AND WAS BENT DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8165215 ↗
• MalfunctionJun 2, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A BASILAR ARTERY ANEURYSM, A G2TDL COMPLEX FILL COIL (641CF0721/ S12761) FAILED TO DETACH WITH USING CABLES WITH DIFFERENT LOTS AND A DETACHMENT CONTROL BOX (DCB00000500/C20654) . THE COIL WAS REMOVED FROM THE MICROCATHETER WITHOUT DIFFICULTY AND THE PROCEDURE WAS CONTINUED WITHOUT CONSEQUENCE FOR THE PATIENT; HOWEVER, THE PROCEDURE WAS DELAYED AND RISKIER DUE TO THE EVENT AND THE PROCEDURE WAS DELAYED 20 MINUTES. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED AND THE SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS FIT PROPERLY WITHOUT NEED FOR EXCESSIVE FORCE. IT WAS REPORTED THAT PRODUCT WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6607575 ↗