ORBIT GALAXY ENPOWER 641CF0308Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10878528009488), received between Sep 2, 2016 and Feb 24, 2017 — classified as 2 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 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.

• MalfunctionFeb 24, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A G2 COMPLEX FILL COIL STRETCHED AFTER THE FIRST OPTICAL INSPECTION WHILE PULLING IT BACK INTO THE INTRODUCER SHEATH. THE COIL WAS NOT USED ON THE PATIENT AND HAD BEEN STORED CORRECTLY. WHEN ADVANCING THE DPU WIRE THROUGH THE INTRODUCER SHEATH TO INSPECT THE COIL, IT MOVED SMOOTHLY THROUGH THE SHEATH WITH NO RESISTANCE. WHEN THE COIL WAS EXPOSED, THERE WERE NO KINKS, BURRS, STRETCHING STRIATIONS OR OTHER DAMAGED NOTICED. THERE WERE NO KNOWN FACTORS THAT MAY HAVE CONTRIBUTED TO THE COIL STRETCHING. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE PRODUCT WITH NO PATIENT INJURY OR SIGNIFICANT DELAY REPORTED. IT WAS REPORTED THAT THE PRODUCT WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6356116 ↗
• MalfunctionSep 2, 2016Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE A GALAXY2 COIL (641CF0308/P11823) COULD NOT BE ADVANCED INTO A PROWLER SELECT PLUS MICROCATHETER (LOT UNKNOWN) AND POKED THROUGH SLIT IN THE PROTECTIVE SHEATH. IT WAS REPORTED THAT MULTIPLE GALAXY 2 COILS WERE SUCCESSFULLY DEPLOYED, IT IS UNKNOWN IF THEY WERE DEPLOYED PRIOR TO OR AFTER THE EVENT. THERE WERE NO SERIOUS INJURIES TO THE PATIENT OR MEDICAL INTERVENTIONS REQUIRED DUE TO THE REPORTED EVENT. THE EVENT OCCURRED PRIOR TO THE PRODUCT BEING INTRODUCED INTO THE PATIENT. PATIENT DETAILS AND PROCEDURE INFORMATION ARE UNKNOWN. IT WAS REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5925535 ↗