ORBIT GALAXY 640CF0201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704030188), received between Aug 13, 2019 and Aug 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Stretched” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 13, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION FOR THE INTERNAL MAMMARY ARTERY, A 2.5 X 5 OG COMPLEX FILL COIL (640 CF2505, 17736321) BECAME KINKED AT THE DELIVERY WIRE AND IT GOT DAMAGED AT THE SHEATH. THEREFORE, THE COMPLAINT PRODUCT WAS REPLACED WITH ANOTHER NEW PRODUCT. AFTER THAT, THE PROCEDURE COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY REPORTED. INITIALLY, THE DEVICE WAS PREPPED WITHOUT ANY PROBLEM. AT FIRST, THE OG COMPLEX FILL COIL WAS USED WITHOUT ANY PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL. BASED ON THE ANALYSIS OF THE DEVICE, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889978 ↗