MEDLINE ECVC7680Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653160348160), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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.

• MalfunctionSep 30, 2026Material Twisted/Bent; Component Misassembled

  This VMSR report summarizes 1 malfunction event that occurred between January 1 and March 31, 2023. The account reported that guidewires contained within EGW2008 kits experienced kinking during use. Multiple physicians reported experiencing guidewire kinking while using the kits. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945790 ↗