ENVI 35-506Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965355060), received between May 26, 2022 and May 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2022Fracture; Fracture

  A RISK MANAGER REPORTED AN ISSUE WITH A NVI MINI STICK 6F X 20CM .018 NI/TU 21G CHIBA ECHO TIP, VIA USER FACILITY MEDWATCH. IT WAS REPORTED THAT THE END USER WAS ATTEMPTING TO PUSH THE WIRE THROUGH THE ACCESS NEEDLE, AND WHEN DOING SO, A PART OF THE "COPE WIRE" BROKE OFF INTO TWO PIECE'S INSIDE OF THE PATIENT'S HEPATIC VEIN. IT IS UNKNOWN IF THE WIRE HAD BEEN PULLED BACK AGAINST THE ACCESS NEEDLE WHEN ATTEMPTING TO PUSH IT THROUGH.THE TWO WIRE FRAGMENTS WERE RETAINED INSIDE THE PATIENT AS THE PROVIDER WAS UNABLE TO REMOVE THEM. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS REPORTED THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH HOSPICE CARE, NOT RELATED TO THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14517851 ↗