NA 6057-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000058968), received between Oct 28, 2025 and Oct 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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.

• MalfunctionOct 28, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO USE THE STYLETS STERILE BARRIER WAS BREACHED. IT WAS NOTED THAT A CONTAINER WITH A BAG OF ICE WAS INAD VERTENTLY LEFT NEAR STYLETS AND ICE SEEPED INTO THE STYLET PACKAGING. IT WAS NOTED THAT WATER INSULATION WAS FOUND IN STYLET PACKAGING. THE STYLETS WERE ATTEMPTED/NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400785 ↗