NAMIC 613000163Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489074550), received between Jul 18, 2025 and Sep 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948821 ↗
• MalfunctionSep 28, 2026Break

  It was reported that "have had atleast three kits now that have had a part of the AO Line break off when we are getting the set ready to use. They all are coming from the same lot number."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914395 ↗
• MalfunctionJul 18, 2025Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT THE SYRINGE DOES NOT LOCK ONTO THE MANIFOLD SECURELY, ALLOWING AIR INTO THE MANIFOLD SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22549175 ↗