NAMIC 80055009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20193489066668), received between Nov 3, 2020 and Apr 3, 2026 — classified as 3 malfunctions.

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

• MalfunctionApr 3, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT "THE SYRINGE TURNS ITSELF LOOSE WHILE INJECTING THE CONTRAST MEDIUM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782430 ↗
• MalfunctionNov 3, 2020Gas/Air Leak

  IT WAS REPORTED, THERE WAS A LARGE COLUMN OF AIR. THE REPORTER STATES, "IT IS NOT KNOWN WHERE THE SOURCE OF THE LEAK IS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10778166 ↗
• MalfunctionNov 3, 2020Gas/Air Leak

  IT WAS REPORTED, THERE WAS A LARGE COLUMN OF AIR. A SECOND VALVE WAS IMPLANTED TO FIX THE LEAK AND STABILIZE THE FIRST VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10777453 ↗