NAMIC 64046007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489059458), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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, 2026Loss of or Failure to Bond

  It was reported that "We seem to be having an issue with many of the protection stations breaking or coming in broken from a specific lot #. INR has had 4 manifold break while setting up the table and 1 came in broken in the package."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947174 ↗