NAMIC 80641962Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40193489067522), received between Sep 28, 2026 and Sep 28, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 12, 2025Open, Classified

   The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

   Z-1428-2025 · Root cause: Process change control · FDA record ↗

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 28, 2026Crack

  It was reported that Pressure tubing that connects manifold to white port of Swan Ganz catheter had a small hole in the hub. pack has 5 each, all are compromised.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915408 ↗