NAMIC 65030131Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489060065), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. Mar 24, 2026Open, Classified

   Medline has identified the presence of particulate within the fluid path of the Manifolds.

   Z-2145-2026 · Root cause: Under Investigation by firm · 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 30, 2026Material Deformation

  It was reported that several of their manifold kits (which arrive in all different packs) were arriving with the check valve on the waste bag made backwards and the tubing was coming packaged so tighly wound together that it was causing kinks and making it very difficult to unwind, especially in emergency situations. The tubing is knotted together and the quality is noticably worse.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946188 ↗