NAMIC 650204216Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489074901), received between Mar 24, 2026 and Mar 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT TECHNICIANS HAVE REPORTED THAT THE SYRINGE IS UNRAVELING FROM THE ATTACHED MANIFOLD PORT AND THAT THE SYRINGE IS VERY WOBBLY WHEN ATTACHED TO THE MANIFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24692006 ↗
• MalfunctionMar 25, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT "TECHNICIANS HAVE REPORTED THAT THE SYRINGE IS UNRAVELING FROM THE ATTACHED MANIFOLD PORT" AND THAT "THE SYRINGE IS VERY WOBBLY WHEN ATTACHED TO THE MANIFOLD." PER THE CUSTOMER "THIS HAS BEEN SEEN THREE TIMES IN THE LAST WEEK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687203 ↗
• MalfunctionMar 24, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT "TECHNICIANS HAVE REPORTED THAT THE SYRINGE IS UNRAVELING FROM THE ATTACHED MANIFOLD PORT" AND THAT "THE SYRINGE IS VERY WOBBLY WHEN ATTACHED TO THE MANIFOLD." PER THE CUSTOMER "THIS HAS BEEN SEEN THREE TIMES IN THE LAST WEEK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680700 ↗