NAMIC 650108610Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489074857), received between Mar 7, 2024 and Sep 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 27, 2026Open, Classified

   Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

   Z-1718-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fluid/Blood Leak

  It was reported that "THERE IS A LEAK IN THE Y-CONNECTOR ON THE PTCA KIT. THE FLUSH BAG IS LEAKING IN TO THE WASTE BAG . THEY BELIEVE THE VALVE IS INCOMPETENT ALLOWING THE FLUSH BAG TO DRAIN COMPLETELY AT START OF CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898130 ↗
• MalfunctionMar 7, 2024Mechanical Problem; Mechanical Problem

  STAFF NOTICED THERE IS A LEAK IN THE Y-CONNECTOR ON THE PTCA KIT. THE FLUSH BAG IS LEAKING IN TO THE WASTE BAG. THEY BELIEVE THE VALVE IS INCOMPETENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859478 ↗