NAMIC 60060201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489043594), received between Aug 7, 2025 and Aug 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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. 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.

• MalfunctionAug 12, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THERE HAVE BEEN MULTIPLE INCIDENTS WHERE THE SYRINGE IS UN-SWIVELING FROM THE MANIFOLD PRIOR TO USE ON A PATIENT FOR A HEART CATH PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790567 ↗
• MalfunctionAug 7, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THERE HAVE BEEN "MULTIPLE" INCIDENTS WHERE THE SYRINGE IS "UN-SWIVELING FROM THE MANIFOLD" PRIOR TO USE ON A PATIENT FOR A "HEART CATH" PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22744325 ↗