NAMIC 60201611Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489051728), received between May 2, 2025 and May 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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.

• MalfunctionMay 2, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 "THE MANIFOLD SYRINGE USED IN THE AMULET PROCEDURE WOULD NOT STAY ATTACHED TO THE MANIFOLD ITSELF", AND "THE SYRINGE KEPT BACKING OFF AND INTRODUCING AIR TO THE SYSTEM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950732 ↗