NAMIC 60183137Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489049930), received between Sep 6, 2024 and Sep 28, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 28, 2026Loss of or Failure to Bond

  It was reported that "Transducer cracked during setup of procedure.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917408 ↗
• InjurySep 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AIR IN SYRINGE.

  Patient problems: Air Embolism

  MAUDE report 20157191 ↗