NAMIC 60122271Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489046144), received between Jan 15, 2025 and Mar 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE "DEVICE WAS BEING USED TO INJECT A CONTRAST/SALINE MIX TO VIEW CORONARY ARTERIES DURING PROCEDURE AND WHEN PHYSICIAN LET GO OF SYRINGE AFTER INJECTION THE SYRINGE SPUN BY ITSELF IN COUNTERCLOCKWISE DIRECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595193 ↗
• MalfunctionMar 7, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THERE WERE MULTIPLE INCIDENTS OF THE SYRINGE FALLING OFF THE MANIFOLD DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549201 ↗
• MalfunctionMar 7, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE "DEVICE WAS BEING USED TO INJECT A CONTRAST/SALINE MIX TO VIEW CORONARY ARTERIES DURING PROCEDURE AND WHEN PHYSICIAN LET GO OF SYRINGE AFTER INJECTION THE SYRINGE SPUN BY ITSELF IN COUNTERCLOCKWISE DIRECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548887 ↗
• MalfunctionJan 15, 2025Connection Problem; Connection Problem

  ACCORDING TO THE FACILITY, THE SYRINGE THAT ATTACHES TO THE MANIFOLD WILL LOOSEN/DETACH DURING CARE EVEN IF THE STAFF TIGHTENS BEFORE USE.

  Patient problems: Insufficient Information

  MAUDE report 21161999 ↗