NAMIC 601604710Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489071795), received between Mar 5, 2026 and Mar 6, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Loose or Intermittent Connection

  ACCORDING TO THE FACILITY, ON 2/9/2026, THE CONTROL SYRINGE WAS BACKING OFF THE MANIFOLD DURING PROCEDURES. CUSTOMER REPORTS THIS IS A SAFETY CONCERN FOR AIR LEAKS WITH THESE COMING LOSE OR OFF DURING TRANSEPTAL PROCEDURES IN THE LEFT ATRIUM. THE MANIFOLD WAS REPLACED AND THE SAME ISSUE OCCURRED. THE FACILITY REPORTS NO INJURIES OCCURRED AND NO MEDICAL TREATMENT WAS NEEDED. NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533463 ↗
• MalfunctionMar 6, 2026No Apparent Adverse Event

  ACCORDING TO THE FACILITY ON 2/9/2026, THE CONTROL SYRINGE WAS REPORTED TO COME OFF THE BACK OF THE MANIFOLD DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533136 ↗
• MalfunctionMar 5, 2026Connection Problem

  IT WAS REPORTED THAT "CONTROL SYRINGE BACKING OFF OF THE MANIFOLD DURING PROCEDURES." DUE TO THIS, "THREW AWAY THE MANIFOLD, REPLACED IT WITH ANOTHER ONE OFF THE SHELF ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526802 ↗
• MalfunctionMar 5, 2026Loose or Intermittent Connection

  ACCORDING TO THE FACILITY ON 2/9/2026, THE CONTROL SYRINGE WAS REPORTED TO BACK OFF OF THE MANIFOLD DURING USE. THE FACILITY REPORTED THIS AS A SAFETY CONCERN FOR POTENTIAL AIR LEAK DURING TRANSSEPTAL PROCEDURES ON THE LEFT ATRIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525108 ↗