NAMIC 80038301 (UDI 20193489066507)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20193489066507), received between Mar 2, 2026 and Sep 30, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (9 reports).

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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Loose or Intermittent Connection

  It was reported that "During the angioplasty part of the procedure (using Second Pk) the syringe and manifold started becoming loose."

  Patient problems: Hemodynamic instability; Myocardial Infarction; Ventricular Fibrillation

  MAUDE report 50945563 ↗
• MalfunctionSep 29, 2026Disconnection; Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937465 ↗
• MalfunctionSep 29, 2026Loose or Intermittent Connection

  Patient problems: Myocardial Infarction

  MAUDE report 50936717 ↗
• MalfunctionSep 29, 2026Disconnection; Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934122 ↗
• MalfunctionApr 8, 2026Loose or Intermittent Connection; Connection Problem

  ACCORDING TO THE FACILITY, THE SYRINGE WAS SPINNING OFF THE MANIFOLD WHEN ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821242 ↗
• MalfunctionMar 25, 2026Connection Problem

  IT WAS REPORTED THAT SYRINGE WOULD NOT STAY CONNECTED TO MANIFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690578 ↗
• MalfunctionMar 17, 2026Connection Problem

  IT WAS REPORTED THAT THE "HAND INJECTION SYRINGE DISCONNECTED BY ITSELF".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621043 ↗
• MalfunctionMar 17, 2026Connection Problem

  IT WAS REPORTED THAT THE "HAND INJECTION SYRINGE DISCONNECTED BY ITSELF".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616200 ↗
• MalfunctionMar 16, 2026Connection Problem

  IT WAS REPORTED THAT THE "HAND INJECTION SYRINGE DISCONNECTED BY ITSELF". NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612325 ↗
• MalfunctionMar 13, 2026Connection Problem

  IT WAS REPORTED THAT "THE SYRINGE WOULDN'T LOCK, IT KEPT ON UNSCREWING ITSELF EVEN BEFORE USING IT AND WHILE PRIMING WITH CONTRAST." PER THE CUSTOMER THE "SYRINGE [WAS] REPLACED AND STILL UNSCREWING AND SO MANIFOLD ALSO CHANGED."

  Patient problems: Insufficient Information

  MAUDE report 24590725 ↗
• MalfunctionMar 10, 2026Leak/Splash; Loose or Intermittent Connection

  ACCORDING TO THE FACILITY, AFTER FIRST SHOT OF RIGHT CORONARY ARTERY, THE SYRINGE CONNECTION BECAME LOOSE, AND CONTRAST RAN OUT FROM THE CONNECTION. SYRINGE WAS UNSTABLE TO STAY ON MANIFOLD, AND THE SYRINGE WAS CHANGED OUT.

  Patient problems: Insufficient Information

  MAUDE report 24562852 ↗
• MalfunctionMar 9, 2026Damaged Thread

  IT WAS REPORTED, "SYRINGE KEPT UNTHREADING FROM MANIFOLD DESPITE BEING TIGHTENED MULTIPLE TIMES, MANIFOLD REPLACED."

  Patient problems: Insufficient Information

  MAUDE report 24551692 ↗
• MalfunctionMar 2, 2026Incomplete or Inadequate Connection

  ACCORDING TO THE CUSTOMER CONTACT, "SYRINGE WOULD NOT CONNECT TO MANIFOLD DURING SETUP. NEW SYRINGE OPENED AND STILL WOULD NOT CONNECT TO THE MANIFOLD. NEW SINGLE MANIFOLD OPENED AND THE SYRINGE CONNECTED TO NEW MANIFOLD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491650 ↗
• MalfunctionMar 2, 2026Loose or Intermittent Connection

  ACCORDING TO THE CUSTOMER CONTACT, "HAND INJECTION 3 WAY TAP + SYRINGE WERE WELL CONNECTED AT BEGINNING OF CASE THEN SYRINGE STARTED TO BECOME LOOSE AND UNTWIST OFF THE MANIFOLD DURING PCI. MANIFOLD CHANGED BUT STILL ISSUE OCCURRED. ENTIRE KIT CHANGED HOWEVER SAME ISSUE OCCURRED WITH NEW SET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489271 ↗
• MalfunctionMar 2, 2026Loose or Intermittent Connection

  ACCORDING TO THE CUSTOMER CONTACT, "SYRINGE WOULD NOT CONNECT TO MANIFOLD DURING SETUP.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484676 ↗
• MalfunctionMar 2, 2026Loose or Intermittent Connection

  ACCORDING TO THE CUSTOMER CONTACT, "HAND INJECTION 3 WAY TAP + SYRINGE WERE WELL CONNECTED AT BEGINNING OF CASE THEN SYRINGE STARTED TO BECOME LOOSE AND UNTWIST OFF THE MANIFOLD DURING PCI. MANIFOLD CHANGED BUT STILL ISSUE OCCURRED. ENTIRE KIT CHANGED HOWEVER SAME ISSUE OCCURRED WITH NEW SET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482734 ↗