NAMIC 80085007 (UDI 20193489066835)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 20193489066835), received between Oct 30, 2025 and Mar 31, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (23 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-1712-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Loose or Intermittent Connection; Connection Problem

  ACCORDING TO THE FACILITY, THEY STARTED LOSING CONNECTION OF SYRINGE AND MANIFOLD AFTER INJECTING 50 ML OF CONTRAST DURING CORONARY ANGIOGRAM, THEN SYRINGE STARTED SPINNING OUT ITSELF. UNABLE TO KEEP IT ATTACHED.

  Patient problems: Insufficient Information

  MAUDE report 24746791 ↗
• MalfunctionMar 26, 2026Connection Problem

  ACCORDING TO THE FACILITY, "THE RING GRIP SYRINGE KEEPS "UNTWISTING" FROM THE MANIFOLD. WE THREW OUT THE RING GRIP SYRINGE FOR A NEW ONE WITHOUT ANY CHANGE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706796 ↗
• MalfunctionMar 25, 2026Loose or Intermittent Connection

  ACCORDING TO THE REPORTER, THE SYRINGE USED FOR HAND INJECTION WAS NOT SECURE ON THE THREE WAY TAP DESPITE ATTEMPTS TO TIGHTEN IT. THE REPORTER STATED THAT THE HAND INJECTION KIT WAS REPLACED DURING SETUP AT THE BEGINNING OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695315 ↗
• MalfunctionMar 25, 2026Connection Problem

  ACCORDING TO THE FACILITY, "THE RING GRIP SYRINGE KEEPS "UNTWISTING" FROM THE MANIFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690455 ↗
• MalfunctionMar 25, 2026Loose or Intermittent Connection; Connection Problem

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

  Patient problems: Insufficient Information

  MAUDE report 24689236 ↗
• MalfunctionMar 25, 2026Loose or Intermittent Connection

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688716 ↗
• MalfunctionMar 6, 2026Connection Problem

  IT WAS REPORTED THAT THE "HAND INJECTION KIT WAS PRIMED AND CHECKED PRIOR TO START OF CASE, BUT WHEN IT WAS ATTACHED TO CATHETER, THE SYRINGE STARTED TO DISCONNECT." THE CUSTOMER DID NOT REPORT ANY PATIENT HARM AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532035 ↗
• MalfunctionMar 5, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT "THE SYRINGE UNSCREWED OFF THE MANIFOLD AND BECAME LOOSE SEVERAL TIMES ALLOWING CONTRAST BUBBLES TO FORM IN THE CONNECTION POINT." PER THE CUSTOMER CONTACT, AFTER A NEW MANIFOLD WAS PREPARED THE SYRINGE ONCE AGAIN CAME OFF THE MANIFOLD AND THE PROCEDURE CEASED SHORTLY AFTER.

  Patient problems: Insufficient Information

  MAUDE report 24526167 ↗
• MalfunctionMar 5, 2026Loose or Intermittent Connection

  ACCORDING TO THE CUSTOMER, THE SYRINGE UNSCREWED OFF THE MANIFOLD AND BECAME LOOSE SEVERAL TIMES ALLOWING CONTRAST BUBBLES TO FORM IN THE CONNECTION POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524251 ↗
• MalfunctionMar 5, 2026Loose or Intermittent Connection

  ACCORDING TO THE CUSTOMER CONTACT, "THE MANIFOLD CONNECTION WITH THE SYRINGE WAS NOT WORKING. SYRINGE DID NOT CONNECT PROPERLY TO MANIFOLD. DELAY IN STARTING PROCEDURE WITH NEW MANIFOLD OPENED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519458 ↗
• MalfunctionMar 5, 2026Connection Problem

  IT WAS REPORTED THAT THE "SYRINGE KEPT FALLING OFF THE MANIFOLD." PER THE CUSTOMER, THE "MANIFOLD WAS REPLACED AND IT WAS STILL FALLING OFF AND SO THE SYRINGE WAS REPLACED AND IT KEPT IN PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519079 ↗
• MalfunctionMar 5, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE "SYRINGE KEPT FALLING OFF THE MANIFOLD." PER THE CUSTOMER, THE "MANIFOLD WAS REPLACED AND IT WAS STILL FALLING OFF AND SO THE SYRINGE WAS REPLACED AND IT KEPT IN PLACE."

  Patient problems: Insufficient Information

  MAUDE report 24518939 ↗
• MalfunctionMar 4, 2026Connection Problem

  ACCORDING TO THE FACILITY, THE SYRINGE DID NOT CONNECT TO THE MANIFOLD PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512681 ↗
• MalfunctionMar 4, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE "SYRINGE WAS UNSCREWING FROM MANIFOLD." THE CUSTOMER REPORTED A NEW REPLACEMENT SYRINGE WAS OPENED AND "ALSO UNSCREWED." PER THE CUSTOMER, AN ADDITIONAL REPLACEMENT SYRINGE WAS OPENED AND "WORKED."

  Patient problems: Insufficient Information

  MAUDE report 24512367 ↗
• MalfunctionMar 4, 2026Loose or Intermittent Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE "SYRINGE WAS UNSCREWING FROM MANIFOLD." THE CUSTOMER REPORTED A NEW REPLACEMENT SYRINGE WAS OPENED AND "ALSO UNSCREWED." PER THE CUSTOMER, AN ADDITIONAL REPLACEMENT SYRINGE WAS OPENED AND "WORKED."

  Patient problems: Insufficient Information

  MAUDE report 24508147 ↗
• MalfunctionMar 3, 2026Connection Problem

  LOOSE SYRINGE TO MANIFOLD CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499703 ↗
• MalfunctionMar 3, 2026Connection Problem

  SYRINGE WOULD NOT STAY ATTACHED TO THE MANIFOLD. AS SOON AS THE SYRINGE WAS FILLED WITH CONTRAST IT WOULD TWIST OFF WHICH WOULD ALLOW AIR INTO THE SYSTEM. HAD TO CHANGE TO A NEW KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498361 ↗
• 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 24491122 ↗
• MalfunctionFeb 26, 2026Loose or Intermittent Connection

  ACCORDING TO THE CUSTOMER, A SYRINGE WAS REPORTED TO NOT CONNECT TO THE MANIFOLD DURING SETUP. A NEW SYRINGE WAS OPENED AND SUCCESSFULLY ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455007 ↗
• MalfunctionFeb 25, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT "THE SYRINGE UNSCREWED UNDER PRESSURE DURING THE PROCEDURE, WHICH WAS A CODE STEMI PATIENT."

  Patient problems: Insufficient Information

  MAUDE report 24449996 ↗
• MalfunctionFeb 25, 2026Connection Problem

  ACCORDING TO THE FACILITY, SYRINGE FELL OFF MANIFOLD DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447171 ↗
• MalfunctionFeb 24, 2026Loose or Intermittent Connection

  ACCORDING TO THE FACILITY, THE SYRINGE BECAME DISCONNECTED FROM THE MANIFOLD AT THE BEGINNING OF THE PROCEDURE, REQUIRING SETUP OF A NEW HAND INJECTION PACK AND PROLONGING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24438230 ↗
• MalfunctionFeb 24, 2026Connection Problem

  ACCORDING TO THE FACILITY, THE SYRINGE BECAME DISCONNECTED FROM THE MANIFOLD AT THE BEGINNING OF THE PROCEDURE, REQUIRING SETUP OF A NEW HAND INJECTION PACK AND PROLONGING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435708 ↗
• MalfunctionFeb 24, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING "SET UP FOR PREPARATION FOR STEMI (EMERGENCY) PATIENT, SYRINGE AND MANIFOLD WOULD NOT CONNECT PROPERLY AND SYRINGE WAS SCREWING BACK ON ITSELF DELAYING SET UP." A "NEW HAND INJECTION PACK OPENED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435032 ↗
• MalfunctionFeb 24, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING "SET UP FOR PREPARATION FOR STEMI (EMERGENCY) PATIENT, SYRINGE AND MANIFOLD WOULD NOT CONNECT PROPERLY AND SYRINGE WAS SCREWING BACK ON ITSELF DELAYING SET UP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433305 ↗