Stopcocks 041210002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886333201389), received between Dec 5, 2020 and Sep 12, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K780271); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Leak/Splash; Leak/Splash

  REPORTER INDICATED "WHEN DRAWING BLOOD THROUGH DISTAL PORT OF CVC, ABLE TO OBTAIN SMALL AMOUNT OF BLOOD, THEN BUBBLES. WHEN FLUSHING BLOOD BACK INTO CATHETER, LEAK NOTED AT STOPCOCK. LINENS NEAR HEAD NOTED TO BE DAMP AND YELLOW-TINGED, SMALL AMOUNT. STOPCOCK REPLACED; LINE DREW WELL AFTER WITH NO COMPLICATIONS. DEVICE HAD BEEN CHANGED ON AUG 7, SO WAS NOT YET AT THE 96HR MARK TO BE REPLACED. VENOUSE GASES HAD BEEN DRAWN FROM LINE Q12HR FROM AUG 7 TO PRESENT. NO APPARENT HARM NOTED. PATIENT RECEIVED LESS THAN ANTICIPATED AMOUNTS OF INFUSIONS RUNNING THROUGH IJ, INCLUDING TPN, MIDAZOLAM, AND HYDROMORPHONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201334 ↗
• MalfunctionOct 16, 2022Fluid/Blood Leak

  BLOOD IS LEAKING OUT AT STOPCOCK DURING OPEN HEART PROCEDURES MAKING A MESS.

  Patient problems: Insufficient Information

  MAUDE report 15613073 ↗
• InjurySep 26, 2022Fluid/Blood Leak; Fluid/Blood Leak; Leak/Splash; Air/Gas in Device

  OUR 4 WAY STOPCOCK WAS CONNECTED TO THE PATIENT AND THEN TO THE CONTRAST LINE. 3 OCCASION WHERE THE STOPCOCK WOULD CONTINUOUSLY LEAK FROM THE CENTER PORT AND 1 OCCASION WHERE IT SUCKED IN AIR THROUGH THE LINE.

  Patient problems: Insufficient Information

  MAUDE report 15486026 ↗
• MalfunctionJun 3, 2021Crack; Fluid/Blood Leak

  ARGON 4-WAY STOPCOCK WAS CRACKED, CAUSING FLUID TO LEAK FROM IV HOOKUP. NO PATIENT HARM. USED:TUBING /IV SETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930369 ↗
• MalfunctionMay 20, 2021Crack; Fluid/Blood Leak

  6 ARGON CLEAR 4-WAY STOPCOCK NEEDING TO BE CHANGED OUT FOR DIFFERENT MEDEX 4-WAY STOPCOCK W/ SWIVEL MALE LUER LOCK DUE TO LEAKING AT CONNECTION SITES. UNITS APPEAR TO BE CRACKED CAUSING BACKFLOW OF BLOOD INTO IV "TREE". 4 OF THE 6 ARE AVAILABLE FOR RETURN. USED: TUBING/IV SETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856206 ↗
• MalfunctionDec 5, 2020Fluid/Blood Leak

  FOLLOW UP.

  Patient problems: Insufficient Information

  MAUDE report 10950570 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K780271. One submission often covers many models, so check the product and lot details in each record.

• Z-0290-2020 · Oct 16, 2018 · Terminated
  (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 0