Stopcocks 041220001ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333201440), received between Jun 24, 2021 and Jun 24, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2021Leak/Splash

  UNCONTROLLED LEAKING FROM STOPCOCK. STOPCOCK WAS BEING USED TO INFUSE VASOPRESSORS. PATIENT¿S BLOOD PRESSURE DROPPED TO 60S/40S AND THE NURSE KEPT INCREASING THE IV INFUSION RATE NOT REALIZING THE STOPCOCK WAS LEAKING. STOPCOCK HAD TO BE REPLACED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 12061702 ↗

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