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Level 1 PF-1Recalls & reported problems

Icu Medical, Inc. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20695085400100), received between Feb 24, 2023 and Feb 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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

Device problems

  • Deflation Problem1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 24, 2023Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

    IT WAS REPORTED THAT ONE CHAMBER OF THE FILTER IS DEFLATED IN AN INTACT PACKAGE WHILE IT WAS QUARANTINED AND NOT BEING UTILIZED. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16437385 ↗

Other DEVICE, WARMING. BLOOD AND PLASMA devices

All DEVICE, WARMING. BLOOD AND PLASMA devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.