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Level 1 Y-INJRecalls & reported problems

Icu Medical, Inc. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30695085403108), received between Aug 22, 2022 and Oct 20, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT FAILURE OF DISPOSABLE TUBING OCCURRED DURING INFUSION. THERE WAS NO PATIENT OR CLINICIAN INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15639783 ↗
  • MalfunctionAug 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT MALE PART OF THE LURE CONNECTOR DETACHED AND BECAME STUCK IN PATIENTS CENTRAL LINE. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15272093 ↗

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.