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Level 1 SWU-2011Recalls & reported problems

Icu Medical, Inc. · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586043406), received between Dec 1, 2022 and Dec 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Excessive Heating” (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

  • Excessive Heating1

Patient problems

  • Burn(s)1

Recent adverse event reports

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

  • InjuryDec 1, 2022Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT WHEN THE CUSTOMER WAS PERFORMING A SURGICAL OPERATION WITH THE PRODUCT WARMED, A SKIN BURN OCCURRED ON THE PATIENT. THE CLINICIAN SUSPECTED THAT DIRECT APPLICATION OF THE PRODUCT TO THE SKIN CAUSED THE EVENT TO OCCUR.

    Patient problems: Burn(s)

    MAUDE report 15893396 ↗

Other System, thermal regulating devices

All System, thermal regulating devices →

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