Level 1 STS-400Recalls & 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 30695085000116), received between Dec 26, 2025 and Dec 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K864195); 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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Localized Skin Lesion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PROBE TENDED TO TEAR AT THE END, LEAVING THE WIRE EXPOSED, WHICH COULD LEAD TO SKIN INJURIES IN PREMATURE INFANTS. IN THE CASE DESCRIBED, AN INJURY OCCURRED ON THE SOLE OF THE FOOT. THE SITE WAS REPORTEDLY CHANGED ONCE PER DAY. DURING ONE SUCH CHANGE, THE HEAD OF THE PROBE HAD TORN OFF. THIS HAD GONE UNNOTICED, AND THE WIRE HAD THEN BEEN ADHERED TO THE SOLE OF THE FOOT. ACCORDING TO THE REPORT, THIS LED TO A SMALL OPEN SKIN LESION (APPROX. 1×2 CM). IT WAS STATED THAT THE PREMATURE INFANT WAS BEING TREATED IN THE PEDIATRIC INTENSIVE CARE UNIT. THEY REPORTED THAT THE SKIN LESION HAD BEEN TREATED WITH BEPANTHEN CREAM. THE SKIN HAD HEALED QUICKLY, AND THE PREMATURE INFANT WAS SAID TO BE DOING WELL.
Patient problems: Localized Skin Lesion
MAUDE report 23896297 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K864195. One submission often covers many models, so check the product and lot details in each record.
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- Temperature Probes Esophageal/Rectal Temperature ProbePhilips Medical Systems Hsg · Thermometer, electronic, clinical1 recall1 report
- CARESCAPE B450 MBA313GE Healthcare Finland Oy · Thermometer, electronic, clinical1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.