Mon-a-Therm 90045 (UDI 10884521817548)Recalls & reported problems
Covidien LP · Skin Temperature Probe 400TM · Class 2
All models of Mon-a-Therm (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521817548), received between Nov 13, 2024 and Mar 11, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Low Readings” (3 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Low Readings3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Low Readings
IT WAS REPORTED THAT THE SKIN SENSOR DISPLAYED TEMPERATURE READINGS BELOW THE ACTUAL TEMPERATURE WHICH IS 33-34 DEGREES CELSIUS. THE HOSPITAL TESTED THE SKIN SENSORS ON DIFFERENT STAFF MEMBERS, ON DRY SKIN AND VARIOUS PLACEMENTS, TO CONFIRM THE ISSUE. THE CABLE USED WAS THE SAME AS THAT USED FOR ESOPHAGUS SENSORS AND WAS BELIEVED TO BE FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571726 ↗MalfunctionNov 25, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE SKIN TEMPERATURE SENSORS WERE EVALUATED ALONG WITH URINARY CATHETERS WITH TEMPERATURE SENSORS. IT SHOWED TEMPERATURES THAT WERE TOO LOW, IT WAS 2°C LOWER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773435 ↗MalfunctionNov 13, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, THE SKIN TEMPERATURE SENSORS WERE EVALUATED ALONG WITH FOLEY CATHETERS WITH TEMPERATURE SENSORS. ALL FAULTY SENSORS SHOWED TEMPERATURES THAT WERE TOO LOW, WITH MOST READINGS BEING 1-1.5°C LOWER, AND SOME EVEN 2°C LOWER, INCLUDING ONE SPECIFIC SENSOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20678102 ↗
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- CARESCAPE B450 MBA313GE Healthcare Finland Oy · Thermometer, electronic, clinical1 recall1 report
- Temperature Probes Esophageal/Rectal Temperature ProbePhilips Medical Systems Hsg · Thermometer, electronic, clinical1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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