MATRIX12 M Esophageal Temperature Probe CS-31EPRecalls & reported problems
CIRCA Scientific, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10851498007135), received between Mar 28, 2025 and Aug 27, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Sharp Edges” (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. 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
- Sharp Edges1
- Use of Device Problem1
Patient problems
- Unspecified Tissue Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2025Sharp Edges; Sharp Edges
UPON REMOVAL, THERE WAS BLOOD, AND THE PROBE TIP WAS MISSING. ADDITIONALLY, THE SAME PROBE REACHED A HIGH TEMPERATURE ON ONE OF THE CHANNELS BEFORE THE TEMPERATURE BAR DISAPPEARED. THE SAME ISSUE OCCURRED WITH A SECOND SENSOR.
Patient problems: Unspecified Tissue Injury
MAUDE report 22905560 ↗InjuryMar 28, 2025Use of Device Problem; Use of Device Problem
ANESTHESIA STATED DIFFICULT PLACEMENT WITH MATRIX12 M PROBE. PROBE THOUGHT TO BE IN ESOPHAGUS, DEPLOYED AND PLACEMENT FOUND TO BE IN BRONCHIAL STEM. BLEEDING OCCURRED. NOTHING UNUSUAL ABOUT ANATOMY ACCORDING TO ANESTHESIA & STAFF. THE LAB ALSO STOCKS S-CATH M. THIS WAS USED AFTER MATRIX12 M WAS REMOVED. THEY EXTUBATED SUCCESSFULLY AFTER THE CASE WAS FINISHED USING S-CATH M.
Patient problems: Unspecified Tissue Injury
MAUDE report 21724964 ↗
Other Thermometer, Electronic, Clinical devices
- Welch Allyn, Inc. 901054Welch Allyn, Inc. · Thermometer, electronic, clinical1 recall221 reports
- Welch Allyn, Inc. 901054Welch Allyn, Inc. · Thermometer, electronic, clinical2 recalls13 reports
- NA B105 VSP3.0 Patient MonitorGE Medical Systems Information Technologies, Inc. · Thermometer, electronic, clinical2 recalls0 reports
- Medline MDSTH1002Medline Industries, Inc. · Thermometer, electronic, clinical65 reports
- Mon-a-Therm 90050Covidien LP · Thermometer, electronic, clinical1 recall3 reports
- Mon-a-Therm 90044Covidien LP · Thermometer, electronic, clinical1 recall2 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page