Sensica UO System SBTC1005Recalls & reported problems
C. R. Bard, Inc. · Sensica UO System Temperature Sensor Cable · Class 2
All models of Sensica UO System (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741215742), received between Feb 17, 2022 and Mar 7, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (4 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.
Most reported problems
Device problems
- Device Sensing Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2022Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE TEMPERATURE WAS REPORTED TO BE READING HIGH ON THE SENSICA DEVICE. LATER, IT WAS RECORDED TO ONLY BE DISPLAYING ¿***¿ IN PLACE OF THE TEMPERATURE VALUE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13684144 ↗MalfunctionMar 4, 2022Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE TEMPERATURE VALUE WAS SHOWING ASTERISKS IN THE SENSICA UNIT, AND THE PREVIOUS HOUR READINGS WERE LOW. IT WAS STATED THAT WHEN THE USER WAS SQUEEZING OR BENDING THE CABLE AT MOLEX CONNECTOR MOLDING ON THE TEMPERATURE CABLE BY SPINNING IT AROUND, THE TEMPERATURE RECORDED ON THE SENSICA WOULD FLUCTUATE BY SEVERAL DEGREES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13667516 ↗MalfunctionFeb 17, 2022Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE SENSICA UNIT WAS DISPLAYING ASTERISKS FOR TEMPERATURE OUTPUT RATHER THAN AN ACTUAL TEMPERATURE VALUE. IT WAS MENTIONED THAT THIS WAS CAUSED BY THE TEMPERATURE CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13548571 ↗MalfunctionFeb 17, 2022Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE SENSICA SYSTEM WAS DISPLAYING ASTERISKS FOR THE TEMPERATURE OUTPUT VALUE. IT WAS MENTIONED THAT THIS WAS CAUSED BY THE TEMPERATURE CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13548570 ↗
Other URINOMETER, ELECTRICAL devices
- Sensica UO System SCCS1002C. R. Bard, Inc. · URINOMETER, ELECTRICAL2 recalls289 reports
- Sensica UO System SCCS1002EC. R. Bard, Inc. · URINOMETER, ELECTRICAL42 reports
- Bard® CritiCore® Monitor 000002NC. R. Bard, Inc. · URINOMETER, ELECTRICAL42 reports
- Sensica UO SCCS-1001Adaptec Medical Devices LLC · Urinometer, Electrical7 reports
- Sensica UO System SCCS1001C. R. Bard, Inc. · URINOMETER, ELECTRICAL6 reports
- Sensica UO System SSPK1025C. R. Bard, Inc. · URINOMETER, ELECTRICAL4 reports
- Sensica UO System SBTS1001C. R. Bard, Inc. · URINOMETER, ELECTRICAL3 reports
- Bard® Uros™ Precision Urine Output and Temperature Monitor BK10001MC. R. Bard, Inc. · URINOMETER, ELECTRICAL2 reports
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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