Sensica UO System SCCS1002ERecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741219016), received between May 20, 2021 and Feb 5, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (12 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

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Volume Accuracy Problem

  IT WAS REPORTED THAT THE SALES REPRESENTATIVE STATED THAT THE SENSICA DEVICE WAS NOT MEASURING FLUIDS PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268761 ↗
• MalfunctionSep 9, 2025Nonstandard Device; Calibration Problem; Nonstandard Device; Calibration Problem

  IT WAS REPORTED THAT THE PER WO EVALUATION, THE SENSICA URINE OUTPUT DEVICE BODY CONTROL MODULE (BCM) WAS UNABLE TO PASS THE SCREEN CALIBRATION PORTION OF SOFTWARE UPGRADE. NEEDS NEW BODY CONTROL MODULE (BCM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008810 ↗
• MalfunctionJun 24, 2025No Display/Image; Computer Operating System Problem; No Display/Image; Computer Operating System Problem

  IT WAS REPORTED THAT THE BD CLINICAL MANAGER CALLED AND STATED THAT THE SENSICA DEVICES HOUR DISPLAY WAS FROZEN ON THE PREVIOUS 3 HOURS AND DID NOT UPDATE TO REFLECT THE CURRENT HOUR. THE ML WAS STILL READING CORRECTLY AND ACCURATELY BUT THE HOUR DISPLAY WAS FROZEN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320819 ↗
• MalfunctionOct 3, 2023Defective Component; Failure to Calibrate; Defective Component; Failure to Calibrate

  THE SENSICA URINE OUTPUT SYSTEM TOUCHSCREEN NEED UPDATE, AND FAILED THE DURING SCREEN CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860088 ↗
• MalfunctionSep 25, 2023Defective Component; Failure to Calibrate; Defective Component; Failure to Calibrate

  IT WAS REPORTED THAT THE SENSICA URINE OUTPUT SYSTEM TOUCHSCREEN NEED UPDATE AND FAILED BCM DURING CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807493 ↗
• MalfunctionSep 19, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THERE WAS A DEFECT INSIDE FRONT INTERFACE HOUSING ON THE SENSICA DEVICE. PER SAMPLE EVALUATION RESULTS RECEIVED ON (B)(6) 2023, IT WAS REPORTED THAT THE GASKET FOAM NEEDED TO BE APPLIED TO OPTICAL SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772996 ↗
• MalfunctionAug 30, 2023Circuit Failure; Defective Component; Circuit Failure; Defective Component

  IT WAS REPORTED THAT THE SENSICA URINE OUTPUT SYSTEM FAILED SR-03-6469-0002 STEP 8 METAL STAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649625 ↗
• MalfunctionAug 24, 2023Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE TOUCH SCREEN OF THE SENSICA DEVICE WAS UNRESPONSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611414 ↗
• MalfunctionAug 17, 2023Circuit Failure; Defective Component; Circuit Failure; Defective Component

  IT WAS REPORTED THAT THE SENSICA URINE OUTPUT DEVICE WAS CHECKED IN AND NO PHYSICAL DAMAGE PRESENT. THE DEVICE FAILED HI-POTS TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17566088 ↗
• MalfunctionAug 3, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE GASKET FOAM NEEDS TO BE ADDED TO OPTICAL SENSOR OF THE SENSICA DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452511 ↗
• MalfunctionAug 1, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE GASKET FOAM NEEDS TO BE APPLIED TO OPTICAL SENSOR ON THE SENSICA DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435268 ↗
• MalfunctionJul 28, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THEY ADDED GASKET FOAM TO OPTICAL SENSOR FOAM ON THE OF THE SENSICA DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413145 ↗
• MalfunctionJul 28, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE GASKET FOAM NEEDS TO BE APPLIED TO OPTICAL SENSOR OF THE SENSICA DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412927 ↗
• MalfunctionJul 27, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE GASKET FOAM NEEDS TO BE APPLIED TO OPTICAL SENSOR ON THE SENSICA DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17408340 ↗
• MalfunctionJul 27, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE GASKET FOAM NEEDS TO BE ADDED TO OPTICAL SENSOR OF THE SENSICA DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17408073 ↗
• MalfunctionJul 27, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE GASKET FOAM NEEDS TO BE APPLIED. THE FRONT INTERFACE HOUSING IN THE INSIDE OF THE PART HAD A STRIPPED HOLE ON THE SENSICA DEVICE. PER SAMPLE EVALUATION RESULTS RECEIVED ON 06APR2023, IT WAS REPORTED THAT THE FRONT INTERFACE HOUSING IN THE INSIDE OF THE PART (RM0301281) HAD A STRIPPED HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405678 ↗
• MalfunctionJul 11, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE SENSICA DEVICE WAS CHECKED AND THERE WAS NO PHYSICAL DAMAGE PRESENT. PER EVALUATION FINDINGS, LOAD CELL ASSEMBLY NEEDS TO BE REPLACED AND GROUND WIRE REPLACED BECAUSE THE MONITOR KEPT GIVING INCORRECT URINE OUTPUT (UO) READING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299201 ↗
• MalfunctionJul 7, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE SENSICA DEVICE WAS CHECKED AND THERE WAS NO PHYSICAL DAMAGE PRESENT. PER EVALUATION FINDINGS, LOAD CELL ASSEMBLY NEEDS TO BE REPLACED AND GROUND WIRE REPLACED BECAUSE THE MONITOR KEPT GIVING INCORRECT URINE OUTPUT (UO) READING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278153 ↗
• MalfunctionApr 27, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SENSICA DEVICE WAS VERY INCONSISTENT IN ITS RESPONSE TO TOUCH. IT HAD TOUCHSCREEN ISSUES. PER INFORMATION RECEIVED FROM CUSTOMER ON 17APRIL23, UNIT WAS IN BD CONTROL AND WAS MARKED AS EVALUATION UNIT AND ISSUE WAS FOUND DURING TESTING AND WAS NOT USED ON HUMAN TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823063 ↗
• MalfunctionApr 11, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE OPTICAL SENSOR MISALIGNED ON THE SENSICA URINE OUTPUT SYSTEM. PER SAMPLE EVALUATION RESULTS RECEIVED ON 26MAY2023, IT WAS REPORTED THAT THE LOAD CELL GROUNDING WIRE NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712689 ↗
• MalfunctionMar 23, 2023Device Sensing Problem; Component Misassembled; Device Sensing Problem; Component Misassembled

  IT WAS REPORTED THAT THE OPTICAL SENSOR MISALIGNED, SENSICA DEVICE WAS READING ACTUATED WHEN NO TUBE WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16597428 ↗
• MalfunctionMar 23, 2023Device Sensing Problem; Component Misassembled; Device Sensing Problem; Component Misassembled

  IT WAS REPORTED THAT THE OPTICAL SENSOR IN SENSICA DEVICE WAS CONSTANTLY READING ACTUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16597256 ↗
• MalfunctionFeb 21, 2023Device Sensing Problem; Component Misassembled; Device Sensing Problem; Component Misassembled

  IT WAS REPORTED THAT THE OPTICAL SENSOR FAILED IN THE SENSICA DEVICE AND IT READS OPEN WHEN A TUBE WAS PRESENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16408721 ↗
• MalfunctionFeb 9, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE USER SET UP THE SENSICA SYSTEM, DID NOT ADD FLUID AND DID NOT DISTURB THE SYSTEM. IN THE FIRST HOUR, THE SYSTEM READ 7ML AND THE SECOND HOUR IT READ 3ML. THIS WAS OUTSIDE OF THE ACCURACY SPECIFICATION THAT MSS WOULD EXPECT WHEN THE SYSTEM WAS NOT BEING DISTURBED. AS PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 31JAN2023, THEY HAVE DECIDED TO KEEP THE SENSICA AND WOULD CONTINUE TO MONITOR THIS UNIT FOR ISSUES. IF THESE ISSUES CONTINUE, THEY WOULD SEND IT FOR EVALUATION AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334889 ↗
• MalfunctionJan 31, 2023Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE DURING THE EXECUTION OF FIELD ACTION, THE TOUCHSCREEN CALIBRATION FAILED. SENSICA MIGHT REQUIRE NEW BCM TOUCHSCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272560 ↗