Sensica UO System SCCS1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741215612), received between Feb 26, 2022 and Aug 13, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Volume Accuracy Problem” (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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE PATIENT WAS MOBILIZED TO A CHAIR SHORTLY BEFORE SHIFT CHANGE AS WAS TYPICAL FOR THE SENSICA URINE OUTPUT UNIT, AND WHEN THEY WENT IN FOR OUR SHIFT CHANGE DRIP CHECK, THEY COULD SEE THAT THE HEIGHT OF THE FOLEY BAG WAS JUST ABOUT LEVEL WITH MY PATIENT'S BLADDER LEVEL WHEN SEATED IN THE CHAIR. THERE WAS A SMALL AMOUNT OF URINE IN THE LINE, BUT NONE IN THE CHAMBER. WHEN THEY WENT IN AT 8 TO GET HOURLY MEASUREMENTS, THEY NOTICED THAT NONE OF THE URINE WAS ABLE TO MAKE IT TO THE BAG. SO REMOVED IT TO ALLOW THE URINE TO FLOW INTO THE CHAMBER AND CHARTED THE REMOVAL AND MY REASONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794605 ↗
• MalfunctionMar 2, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ON FEBRUARY 8, AN REGISTERED NURSE PROVIDED FEEDBACK TO THE SENSICA REIMPLEMENTATION SURVEY THAT ALLEGED DEFICIENCIES RELATED TO THE DEVICE PERFORMANCE AND SAFETY. THE REGISTERED NURSE RESPONDED THAT THE SENSICA URINE OUTPUT SYSTEM DID NOT MEASURE CORE BLADDER TEMPERATURE WITHIN THE SPECIFICATIONS OF THE INSTRUCTIONS FOR USE (+ OR -0.2 DEGREES C OR + OR -0.4 DEGREES F) WHEN COMPARED TO SWAN MEASUREMENTS. THE REGISTERED NURSE DOCUMENTED THAT THE SENSICA CORE BODY TEMPERATURE WAS 0.5 DEGREES F HIGHER THAN THE SWAN MEASURED TEMPERATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475487 ↗
• MalfunctionMar 2, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT ON FEBRUARY 8, A REGISTERED NURSE PROVIDED FEEDBACK TO THE SENSICA REIMPLEMENTATION SURVEY THAT ALLEGES DEFICIENCIES RELATED TO THE DEVICE PERFORMANCE AND SAFETY. THE REGISTERED NURSE RESPONDED THAT THE SENSICA URINE OUTPUT SYSTEM DID NOT MEASURE URINE OUTPUT WITHIN THE SPECIFICATIONS OF THE INSTRUCTION FOR USE FOR TWO HOURS OVER THE COURSE OF A 12-HOUR SHIFT WHEN COMPARED TO MANUAL UROMETER MEASUREMENTS. CASE 1 WAS SENSICA READ 406ML, UROMETER READ 335ML (22 PERCENT ABOVE THE UROMETER READING) CASE 2 WAS SENSICA READ 341ML, UROMETER READ 360ML (5.3 PERCENT BELOW THE UROMETER READING) ADDITIONALLY, THE REGISTERED NURSE NOTED THAT THE SENSICA FOLEY TRAY TUBING DID NOT DRAIN WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475444 ↗
• MalfunctionMar 2, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT ON (B)(6) AN REGISTERED NURSE PROVIDED FEEDBACK TO THE SENSICA REIMPLEMENTATION SURVEY THAT ALLEGED DEFICIENCIES RELATED TO THE DEVICE PERFORMANCE AND SAFETY. THE REGISTERED NURSE RESPONDED THAT THE SENSICA URINE OUTPUT SYSTEM DID NOT MEASURE URINE OUTPUT WITHIN THE SPECIFICATIONS OF THE INSTRUCTION FOR USE FOR TWO HOURS OVER THE COURSE OF A 12 HOUR SHIFT WHEN COMPARED TO MANUAL UROMETER MEASUREMENTS. CASE 1 WAS SENSICA READ 406ML, UROMETER READ 335ML (22 PERCENT ABOVE THE UROMETER READING) CASE 2 WAS SENSICA READ 341ML, UROMETER READ 360ML (5.3 PERCENT BELOW THE UROMETER READING). ADDITIONALLY, THE REGISTERED NURSE NOTED THAT THE SENSICA FOLEY TRAY TUBING DID NOT DRAIN WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16467218 ↗
• MalfunctionJul 28, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE PHANTOM ADDED 11MLS DURING THE DEMO WAS A CONCERN IN THE SENSICA DEVICE. MULTIPLE BD REPRESENTATIVES WERE THERE WHEN THIS OCCURRED, AND THIS CAUGHT US ALL BY SURPRISE. THERE WERE MIXED REVIEWS FROM THE TEAM THAT WITNESSED THIS WHERE THEY WERE CERTAIN THE SYSTEM WAS AT REST WITH NOTHING TOUCHING IT OR GOING INTO THE BAG WHEN 11MLS SHOWED UP AS ADDED URINE OUTPUT. THIS COULD HAVE BEEN A SITUATION WHERE WE HAD A FINICKY DEVICE BUT THIS SEEMED ALL TOO COMMON WITH THE PREVIOUS EXPERIENCES WE¿VE HAD WITH SENSICA SO WE CONCLUDED THAT FURTHER TESTING NEEDS TO BE OBSERVED IN SITUATIONS THAT INCLUDE TESTING SENSICA AT REST BUT ACTUALLY TREATING IT LIKE NURSES DO IN THE INTENSIVE CARE UNIT AND MOVING IT FROM ONE SIDE OF THE BED TO ANOTHER, TRANSITIONING THEM FROM BED TO CHAIR AND SEE IF THE DEVICE ONLY ADDED URINE OUTPUT IN THESE SITUATIONS VERSES WHAT WE HAVE SEEN LIKE THIS INSTANCE THAT HAD HAPPENED BEFORE WHICH WAS PHANTOM ADDITIONS OF URINE BEING ADDED TO THE HOURLY OUTPUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121648 ↗
• MalfunctionFeb 26, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE SENSICA DEVICE DID NOT RECOGNIZE THE BAG. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2022, THE DEVICE WAS NOT USED ON THE PATIENT AND WOULD BE SENT IN FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13614954 ↗