Sensica UO SystemRecalls & reported problems across all models

We found 6 models of Sensica UO System by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 348 adverse event reports in the FDA's MAUDE database, received between May 20, 2021 and Feb 5, 2026 — classified as 3 injuries, 345 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (83 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Sensica UO System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 15, 2023Open, Classified

   BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.

   Z-0554-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 19, 2022Open, Classified

   Complaints relating to urine output measurement accuracy.

   Z-1293-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Sensica UO System problems

Sensica UO System models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sensica UO System SCCS1002

  URINOMETER, ELECTRICAL
  2 recalls289 reports
• Sensica UO System SCCS1002E

  URINOMETER, ELECTRICAL
  42 reports
• Sensica UO System SCCS1001

  URINOMETER, ELECTRICAL
  6 reports
• Sensica UO System SSPK1025

  URINOMETER, ELECTRICAL
  4 reports
• Sensica UO System SBTC1005

  URINOMETER, ELECTRICAL
  4 reports
• Sensica UO System SBTS1001

  URINOMETER, ELECTRICAL
  3 reports

Recent Sensica UO System adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJan 28, 2026Volume Accuracy Problem

  IT WAS REPORTED THAT THE RCC RECEIVED A COMPLAINT VIA PHONE. CUSTOMER STATING THEIR SENSICA DEVICE, THE PLASTIC CAP COVER THAT LOCATED BEHIND THE RING OF IT SENSICA WAS PULLED OFF AND DISLODGED. WHEN THE SENSICA DRAINAGE BAG THAT WAS HOOKED ON TO THE FRONT OF THE DEVICE WAS TOO TALL AND URINE BACKFLOWING. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 30JAN2026, BD IS GOING TO REPLACE THE BROKEN UNITS FREE OF CHARGE. THEY ARE WAITING FOR CS TO ADVISE ON NEXT STEPS. 4 BOXES WILL BE SHIPPED FOR THEIR RETURN, FIX THEM, AND SEND THEM BACK. PROBABLY A 3 WEEK PROCESS. THEY HAVE 3 MORE UNITS THAT WERE EXPERIENCING SOFTWARE ISSUES AND THEY ARE TRYING REALLY HARD TO WORK ON THEN THIS WEEK. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 02FEB2026, PROVIDED LIST OF THE BROKEN SENSICA'S, SN (B)(6) RING CAP MISSING. SN (B)(6) RING CAP MISSING. SN (B)(6) RING CAP MISSING AND CAP ATTACHMENT BROKEN. SN (B)(6) MONITOR BROKEN OFF AND HANGING FROM BY THE WIRES. SN (B)(6) ONE OF THE FOUR CONTACTS ON THE RING INTERFACE WERE DAMAGED. THE OTHER 2 HAD SOFTWARE ISSUES. THEY WERE TESTED BY BIOMED AND IT WAS DETERMINED THEY WORK PROPERLY. BIOMED PUT THEM BACK IN SERVICE ON THE NURSING UNIT. ASKING WHETHER TH

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

  MAUDE report 24206106 ↗
• 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 ↗
• MalfunctionAug 26, 2025Nonstandard Device; Computer Operating System Problem; Nonstandard Device; Computer Operating System Problem

  IT WAS REPORTED THAT THE POWER LIGHT, LIGHTS UP BUT THE DISPLAY REMAINS DARK IN THE SENSICA DEVICE.

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

  MAUDE report 22894697 ↗
• MalfunctionAug 21, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SENSICA DEVICE DISPLAYED 4AM AS THE PREVIOUS HOUR EVEN THOUGH IT WAS NEARLY 10AM THERE ON THE CLOCK. ONLY THE TOTAL VOLUME WAS DISPLAYED AND THE OUTPUT FROM 4AM ON WAS BEING DISPLAYED UNDER CURRENT HOUR. THEY STATED THAT THE ORIGINAL NURSE THAT REPORTED THIS REMOVED THE BAG FROM THE RING FIRST TO CLEAN THE PATIENT AND AFTER RETURNING THE BAG THE PREVIOUS HOUR NEVER CHANGED TO THE NEXT HOUR AND STAYED AT 4AM. NURSE ORIGINALLY REPORTED AT 4AM. PER REVIEW OF WO NOTES ON 18AUG2025, THAT ISSUE OCCURRED DURING THE BAG REMOVAL AND RETURN PROCESS. CUSTOMER COULD NOT CONFIRM IF THE BAG WAS MOVED OR REMOVED DURING THE STABILIZATION PROCESS. NURSE WILL START A NEW SESSION AND CALL BACK IF THE ISSUE RETURNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860922 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SENSICA DEVICE DID NOT SHOW THE PREVIOUS HOUR AFTER 10 AM EVEN THOUGH, IT WAS CURRENTLY 1PM. IT SHOWED THE PREVIOUS 3 HOURS OF OUTPUT UNDER THE 10 AM HOUR.

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

  MAUDE report 22318291 ↗
• MalfunctionJun 23, 2025Failure to Power Up; Defective Component; Failure to Power Up; Defective Component

  IT WAS REPORTED THAT THEY EMAILED, THEY HAVE A SENSICA DEVICE, SN: (B)(6). THAT CAN ONLY MAINTAIN 10 MINUTES OF BATTERY LIFE. PER REVIEW OF WO, BIOMED SAYS THE DEVICE ONLY STAYS ON AFTER BEING UNPLUGGED FOR 10MINS. PLEASE FUNCTIONALLY VERIFY THE DEVICE AND IF THEY CAN TEST THAT IT REMAINS ON AFTER BEING UNPLUGGED FOR THE FULL 60 MIN COUNTDOWN.

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

  MAUDE report 22307124 ↗
• MalfunctionJun 12, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE HAVE SEEN SOME ERROR ARISE ON THE SENSICA URINE OUTPUT SYSTEM A COUPLE OF TIMES AND WAS WONDERING IF KNEW WHY OR HOW TO FIX IT. RANDOMLY DURING A SHIFT, IT WOULD STOP SHOWING THE HOURLY OUTPUTS AND COMBINE 3 OR MORE HOURS OF OUTPUT, SO THEY WOULD NOT SEE WHAT THEY PUT OUT EACH HOUR. PER UNIT NURSE MANAGER, NO HARM OCCURRED TO PATIENT. BEDSIDE RN STOPPED THERAPY, RESTARTED DEVICE, AND RESUMED THERAPY WOULD WITHOUT ISSUE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 30JUN2025, THEY WERE SURE WHICH ONE WAS DOING IT SO THEY COULD NOT SEND IT. THEY HAVE NOT EXPERIENCED THE ISSUE SINCE THEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195623 ↗
• MalfunctionJun 12, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE HAVE SEEN SOME ERROR ARISE ON THE SENSICA URINE OUTPUT SYSTEM A COUPLE OF TIMES AND WAS WONDERING IF KNEW WHY OR HOW TO FIX IT. RANDOMLY DURING A SHIFT, IT WOULD STOP SHOWING THE HOURLY OUTPUTS AND COMBINE 3 OR MORE HOURS OF OUTPUT, SO THEY WOULD NOT SEE WHAT THEY PUT OUT EACH HOUR. PER UNIT NURSE MANAGER, NO HARM OCCURRED TO PATIENT. BEDSIDE RN STOPPED THERAPY, RESTARTED DEVICE, AND RESUMED THERAPY WOULD WITHOUT ISSUE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON (B)(6) 2025, THEY WERE SURE WHICH ONE WAS DOING IT SO THEY COULD NOT SEND IT. THEY HAVE NOT EXPERIENCED THE ISSUE SINCE THEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194242 ↗
• MalfunctionJun 5, 2025Computer Operating System Problem; Device Handling Problem; Computer Operating System Problem; Device Handling Problem

  IT WAS REPORTED THAT THE CUSTOMER EMAILED THAT THE SENSICA URINE OUTPUT DEVICE KEPT REBOOTING DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151621 ↗
• MalfunctionMay 14, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE TUBE SENSOR WAS NOT ABLE TO DETECT THE PRESENCE OF THE CATHETER TUBING IN AN SENSICA DEVICE.

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

  MAUDE report 22019835 ↗
• MalfunctionApr 23, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PROBLEM STATED BY THE RN STAFF WAS THAT THE SENSICA URINE OUTPUT DEVICE WAS NOT STABILIZED TO READ THE URINE OUTPUT. THEY CHECKED FOR ANY DAMAGE ON THE THREE PRONG CONNECTORS WHERE THE O RING CONNECTS TO AND THEY DID NOT LOOK DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893137 ↗
• MalfunctionApr 22, 2025Device Sensing Problem; Component Misassembled; Device Sensing Problem; Component Misassembled

  IT WAS REPORTED THAT THE PROBLEM STATED WAS THE SENSICA URINE OUTPUT SYSTEM DID NOT READ THE TUBING IN THE SENSOR ON THE SIDE. THE FRONT 3 PINS LOOK GOOD ON THIS UNIT IN THE FRONT WHERE THE O RING CONNECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886772 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports