Sensica UO System SCCS1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 289 adverse event reports that list this exact device (DI 00801741215773), received between Dec 12, 2021 and Jan 28, 2026 — classified as 3 injuries, 286 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (70 reports).

2 FDA recall records name this device's 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, 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.

Recalls naming this device

1. Nov 15, 2023Class IIOpen, 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, 2022Class IIOpen, Classified

   Complaints relating to urine output measurement accuracy.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 289 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 4, 2025Use of Device Problem; Computer Operating System Problem; Use of Device Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE SENSICA URINE OUTPUT SYSTEM WAS RESTARTING DURING USE. THERE WAS A DAMAGED LOAD CELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516799 ↗
• MalfunctionJan 9, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE SENSICA URINE OUTPUT SYSTEM WAS SENT TO BIOMED AS NOT BEING ACCURATE. DEVICE WOULD BE SENT TO THE DEPOT FOR ASSESSMENT OF ACCURACY LOAD CELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114499 ↗
• MalfunctionDec 13, 2024Circuit Failure; Volume Accuracy Problem; Circuit Failure; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BIOMED HAD THE SENSICA DEVICE THAT THE USERS STATED WAS READING SEVERAL HUNDRED ML OVER LIMITS AND THEY ATTEMPTED TO RESET THE SYSTEM, AND THE ISSUE CONTINUED TO REOCCUR, COMING IN FOR SERVICE UNDER WARRANTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925391 ↗
• MalfunctionSep 20, 2024Power Problem; Power Problem

  IT WAS REPORTED THAT THE SENSICA DEVICE DID NOT POWER ON. IN EVALUATION FINDINGS IT HAS BEEN NOTED THAT THE DEVICE WAS RECEIVED IN WITH CRITICAL DAMAGE TO LOAD CELL PINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267628 ↗
• MalfunctionAug 30, 2024Defective Component; Device Sensing Problem; Defective Component; Device Sensing Problem

  IT WAS REPORTED THAT WHEN THE IQVIA TEAM CAME OUT TO PERFORM UPDATES SENSICA URINE OUTPUT SYSTEM FAILED THE OPTICAL SENSOR TEST. OPTICAL SENSOR FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20106601 ↗
• MalfunctionAug 14, 2024Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE BIOMED STATED THAT THE SENSICA URINE OUTPUT DEVICE WAS SENT DOWN TO BIOMED WITH ISSUES STARTING A SESSION. IT WAS DETERMINED THAT THE DEVICE HAD A DAMAGED LOAD CELL WITH PINS POTENTIALLY BENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS LOGGING URINE OUTPUT INCORRECTLY AND TAKING A LONG TIME TO CONNECT TO START ONCE THE URINE BAG WAS CONNECTED. THEY HAVE ASKED FOR MORE TECHNICAL CLARIFICATION REGARDING THIS INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981405 ↗
• MalfunctionAug 14, 2024Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE BIOMED STATED THAT THE SENSICA URINE OUTPUT DEVICE WAS SENT DOWN TO BIOMED WITH ISSUES STARTING A SESSION. IT WAS DETERMINED THAT THE DEVICE HAD A DAMAGED LOAD CELL WITH PINS POTENTIALLY BENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS LOGGING URINE OUTPUT INCORRECTLY AND TAKING A LONG TIME TO CONNECT TO START ONCE THE URINE BAG WAS CONNECTED. THEY HAVE ASKED FOR MORE TECHNICAL CLARIFICATION REGARDING THIS INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980980 ↗
• MalfunctionAug 12, 2024Volume Accuracy Problem; Device Handling Problem; Volume Accuracy Problem; Device Handling Problem

  IT WAS REPORTED THAT THE BIOMED STATED THAT THE SENSICA URINE OUTPUT DEVICE WAS SENT DOWN TO BIOMED WITH ISSUES STARTING A SESSION. IT WAS DETERMINED THAT THE DEVICE HAD A DAMAGED LOAD CELL WITH PINS POTENTIALLY BENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS LOGGING URINE OUTPUT INCORRECTLY AND TAKING A LONG TIME TO CONNECT TO START ONCE THE URINE BAG WAS CONNECTED. THEY HAVE ASKED FOR MORE TECHNICAL CLARIFICATION REGARDING THIS INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19965685 ↗
• MalfunctionAug 12, 2024Volume Accuracy Problem; Device Handling Problem; Volume Accuracy Problem; Device Handling Problem

  IT WAS REPORTED THAT THE BIOMED STATED THAT THE SENSICA URINE OUTPUT DEVICE WAS SENT DOWN TO BIOMED WITH ISSUES STARTING A SESSION. IT WAS DETERMINED THAT THE DEVICE HAD A DAMAGED LOAD CELL WITH PINS POTENTIALLY BENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS LOGGING URINE OUTPUT INCORRECTLY AND TAKING A LONG TIME TO CONNECT TO START ONCE THE URINE BAG WAS CONNECTED. THEY HAVE ASKED FOR MORE TECHNICAL CLARIFICATION REGARDING THIS INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961876 ↗
• MalfunctionAug 8, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ARCTIC SUN DEVICE DOES NOT RECOGNIZE WHEN RING IS ATTACHED. IN EVALUATION FINDINGS, DEVICE WAS RECEIVED IN WITH DAMAGED LOAD CELL. LOAD CELL PINS ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940493 ↗
• MalfunctionJun 4, 2024Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE SENSICA URINE OUTPUT SYSTEM KEPT REBOOTING ON ITS OWN. WOULD BOOT TO THE GREEN PATIENT SCREEN AND THEN POWER CYCLE AND REPEAT. DEVICE WOULD BE SENT TO THE DEPOT FOR ASSESSMENT OF THE TOUCHSCREEN AND INTERNAL COMPONENTS.

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

  MAUDE report 19460043 ↗
• MalfunctionNov 22, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT BIOMED STATED THAT THE SENSICA DEVICE WOULD NOT READ THE RING PORTION OF THE 3-STEP CHECK PROCESS. THEY WERE ON-SITE AND TOLD THE LOAD CELL WOULD READ THE RING INTERMITTENTLY. THEY TRIED WIPING THE LOAD CELL PINS OFF AND GOT THE RING TO READ. DEVICE WOULD BE SENT TO THE DEPOT FOR LOAD CELL REPLACEMENT.

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

  MAUDE report 18192669 ↗
• MalfunctionAug 31, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE BIOMED STATED THE SENSICA DEVICE DID NOT READING THE BAG DURING 3 STEP CHECK AND IT WOULD NOT RECOGNIZED BAG. THE LOAD CELL WAS FAILED.

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

  MAUDE report 17661014 ↗
• MalfunctionAug 25, 2023Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE SENSICA DEVICE WAS AT LEAST AT ONE INSTANCE OF TIME CHANGED. AND THERE WAS 2 HOURS TIME VARIATION APPROXIMATELY. THAT HAPPENED IN THE MIDDLE OF A PATIENT MONITORING SESSION WHICH RESULTED IN INCORRECT TIMESTAMPS DATA OF PATIENT URINE OUTPUT (UO) AND CORE BLADDER TEMPERATURE DATA. AS PER THE COMMUNICATION WITH THE CUSTOMER THAT ISSUE WAS NAVIGATED WITHOUT A CLINICAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622885 ↗