Bard® CritiCore® Monitor 000002NRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741080777), received between Aug 10, 2017 and Apr 24, 2020 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Volume Accuracy Problem” (9 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.

• MalfunctionApr 24, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, UPON COMPLETION OF THE INVESTIGATION ON 17JUL2019, THE CRITICORE U5 COMPONENT ON THE DISPLAY PCB WAS BURNED AND THE BACKLIGHT DID NOT GO OUT.

  Patient problems: No Patient Involvement

  MAUDE report 9995152 ↗
• MalfunctionJun 4, 2019Volume Accuracy Problem; Volume Accuracy Problem; Output Problem

  IT WAS REPORTED THAT THE CRITICORE MONITOR WAS NOT COUNTING THE HOURLY OUTPUT CORRECTLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8669259 ↗
• MalfunctionMay 16, 2019Break; Incorrect, Inadequate or Imprecise Result or Readings; Break

  IT WAS REPORTED THAT THE CRITICORE MONITOR WAS NOT READING RIGHT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8617332 ↗
• MalfunctionMay 16, 2019Break; Incorrect, Inadequate or Imprecise Result or Readings; Break

  IT WAS REPORTED THAT THE CRITICORE MONITOR WAS NOT READING CORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8616220 ↗
• MalfunctionMay 14, 2019Unable to Obtain Readings; Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE CRITICORE DEVICE WAS NOT READING VOLUME CORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8607768 ↗
• MalfunctionMay 1, 2019Break; Display or Visual Feedback Problem; Break

  IT WAS REPORTED THAT THERE WAS INTERMITTENT DISPLAY AT THE TEMPERATURE PROBE CONNECTION OF THE CRITICORE DEVICE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8569245 ↗
• MalfunctionMar 28, 2019Erratic or Intermittent Display; Calibration Problem; Erratic or Intermittent Display; Calibration Problem

  PER COMPLETION OF THE INVESTIGATION, IT WAS FOUND THAT THE OBSERVED MEASURED TEMPERATURE WAS READING LOW WHEN THE TEST TEMPERATURE PLUG WAS USED.

  Patient problems: No Patient Involvement

  MAUDE report 8461640 ↗
• MalfunctionFeb 6, 2019Erratic or Intermittent Display; Incorrect, Inadequate or Imprecise Result or Readings; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE CRITICORE DEVICE WAS NOT REGISTERING THE CORRECT TEMPERATURE. THE TEMPERATURE WAS OFF BY 10 DEGREES.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8311188 ↗
• MalfunctionFeb 6, 2019Break; Device Sensing Problem; Break

  IT WAS REPORTED THAT THE CRITICORE DEVICE WAS NOT READING THE TEMPERATURE CORRECTLY. THE READING WAS 10 DEGREES OFF.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8310106 ↗
• MalfunctionJan 30, 2019Break; Loose or Intermittent Connection; Incorrect, Inadequate or Imprecise Result or Readings; Break

  IT WAS REPORTED THAT THE TEMPERATURE PORT HAD A LOSE CONNECTION CAUSING UNSTABLE READINGS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 8290605 ↗
• MalfunctionJan 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE MONITOR WAS INTERMITTENTLY SHOWING ITSELF AS NOT LEVEL, DURING THE EVALUATION OF THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8232825 ↗
• MalfunctionJan 4, 2019Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE MEASURED TEMPERATURE WAS INTERMITTENT.

  Patient problems: No Patient Involvement

  MAUDE report 8216814 ↗
• MalfunctionDec 4, 2018Volume Accuracy Problem; Volume Accuracy Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CRITICORE MONITOR WAS NOT READING THE URINE VOLUME.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8130652 ↗
• MalfunctionOct 24, 2018Circuit Failure; Circuit Failure; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE VOLUME AND THE TEMPERATURE DO NOT READ CORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8002231 ↗
• MalfunctionSep 26, 2018Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE DEVICE DISPLAYED AMBER LIGHTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909618 ↗
• MalfunctionSep 26, 2018Image Display Error/Artifact

  IT WAS REPORTED THAT THE DEVICE WAS BLINKING AMBER LIGHTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909617 ↗
• MalfunctionSep 4, 2018Device Sensing Problem; Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DEVICE WAS NOT READING THE TEMPERATURE NOR RECORDING THE AMOUNT OF OUTPUT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7842680 ↗
• MalfunctionAug 23, 2018Volume Accuracy Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT READ THE VOLUME.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7809832 ↗
• MalfunctionJul 5, 2018Device Displays Incorrect Message; Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AS THE UNIT WAS BEING USED ON A PATIENT, THE NURSE NOTICED THAT DEVICE DISPLAYED 'CHECK CONTAINER'. THE DEVICE DISPLAYED "NOT LEVEL" ALTHOUGH THE DEVICE WAS ON A LEVEL SURFACE. IT WAS ALSO NOTED THAT THE DEVICE DISPLAYED '---' WHEN THE CONTAINER VOLUME KEY WAS PRESSED AND THE TANK HALF FULL.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7663436 ↗
• MalfunctionJun 29, 2018Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING SAMPLE EVALUATION IT WAS FOUND THAT THE THE LCD WAS NOT DISPLAYING ALL SEGMENTS IN THE CONTAINER VOLUME/FLOW RATE QUADRANT.

  Patient problems: No Patient Involvement

  MAUDE report 7652920 ↗
• MalfunctionJun 28, 2018Inaccurate Flow Rate; No Device Output; Data Problem; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE DEVICE WOULD NOT RECORD URINE OUTPUT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7648160 ↗
• MalfunctionMay 10, 2018Volume Accuracy Problem; Incorrect, Inadequate or Imprecise Result or Readings; Volume Accuracy Problem

  IT WAS REPORTED BY THE CLINICAL MANAGER THAT THE DEVICE WAS NOT ACCURATELY READING THE URINE OUTPUT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7502652 ↗
• MalfunctionApr 24, 2018Volume Accuracy Problem; Incorrect Measurement; Volume Accuracy Problem

  IT WAS REPORTED THAT THE DEVICE WAS ON THE PATIENT AND NOT MEASURING URINE CORRECTLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7453655 ↗
• MalfunctionApr 23, 2018Failure to Power Up; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Failure to Power Up

  IT WAS REPORTED THAT THE SCREEN FROZE UPON BOOT UP.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7453098 ↗
• MalfunctionMar 19, 2018Volume Accuracy Problem; Volume Accuracy Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DEVICE WAS NOT READING URINE VOLUME ACCURATELY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7349208 ↗