Bard® Extension Cable 153622Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00801741045875), received between Feb 26, 2020 and Feb 25, 2026 — classified as 122 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (89 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026No Display/Image

  IT WAS REPORTED THAT THERE WAS NO TEMPERATURE DISPLAY IN THE TEMPERATURE SENSING FOLEY CATHETER, OR SOMETIMES THERE WAS, BUT A LOW VALUE WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445551 ↗
• MalfunctionJan 17, 2026No Display/Image

  IT WAS REPORTED THAT DURING USE THE CATHETER AND TRAY ACCESSORIES TEMPERATURE WAS NOT DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24105494 ↗
• MalfunctionFeb 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING USE, THE TEMPERATURE DISPLAY OF THE EXTENSION CORD WAS UNSTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375399 ↗
• MalfunctionDec 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE DISPLAY FOR EXTENSION CORD WAS SOMETIMES POSSIBLE AND SOMETIMES NOT POSSIBLE. STATED THAT TEMPERATURE DISPLAY WAS FAILURE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 26NOV2024, CUSTOMER CONFIRMED THAT PATIENT INVOLVEMENT AND 2 PRODUCTS WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912396 ↗
• MalfunctionAug 12, 2024Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  IT WAS REPORTED THAT THERE WAS NO TEMPERATURE DISPLAYED WHEN USING TEMPERATURE SENSOR CABLE. THE TEMPERATURE SENSOR CABLE MIGHT HAVE A PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962657 ↗
• MalfunctionFeb 20, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT BLADDER TEMPERATURE WAS MEASURED USING EXTENSION CORD FOR TEMPERATURE SENSING CATHETER. OUT OF 62, 23 CASES OF TEMPERATURE FAILURE REPORTED BY MEDICAL SAFETY DURING 19 TO 26 DEC. PER CUSTOMER FOLLOW UP RECEIVED ON 02FEB2024, THEY SAID THAT THERE WERE VARIOUS CASES. IN SOME CASES, NOTHING WAS DISPLAYED, WHILE IN OTHERS, TEMPERATURE VALUES THAT WERE CLEARLY WRONG, SUCH AS AROUND 34 DEGREES CELSIUS, WERE SHOWN. THE NUMBER OF EACH CASE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739738 ↗
• MalfunctionNov 16, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT A TEMPERATURE ERROR (TEMPERATURE IS NO LONGER DISPLAYED) OCCURRED DURING BODY TEMPERATURE MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147870 ↗
• MalfunctionOct 31, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE DISPLAYED TEMPERATURE WAS NO STABLE AND WAS FLUCTUATING (2-3 DEGREES CELSIUS) UNNATURALLY AND REPEATEDLY. THE EVENT HAS OCCURRED MULTIPLE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038184 ↗
• MalfunctionOct 26, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE DISPLAYED TEMPERATURE WAS NO STABLE AND WAS FLUCTUATING (2-3 DEGREES CELSIUS) UNNATURALLY AND REPEATEDLY. THE EVENT HAS OCCURRED MULTIPLE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011224 ↗
• MalfunctionOct 6, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE DISPLAY BECAME UNSTABLE DUE TO A POSSIBLE CONNECTION PROBLEM WITH THE MONITOR. THE REPRESENTATIVE COULD NOT CONFIRM THE NUMBER BUT CONFIRMED 13 BLACK CABLES, WHERE 12 ARE CASE BULL TYPE 153622. ONE BOTTLE WAS CONFIRMED TO BE J-SOL. 13 CHECKED FOR THE APPEARANCE OF THE CABLES BUT COULD NOT CONFIRM. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2023, THE CUSTOMER CLARIFIED THAT TOTAL 12 CABLES WERE AFFECTED AND THERE WAS AN ANOTHER PRODUCT MIXED WITH THE 12 CABLES ALREADY REPORTED. THEY CLARIFIED THAT THERE WAS NO FITTING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887142 ↗
• MalfunctionSep 20, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE EXTENSION CORD OF THE TEMPERATURE SENSING CATHETER WAS BROKEN. STATED THAT THE BLADDER TEMPERATURE WAS UNABLE TO BE MEASURED DUE TO THE DISCONNECTION OF LEAD WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780101 ↗
• MalfunctionAug 31, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE DISPLAY WAS INCORRECT. AS PER THE FOLLOW UP INFORMATION RECEIVED VIA IBC ON 22AUG2023, IT WAS NOT REPORTED WHETHER OR NOT IT WAS USED ON THE PATIENT. THE CUSTOMER DID NOT PROVIDE DETAILS IF THERE WAS FITTING PROBLEM.

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

  MAUDE report 17663755 ↗
• MalfunctionAug 14, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT TWO CABLES THAT WERE PURCHASED WERE ERRATIC IN DISPLAYING TEMPERATURES. SOMETIMES THE TEMPERATURE WAS DISPLAYED, AND SOMETIMES IT WAS NOT. THE MONITORS WERE NIHON KOHDEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541996 ↗
• MalfunctionAug 10, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT TEMPERATURES VARIED UP AND DOWN DURING MEASUREMENT WHILE USING THE EXTENSION CORD FOR THE TEMPERATURE SENSING CATHETER. THE PROBLEM CONTINUED TO OCCUR EVEN AFTER REPLACING THE CABLE WITH A NEW ONE. THE MONITOR WAS NIHON KOHDEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497912 ↗
• MalfunctionAug 7, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT TEMPERATURE VARIED UP AND DOWN DURING THE MEASUREMENT WITH TEMPERATURE SENSING CATHETER ON THE NIHON KOHDEN MONITOR. AS PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON 14JUL2023, IT WAS STATED THAT THE THE TEMPERATURE CABLE WAS FOUND TO BE OUT OF DIMENSIONAL SPECIFICATION DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471323 ↗
• MalfunctionJul 5, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT TEMPERATURE WAS NOT DISPLAYED PROPERLY. THE TEMPERATURE DISPLAYED ON THE MONITOR WAS NOT STABLE. THERE ARE 4 OTHERS WITH THE SAME MANUFACTURING NUMBER, AND THEY ARE ALSO RED AND BLACK PROCESSED. AS PER THE FOLLOW UP INFORMATION RECEIVED VIA IBC ON 19JUN2023, THERE WERE 5 SAMPLES FROM THE SAME LOT WERE OF THE SAME ISSUE.

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

  MAUDE report 17260507 ↗
• MalfunctionJun 9, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT TEMPERATURE WAS NOT DISPLAYED WHEN CONNECTED, 50 PERCENT OF THE TIME IT WAS CONNECTED. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON (B)(6) 2023, IT WAS STATED THAT DURING EVALUATION THE SAMPLE WAS FOUND TO NOT MEET DIMENSIONAL REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097441 ↗
• MalfunctionJun 2, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT TEMPERATURE WAS NOT DISPLAYED WHEN CONNECTED, 50 PERCENT OF THE TIME IT WAS CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049662 ↗
• MalfunctionMay 17, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT TEMPERATURE DISPLAY ON THE TEMPERATURE SENSING CATHETER WAS WRONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946583 ↗
• MalfunctionMay 1, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE DISPLAY WAS UNSTABLE SOON AFTER TEMPERATURE SENSING CATHETER WAS STARTED TO USE. THE CABLE WAS DISCONTINUED TO USE AND REPLACED WITH ANOTHER CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843900 ↗
• MalfunctionMay 1, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT TEMPERATURE VARIED UP AND DOWN DURING THE MEASUREMENT WITH TEMPERATURE SENSING CATHETER ON THE NIHON KOHDEN MONITOR. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON 14JUL2023, IT WAS STATED THAT THE THE TEMPERATURE CABLE WAS FOUND TO BE OUT OF DIMENSIONAL SPECIFICATION DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843404 ↗
• MalfunctionApr 28, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT TEMPERATURE WAS NOT PROPERLY DISPLAYED ON MONITOR. WHEN CONNECTING THE 153622 CABLE TO MEASURE THE TEMPERATURE, THE MONITOR DID NOT DISPLAY THE TEMPERATURE. WHEN THE CUSTOMER TRIED AGAIN LATER, IT WAS DISPLAYED, BUT WHEN THEY SLIGHTLY TOUCHED THE CONNECTION BETWEEN THE CATHETER AND THE 153622 CABLE DURING THE DISPLAY, THE TEMPERATURE DISPLAY DISAPPEARED AND THEN REAPPEARED. AS PER THE ADDITIONAL INFORMATION RECEIVED VIA IBC ON 12APR2023, IT WAS REPORTED THAT WHEN THE USER SLIGHTLY TOUCHED THE CONNECTION BETWEEN THE CATHETER AND THE 153622 CABLE DURING THE DISPLAY, THE TEMPERATURE DISPLAY DISAPPEARED AND THEN REAPPEARED. ACCORDING TO THIS STATEMENT, THE FITTING ISSUE BETWEEN THE CATHETER AND THE 153622 CABLE MIGHT HAVE CAUSED THE ERRATIC DISPLAY. HOWEVER, SINCE THE SAMPLE IS NOT AVAILABLE, WE CANNOT CONFIRM WHETHER IT WAS A FITTING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16837342 ↗
• MalfunctionApr 18, 2023Fitting Problem; Component Misassembled; Fitting Problem; Component Misassembled

  IT WAS REPORTED THAT THE TEMPERATURE DISPLAY WAS INCORRECT WHILE USING THE EXTENSION CORD FOR TEMPERATURE SENSING FOLEY CATHETER. THERE WAS POOR MESHING OF CATHETER AND CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16760643 ↗
• MalfunctionApr 12, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE WAS NOT CORRECTLY DISPLAYED. WHEN THE SOCKET WAS FIRMLY FITTED THERE WAS NO PROBLEM, BUT SOMETIMES THE TEMPERATURE WAS NOT DISPLAYED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724515 ↗
• MalfunctionApr 10, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE DISPLAY WAS DEFECTIVE (POOR). PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 16MAY2023, STATED THAT THE DEVICE WAS USED ON THE PATIENTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706818 ↗