Bard® Two Pin Plug, Monitor Cable 153625HRecalls & reported problems
C. R. Bard, Inc. · Bard® Two Pin Plug, Monitor Cable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741045905), received between Aug 15, 2017 and Feb 25, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (7 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.
Reports received per month
Most reported problems
Device problems
- Erratic or Intermittent Display7
- No Display/Image3
- Temperature Problem3
- Fitting Problem2
- Disconnection1
- Image Display Error/Artifact1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- Alteration In Body Temperature1
- No Information1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Fitting Problem
IT WAS REPORTED THAT WHEN CONNECTING THE TEMPERATURE SENSING CABLE TO THE MONITOR, THE CONNECTION WAS LOOSE COMPARED TO THE PHILIPS CABLE WE PREVIOUSLY USED, WHICH MAY HAVE CAUSED INCORRECT TEMPERATURE READINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24445379 ↗MalfunctionAug 20, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE TEMP SENSING EXTENSION CABLE FOR PHILIPS TENDS TO COME OUT EASILY, CAUSING ISSUES DURING THE OPERATION. THE PHYSICIAN WOULD LIKE TO KNOW IF ANY IMPROVEMENTS WILL BE MADE IN THE FUTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22851783 ↗MalfunctionSep 5, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE TEMPERATURE READING WAS HIGH OR LOW DURING MEASUREMENT WHILE USING TEMPERATURE SENSING EXTENSION CORD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20148049 ↗MalfunctionJun 1, 2023No Display/Image; Fitting Problem; No Display/Image; Fitting Problem
IT WAS REPORTED THAT AFTER SEVERAL USES, IT NO LONGER DISPLAYED THE NORMAL TEMPERATURE. THE CRACK IN THE CONNECTOR ON THE SIDE THAT CONNECTED TO THE TEMPERATURE SENSOR CATHETER WAS INTENTIONALLY CUT BY THE HOSPITAL TECHNICIAN TO CHECK THE STRUCTURE OF THE PRODUCT. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON (B)(6) 2023, STATED THAT THE FITTING ISSUES WERE NOT REPORTED. IT WAS REPORTED THAT AFTER SEVERAL USES, IT NO LONGER DISPLAYED THE NORMAL TEMPERATURE. THE CRACK IN THE CONNECTOR ON THE SIDE THAT CONNECTS TO THE TEMPERATURE SENSOR CATHETER WAS INTENTIONALLY CUT BY THE HOSPITAL TECHNICIAN TO CHECK THE STRUCTURE OF THE PRODUCT. THE USER CUT THE CONNECTOR AFTER THE EVENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17037782 ↗MalfunctionJan 28, 2023Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE TEMPERATURE SENSING EXTENSION CORD HAS WRONG TEMPERATURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261591 ↗MalfunctionJan 28, 2023Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT TEMPERATURE SENSING EXTENSION CORD HAD WRONG TEMPERATURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261590 ↗MalfunctionDec 19, 2022Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THERE WAS A TEMPERATURE DISPLAY MALFUNCTION. IT WAS STATED THAT THE TEMPERATURE WAS DISPLAYED ON THE MONITOR, BUT THE TEMPERATURE FLUCTUATED WILDLY WHILE USING THE EXTENSION CORD OF THE TEMPERATURE SENSING CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16007801 ↗MalfunctionDec 16, 2022Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE TEMPERATURE DISPLAY WAS POOR. IT WAS STATED THAT 31 DAYS AFTER USE, THE PATIENT TEMPERATURE DISPLAY WAS DISAPPEARING OR APPEARING LOWER THAN ACTUAL WHILE USING THE EXTENSION CORD OF THE TEMPERATURE SENSING CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15997172 ↗MalfunctionDec 9, 2022Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE TEMPERATURE SENSING EXTENSION CORD HAD POOR TEMPERATURE DISPLAY AND THE TEMPERATURE DISPLAY DISAPPEARED. PER FOLLOW-UP RECEIVED VIA IBC ON 16DEC2022, STATED THAT TEMPERATURE SENSING EXTENSION CORD HAD POOR DISPLAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15950941 ↗MalfunctionJan 29, 2022No Display/Image; Insufficient Device Problem Information; No Display/Image; Insufficient Device Problem Information
IT WAS REPORTED THAT THE TEMPERATURE SENSOR WAS DEFECTIVE ON THE DAY OF USE. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 19JAN2022, TEMPERATURE SENSOR IS ONLY MENTIONED AS DEFECTIVE, AND THE DETAILS ARE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13390004 ↗MalfunctionMar 19, 2020No Display/Image
IT WAS REPORTED THAT WHILE USING THE CORD EXTENSION FOR TEMP SENSE CATHETER, THE BODY TEMPERATURE OF THE PATIENT WAS NOT DISPLAYED ON THE MONITOR. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 26FEB2020, IT WAS UNKNOWN IF THE TEMP SENSING CATHETER OR MONITOR WERE WORKING CORRECTLY AFTER THE CABLE WAS CHANGED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9853385 ↗MalfunctionMar 26, 2019Erratic or Intermittent Display; Temperature Problem; Erratic or Intermittent Display
IT WAS REPORTED THAT THE BODY TEMPERATURE WAS NOT INDICATED CORRECTLY.
Patient problems: Alteration In Body Temperature; No Consequences Or Impact To Patient
MAUDE report 8452689 ↗MalfunctionAug 21, 2017Image Display Error/Artifact
IT WAS REPORTED THAT THE DEVICE DID NOT DISPLAY THE CORRECT BODY TEMPERATURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6808956 ↗MalfunctionAug 16, 2017Temperature Problem
IT WAS REPORTED THAT THE BODY TEMPERATURE INDICATED WAS INCORRECT WHEN THE RELAY CABLE WAS CONNECTED TO THE CATHETER. THERE WAS NO INFORMATION PROVIDED ON THE NUMBER OF TIMES THE RELAY CABLE WAS USED PRIOR TO THIS EVENT.
Patient problems: No Information
MAUDE report 6797329 ↗MalfunctionAug 15, 2017Temperature Problem
IT WAS REPORTED THAT THE INDICATED BODY TEMPERATURE WAS NOT CORRECT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6796217 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page