CDI™ Shunt Sensor CDI510HRecalls & reported problems

Summary

The FDA's MAUDE database contains 184 adverse event reports that list this exact device (DI 00699753160767), received between Oct 1, 2014 and Apr 27, 2026 — classified as 4 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (171 reports).

4 other recalls cover devices cleared under the same FDA submission (K133658); they may or may not involve this specific model.

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 184 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS, BLOOD LEAKAGE WAS OBSERVED WHILE CLEANING UP, WHEN THE SHUNT SENSOR WAS REMOVED FROM THE BPM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002058 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS; AFTER INITIATING EXTRACORPOREAL CIRCULATION, BLOOD LEAKAGE WAS DETECTED FROM THE SHUNT SENSOR. THE SHUNT SENSOR LINE WAS CLAMPED OFF WITH FORCEPS, AND THE PROCEDURE WAS CONTINUED WITHOUT MEASURING WITH THE SHUNT SENSOR. NO HEALTH CONSEQUENCE OR IMPACT TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS AN UNKNOWN AMOUNT OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716330 ↗
• MalfunctionMar 30, 2026Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, WHEN THE PUMP STARTED, LEAKAGE OF PRIMING SOLUTION WAS NOTED FROM THE SENSOR LOCATED ON THE SIDE WITH THE BLUE LUER CAP. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT *PRODUCT WAS CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716303 ↗
• MalfunctionJan 7, 2026Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, LEAKAGE FROM THE SHUNT SENSOR WAS NOTICED. NO PATIENT INVOLVEMENT PRODUCT WAS CHANGED OUT PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23994457 ↗
• MalfunctionDec 19, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, WHEN ATTACHING THE SHUNT SENSOR TO THE BLOOD PARAMETER MONITOR (BPM), LEAKAGE OF BUFFER SOLUTION WAS OBSERVED. NO PATENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850443 ↗
• MalfunctionDec 19, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, LEAKAGE OF BUFFER SOLUTION FROM THE VENT LURE ADAPTER WAS OBSERVED. *NO PATIENT INVOLVEMENT. *PRODUCT WAS CHANGED OUT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850379 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, WHEN POSITIVE PRESSURE WAS APPLIED, BLOOD LEAKED FROM THE BLUE LUER CAP. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT, PRODUCT WAS CHANGED OUT, THE BLOOD LOSS AMOUNT IS UNKNOWN, PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575911 ↗
• MalfunctionNov 14, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS, IT WAS NOTICED THAT BLOOD HAD ATTACHED TO THE BPM CABLE-HEAD. LEAKAGE FROM THE SHUNT SENSOR DURING CIRCULATION WAS SUSPECTED. THERE WAS NO DISCREPANCIES BETWEEN THE VALUES MEASURED BY THE CDI SYSTEM AND THE LABORATORY-MEASURED VALUES. NO ERRORS WERE REPORTED DURING GAS CALIBRATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23558333 ↗
• MalfunctionNov 14, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THERE WAS LEAKAGE OCCURRED AT THE LARGE BLUE LUER CAP. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23557397 ↗
• MalfunctionOct 24, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED BLOOD LEAKAGE ON THE SMALL BLUE LUER SIDE. *NO HEALTH CONSEQUENCES OR IMPACT. *PRODUCT WAS CHANGED OUT. *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384298 ↗
• InjurySep 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A CROSS-THREAD IN THE SHUNT FROM THE PACKAGING. AS PER THE SUBSIDIARY, THERE WAS A CROSS-THREAD IN THE SHUNT FROM THE PACKAGING, WHICH CAUSED BLOOD TO LEAK OUT IN THE FIELD. THE CLINICIAN ALSO CONFIRMED THAT IT WAS A MIS-THREAD AND THAT NO OTHER BLOOD WAS GIVEN TO THE PATIENT. THE PATIENT WAS AN INFANT WITH BLOOD LOSS BETWEEN 5ML AND 8ML. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. *PRODUCT WAS NOT CHANGED OUT; IT WAS JUST RETIGHTENED TO ENSURE THE THREAD WAS CORRECT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998868 ↗
• MalfunctionJun 19, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, LEAKAGE WAS OBSERVED FROM THE BLUE CAP DURING PRIMING. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289808 ↗
• MalfunctionMay 16, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THEY NOTICED A LEAKAGE FROM THE SHUNT SENSOR. AS PER THE SUBSIDIARY, DURING GAS CALIBRATION, LEAKAGE OCCURRED (PROBABLY FROM THE LARGE BLUE LUER CAP). THE SHUNT SENSOR WAS THEREFORE CHANGED OUT. *NO PATIENT INVOLVEMENT. *PRODUCT WAS CHANGED OUT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035120 ↗
• MalfunctionMay 9, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A LEAKAGE DURING PRIMING OF THE SHUNT SENSOR WAS OBSERVED. THE SHUNT SENSOR WAS CONNECTED TO THE TUBE TO START PRIMING. AFTER PRIMING WAS COMPLETED, LEAKAGE WAS OBSERVED WHEN THE PUMP WAS STOPPED. THE MEDICAL ENGINEER REPORTED THAT THE LEAKAGE MAY HAVE OCCURRED ON THE SMALL BLUE LUER SIDE AT THE BOTTOM OF THE SHUNT SENSOR. NO PATIENT INVOLVEMENT, PRODUCT WAS CHANGED OUT, PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997421 ↗
• MalfunctionApr 4, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THEY NOTICED LEAK FROM THE SHUNT SENSOR. IT IS UNKNOWN IF THERE WAS A DELAY AND IF THE SURGERY WAS COMPLETED SUCCESSFULLY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773100 ↗
• MalfunctionApr 4, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, DURING OUT OF BOX, WHEN THE SHUNT SENSOR WAS UNPACKED, LEAKAGE OF BUFFER SOLUTION WAS FOUND. *NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772684 ↗
• MalfunctionJan 31, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING SET-UP THERE WAS A LEAKAGE FROM THE PLASTIC CONNECTOR. AS PER THE SUBSIDIARY, IT LOOKS AS THE CONNECTION IS NOT SECURED WELL WHEN LINE IS LOCKED. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282774 ↗
• MalfunctionJan 3, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME THERE WAS A SHUNT SENSOR HAS LEAKAGE. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT *PRODUCT WAS CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071024 ↗
• MalfunctionDec 13, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A LEAKAGE WAS OBSERVED. AS PER THE SUBSIDIARY, FOUR ARTERIAL SENSORS WITH LEAKAGE WAS OBSERVED AND ONLY ONE OF THESE FOUR HAS BEEN SAVED. THE LEAKAGE IS IN THE LUER CONNECTION AT THE SENSOR'S INLET. *NO PATIENT INVOLVEMENT *PRODUCT WAS CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929458 ↗
• MalfunctionDec 6, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING SET-UP THERE WAS LEAKAGE FROM THE SHUNT SENSOR. AS PER THE SUBSIDIARY, WHEN THE SHUNT SENSOR WAS UNPACKED, LEAKAGE OF BUFFER SOLUTION WAS FOUND AND THE INSIDE OF THE PACKAGE WAS QUITE WET. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867318 ↗
• MalfunctionOct 11, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THERE WAS A SHUNT SENSOR LEAKAGE. AS PER THE SUBSIDIARY DURING PRIMING, FLUID LEAKED FROM THE SMALL BLUE LUER ON THE SHUNT SENSOR. WHEN THE BLOOD TUBING CONNECTORS WERE ATTACHED WITHOUT THE SHUNT SENSOR, NO LEAKAGE OCCURRED. AFTER CONFIRMING THE LEAKAGE, EXTRACORPOREAL CIRCULATION PROCEEDED WITHOUT THE SHUNT SENSOR. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433233 ↗
• MalfunctionOct 3, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THERE WAS A LEAKAGE. AS PER THE SUBSIDIARY, DURING PRIMING BEFORE USING IT TO THE PATIENT, LEAKAGE OCCURRED. THE SHUNT SENSOR WAS THEREFORE NOT USED AND WAS REPLACED WITH ANOTHER SHUNT SENSOR TO CONTINUE THE PROCEDURE. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363680 ↗
• MalfunctionSep 13, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THEY NOTICED A LEAKING CDI SHUNT SENSOR. IT WAS TRIED SEVERAL TIMES TO DISCONNECT AND RECONNECT, BUT IT PERSISTED LEAKING. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217893 ↗
• MalfunctionSep 12, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THEY NOTICED A LEAKAGE. AS PER THE SUBSIDIARY, DURING PRIMING AFTER GAS CALIBRATION, LEAKAGE WAS OBSERVED FROM THE CONNECTING PORTION ON THE SMALL BLUE LUER SIDE. THE SHUNT SENSOR WAS THEREFORE NOT USED AND WAS REPLACED WITH ANOTHER SHUNT SENSOR, WHICH WAS USED WITHOUT PROBLEMS. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207054 ↗
• MalfunctionAug 20, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THERE WAS A LEAKAGE FROM THE SHUNT SENSOR AT THE PART CONNECTED TO THE CIRCUIT. AS PER THE USER FACILITY, THE SENSOR WAS DETACHED AND REATTACHED TO THE CIRCUIT, BUT LEAKAGE WAS UNABLE TO BE STOPPED. THE SHUNT SENSOR WAS NOT USED AND A BACKUP SHUNT SENSOR WAS USED WITHOUT LEAKAGE. *NO PATIENT INVOLVEMENT , *PRODUCT WAS CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007066 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133658. One submission often covers many models, so check the product and lot details in each record.

• Z-2751-2018 · Jun 26, 2018 · Terminated
  Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provide
• Z-2750-2018 · Jun 26, 2018 · Terminated
  CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure o
• Z-1250-2016 · Mar 14, 2016 · Terminated
  CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extrac
• Z-2742-2015 · Aug 7, 2015 · Terminated
  CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen sa