FLOTRAC MHD8Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103194609), received between Aug 8, 2024 and Aug 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K131588, K131892, K152980); 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.

Recalls naming this device

1. Oct 4, 2023Open, Classified

   Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

   Z-0411-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, AFTER BEING CORRECTLY CONNECTED, THIS FLOTRAC SENSOR CONSISTENTLY DISPLAYED A SIGNIFICANTLY LOW DIASTOLIC BLOOD PRESSURE OF 10 MMHG, DESPITE THE EXPECTED NORMAL RANGE BEING 60/80 MMHG. NO ERROR MESSAGE WAS DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INCORRECT VALUES. THE ISSUE WAS SOLVED REPLACING THE UNIT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802671 ↗
• MalfunctionJul 2, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, BEFORE OPENING THE PACKAGE OF THIS FLOTRAC SENSOR, THE PACKAGE WAS FOUND BROKEN AND THE STERILITY WAS AFFECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382421 ↗
• MalfunctionJun 4, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE WITH PATIENT, THE BLOOD PRESSURE VALUE OBTAINED WITH THIS FLOTRAC SENSOR WAS TOO HIGH AND INACCURATE. THE EXPECTED VALUE ACCORDING TO PATIENT STATUS WAS AROUND 100 MMHG; HOWEVER, THE VALUE PROVIDED BY THE DEVICE WAS UNABLE TO BE OBTAINED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, SINCE IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138683 ↗
• MalfunctionSep 4, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT, THIS FLOTRAC SENSOR PROVIDED AN INACCURATE OUTPUT. THE ISSUE WAS SOLVED REPLACING THE DEVICE. NO FURTHER INFORMATION AVAILABLE REGARDING THE INACCURATE VALUES OBTAINED. THERE WAS NO ALLEGATION OF PATIENT INJURY, AND PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133797 ↗
• MalfunctionAug 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED WITH THIS FLOTRAC SENSOR, THE END OF THE PRESSURE TUBING, THE STOPCOCK LUER WAS DETACHED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938356 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131588, K131892, K152980. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2024 · Oct 4, 2023 · Open, Classified
  Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
• Z-0412-2024 · Oct 4, 2023 · Open, Classified
  FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.
• Z-0410-2024 · Oct 4, 2023 · Open, Classified
  Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.