FLOTRACRecalls & reported problems across all models

We found 4 models of FLOTRAC by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2023 and Aug 14, 2025 — classified as 7 malfunctions.

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

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

FLOTRAC recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported FLOTRAC problems

FLOTRAC models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FLOTRAC MHD8

  COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
  1 recall5 reports
• FLOTRAC MHD85

  CATHETER, OXIMETER, FIBEROPTIC
  1 recall0 reports
• FLOTRAC MHD6

  CATHETER, OXIMETER, FIBEROPTIC
  1 report
• FLOTRAC MHD65

  COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
  1 report

Recent FLOTRAC adverse event reports

The 7 most recent reports across all models, 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 ↗
• MalfunctionDec 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE INACCURATE ARTERIAL BLOOD PRESSURE VALUES WITH THE PRESSURE MONITORING FLOTRAC SENSOR. THIS OCCURRED DURING PATIENT MONITORING. THE BLOOD PRESSURE VALUES ON THE PATIENT BEDSIDE MONITOR WERE 5 TO 10MMHG HIGHER THAN WHAT WAS BEING DISPLAYED ON THE HEMOSPHERE MONITOR. THERE WERE NO ERROR MESSAGES THAT DISPLAYED. THERE WAS NO ABNORMAL WAVEFORM THAT DISPLAYED. THERE WAS NO TROUBLESHOOTING OR REPLACEMENT OF THE DEVICE THAT WAS PERFORMED. THE PRESSURE MONITORING DEVICE WAS ABLE TO BE ZEROED BEFORE USE. THERE WAS NO OCCLUSION, LEAKAGE OR KINK THAT OCCURRED. THE INFORMATION REGARDING THE EXPECTED VALUES AND WHETHER THE VALUES AND THE WAVEFORM MATCHED ARE NOT KNOWN. THE PATIENT DEMOGRAPHICS WERE REQUESTED BUT ARE UNAVAILABLE. THERE WAS NO INAPPROPRIATE TREATMENT ADMINISTERED TO THE PATIENT. THE OTHER EDWARDS COMPONENTS USED IN THE MONITORING WERE RULED OUT AS SUSPECT. THERE IS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366650 ↗
• MalfunctionOct 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE A NURSE WAS REPOSITIONING A PATIENT IT WAS NOTICED THAT THE FLOTRAC ARTERIAL TUBING CAME APART AT THE CONNECTION BELOW THE TRANSDUCER. NO HARM TO PATIENT. IT WAS CAUGHT IMMEDIATELY. IT WAS REPORTED THAT THE DEFECTIVE SAMPLE WAS DISCARDED BY CLINICIAN. PER THE CUSTOMER, THE CONNECTION THAT CAME APART WAS A NON BONDED CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985734 ↗

Other Edwards Lifesciences LLC products

• Edwards SAPIEN 315 models · 6,905 reports · 1 recall
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
• INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
• EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
• SAPIEN 3 Ultra RESILIA4 models · 881 reports
• SAPIEN 3 Ultra System3 models · 876 reports
• FOGARTY32 models · 486 reports · 3 recalls