FLOTRAC MHD6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103194586), received between Dec 20, 2023 and Dec 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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-0411-2024 · Oct 4, 2023 · Open, Classified
  FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, 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.
• 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-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.