FLOTRAC MHD65Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103194593), received between Oct 23, 2023 and Oct 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• 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 ↗

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.
• 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.