FLOTRAC, VAMP MHD6AZRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103194722), received between Mar 19, 2019 and Oct 19, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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-0412-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A FLOTRAC DEVICE HAD INACCURATE BLOOD PRESSURE VALUES. FLOTRAC WAS ATTACHED TO A HEMOSPHERE AND NON EDWARDS BEDSIDE MONITOR, GE HEALTHCARE. CLINICIAN NOTED THAT THE FLOTRAC DISPLAYED UNEXPECTED SPIKES IN THE BLOOD PRESSURE READINGS. EXCHANGING THE DEVICE RESOLVED THE ISSUE. NO PATIENT INJURIES. USED DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17970721 ↗
• MalfunctionOct 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A FLOTRAC DEVICE HAD INACCURATE BLOOD PRESSURE VALUES. FLOTRAC WAS ATTACHED TO A HEMOSPHERE AND NON EDWARDS BEDSIDE MONITOR, GE HEALTHCARE. CLINICIAN NOTED THAT THE FLOTRAC DISPLAYED UNEXPECTED SPIKES IN THE BLOOD PRESSURE READINGS. EXCHANGING THE DEVICE RESOLVED THE ISSUE. NO PATIENT INJURIES. USED DEVICE WAS DISCARDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17970695 ↗
• MalfunctionOct 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A FLOTRAC DEVICE HAD INACCURATE BLOOD PRESSURE VALUES. FLOTRAC WAS ATTACHED TO A HEMOSPHERE AND NON EDWARDS BEDSIDE MONITOR, GE HEALTHCARE. CLINICIAN NOTED THAT THE FLOTRAC DISPLAYED UNEXPECTED SPIKES IN THE BLOOD PRESSURE READINGS. EXCHANGING THE DEVICE RESOLVED THE ISSUE. NO PATIENT INJURIES. USED DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17970672 ↗
• MalfunctionMar 19, 2019Material Fragmentation; Loose or Intermittent Connection

  THE END OF DEVICE WHERE THE STOPCOCK IS LOCATED WAS "WOBBLY". NURSE UNSCREWED IT FROM THE WHITE RECTANGULAR PORTION AND BITS OF PLASTIC FELL OUT.

  Patient problems: No Information

  MAUDE report 8431573 ↗

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-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.