Acumen IQ AIQS8R5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103201178), received between Jul 24, 2024 and Jul 24, 2024 — classified as 1 malfunction.

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

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

3 other recalls cover devices cleared under the same FDA submission (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.

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-0409-2024 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionJul 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE INACCURATE CARDIAC INDEX VALUES WITH THE PRESSURE MONITORING ACUMEN IQ SENSOR. THIS OCCURRED DURING USE. THE CARDIAC INDEX VALUE THAT WAS DISPLAYED WAS 1.1LMIN M2. THIS WAS A LOWER THAN EXPECTED VALUE OF 2.0LMIN M2. THE DEVICE WAS ABLE TO BE ZEROED. THERE WAS NO ABNORMAL WAVEFORM THAT WAS OBSERVED. THERE WERE NO ERROR MESSAGES THAT DISPLAYED. ANY TROUBLESHOOTING WAS UNABLE TO BE PERFORMED. THE EXACT OCCURRENCE DATE IS NOT KNOWN. THE PATIENT DEMOGRAPHICS WAS REQUESTED BUT UNABLE TO BE PROVIDED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822968 ↗

Recalls under the same FDA submission

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

• 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-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.