Acumen IQ AIQS8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103201086), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (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. 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-0409-2024 · Root cause: Device Design · 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.

• MalfunctionAug 22, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT, THIS ACUMEN IQ SENSOR WAS WORKING AS EXPECTED PROVIDING CORRECT VITAL PARAMETERS. HOWEVER, AFTER A FEW HOURS, THE SENSOR STARTED PROVIDING INACCURATE PARAMETERS THAT WERE NOT COMPATIBLE WITH LIFE AND DIFFERENT FROM OTHER REFERENCES THAT WERE IN THE OPERATING ROOM (OR). THE DEVICE WAS REPLACED WITH A NEW UNIT AND ISSUE WAS SOLVED. THERE IS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026096 ↗

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-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.