Acumen IQ AIQS6C502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103201000), received between Jan 17, 2025 and Jan 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

4 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.

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.

• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT DURING USE THE ACUMEN BROKE AT THE CENTRAL LINE TUBING. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183695 ↗

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-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.
• 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.