Acumen IQ Cuff AIQCMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103203332), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 malfunction.

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

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 18, 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.

• MalfunctionApr 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AN AIQ CUFF HAD LOW READINGS COMPARED TO A BP CUFF. READINGS WERE 90S/40S. SALES REP TRIED MOVING THE HRS, BUT SAW NO CHANGES TO THE BP. MODEL AND LOT NUMBER WERE PROVIDED. NO PATIENT INJURY REPORTED. PER FOLLOW-UP, AIQ CUFF AND BP CUFF WAS USED ON DIFFERENT EXTREMITIES. NO ERROR MESSAGES OR ALARM ACCOMPANIED LOW READINGS. CABLES WERE CHECKED, BUT THE READINGS STAYED THE SAME. ISSUE WAS RESOLVED WHEN THE CUFF WAS EXCHANGED TO A LARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166752 ↗