Acumen IQ Cuff Adult AIQCARecalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00690103219067), received between Mar 21, 2024 and Jul 18, 2025 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (50 reports).

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 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER USE OF THE ACUMEN IQ FINGER CUFF, POSITIONED ADJACENT TO A FINGER WITH A PULSE OXIMETRY SENSOR, THE PATIENT DEVELOPED A BLISTER ON THEIR FINGER. NO STEPS WERE TAKEN INTRA-OPERATIVELY TO TREAT THE BLISTER. THERE WAS NO OTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22547569 ↗
• MalfunctionJul 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER USE OF THE ACUMEN IQ FINGER CUFF, POSITIONED ADJACENT TO A FINGER WITH A PULSE OXIMETRY SENSOR, THE PATIENT DEVELOPED A BLISTER ON THEIR FINGER. NO STEPS WERE TAKEN INTRA-OPERATIVELY TO TREAT THE BLISTER. THERE WAS NO OTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22547140 ↗
• MalfunctionJul 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER USE OF THE ACUMEN IQ FINGER CUFF, POSITIONED ADJACENT TO A FINGER WITH A PULSE OXIMETRY SENSOR, THE PATIENT DEVELOPED A BLISTER ON THEIR FINGER TIP. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED. THERE WAS NO OTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22487280 ↗
• MalfunctionJul 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER USE OF THE ACUMEN IQ FINGER CUFF, POSITIONED ADJACENT TO A FINGER WITH A PULSE OXIMETRY SENSOR, THE PATIENT DEVELOPED A BLISTER ON THEIR FINGER TIP. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED. THERE WAS NO OTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22487275 ↗
• MalfunctionJun 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, AN ACUMEN ADULT CUFF HAD FITTING ISSUES WHICH CAUSED INACCURATE MEAN ARTERIAL PRESSURE (MAP) MEASUREMENTS. CUFF WAS APPLIED ON THE LEFT RING FINGER AND CONNECTED TO CUFF #1, BUT THEY COULD NOT GET A GOOD SIGNAL. FINGER CUFF WAS MEASURING A MAP OF 15 TO 20 POINTS LOWER THAN THE BRACHIAL NON-INVASIVE BLOOD PRESSURE (NIBP) ON BOTH ARMS. THERE WERE NO ERROR MESSAGES DISPLAYED. STAFF TRIED TO REPOSITION AND TIGHTEN FINGER CUFF BUT ISSUE COULD NOT BE RESOLVED. THE CUFF CAN ONLY FIT THE PATIENT'S LEFT AND RIGHT RING FINGERS DUE TO THE OTHER FINGERS BEING TOO LARGE. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290340 ↗
• MalfunctionJun 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, AN ACUMEN ADULT CUFF HAD MAP READINGS THAT WERE ABOUT 25MMHG TO 40MMHG COMPARED TO A NIBP ARM CUFF. FINGER CUFF WAS PLACED ON THE OPPOSITE ARM OF THE NIBP CUFF. NO ERROR MESSAGES WERE DISPLAYED ON THE MONITOR. ALL POSSIBLE TROUBLESHOOTING WAS DONE BUT ISSUE CONTINUED. CUFF WAS ATTACHED TO A HEMISPHERE WITH 3.2 PLATFORM. THERE WAS NO PATIENT HARM. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288323 ↗
• MalfunctionJun 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, AN ACUMEN ADULT CUFF HAD MEAN ARTERIAL PRESSURE (MAP) READINGS THAT WERE ABOUT 25MMHG TO 40MMHG LOWER COMPARED TO A NON-INVASIVE BLOOD PRESSURE (NIBP) ARM CUFF. FINGER CUFF WAS PLACED ON THE OPPOSITE ARM OF THE NIBP CUFF. NO ERROR MESSAGES WERE DISPLAYED ON THE MONITOR. ALL POSSIBLE TROUBLESHOOTING WAS DONE BUT ISSUE CONTINUED. CUFF WAS ATTACHED TO A HEMOSPHERE WITH 3.2 PLATFORM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288164 ↗
• MalfunctionJun 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, AN ACUMEN ADULT CUFF HAD MEAN ARTERIAL PRESSURE (MAP) READINGS THAT WERE ABOUT 25MMHG TO 40MMHG LOWER COMPARED TO A NON-INVASIVE BLOOD PRESSURE (NIBP) ARM CUFF. FINGER CUFF WAS PLACED ON THE OPPOSITE ARM OF THE NIBP CUFF. NO ERROR MESSAGES WERE DISPLAYED ON THE MONITOR. ALL POSSIBLE TROUBLESHOOTING WAS DONE BUT ISSUE CONTINUED. CUFF WAS ATTACHED TO A HEMOSPHERE WITH 3.2 PLATFORM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288111 ↗
• MalfunctionMay 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116249 ↗
• MalfunctionMay 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116181 ↗
• MalfunctionMay 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115667 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102457 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102455 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, MULTIPLE AIQCA CUFFS WERE DISPLAYING A MAP OF AT LEAST 22 MM HG BELOW THE READING FROM A NIBP ARM CUFF, SOME WERE MORE THAN 30 MM HG BELOW. THERE WAS NO PATIENT INJURY. NO PATIENT WAS TREATED OFF OF THE INACCURATE VALUES. DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102452 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102446 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102424 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102394 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102363 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098559 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097920 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097868 ↗
• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097701 ↗
• MalfunctionMay 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, MULTIPLE AIQCA CUFFS WERE DISPLAYING A MAP OF AT LEAST 22 MM HG BELOW THE READING FROM A NIBP ARM CUFF, SOME WERE MORE THAN 30 MM HG BELOW. THERE WAS NO PATIENT INJURY. NO PATIENT WAS TREATED OFF OF THE INACCURATE VALUES. DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092770 ↗
• MalfunctionMay 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20-30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092679 ↗
• MalfunctionMay 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ACUMEN CUFF IT DISPLAYED A MAP VALUE APPROXIMATELY 20 TO 30 MM HG LOWER THAN EXPECTED WHEN COMPARED TO THE NIBP. TROUBLESHOOTING DID NOT RESOLVE THIS ISSUE. THERE WAS NO TREATMENT PROVIDED BASED ON INACCURATE VALUES AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092441 ↗