Acumen IQ AIQS85Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00690103200942), received between Nov 30, 2023 and Jan 10, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN ACUMEN AIQS85 WAS DISPLAYING INACCURATE VALUES AS COMPARED TO THE SWAN-GANZ CATHETER PLACED ON POST-OP DAY - POD 4. DURING THE OR PROCEDURE, THE PATIENT HAD INSTABILITY AND WAS UNREACTIVE TO ANTI-HYPOTENSIVE MEDS PER THE ACUMEN IQ READINGS. THROUGHOUT THE COURSE OF 3 DAYS POST-OP, THE PATIENT PARAMETERS CONTINUED TO INDICATE VASOPLEGIC SHOCK AND WAS TREATED WITH MULTIPLE TYPES OF ANTI-HYPOTENSIVE MEDS. AN ECHO SHOWED THAT THE EJECTION FRACTION HAD GONE FROM 40 PERCENT IN THE OR TO 28 PERCENT. POD 4, THE PATIENT WAS REINTUBATED AND A SWAN-GANZ CATHETER WAS PLACED THROUGH THE INTRODUCER. PER THE SWAN-GANZ CATHETER AND VERIFIED BY FICK CALCULATION, THE PARAMETERS INDICATED THE PATIENT WAS IN CARDIOGENIC SHOCK. THE MOST RECENT UPDATE REPORTED THAT THE PATIENT IS IN THE ICU WITH A BALLOON PUMP. TROUBLESHOOTING WAS NOT DONE AS NO PROBLEM WAS RECOGNIZED UNTIL THE SWAN-GANZ CATHETER WAS PLACED. WHEN THE SWAN WAS PLACED, THE ACUMEN WAS NO LONGER UTILIZED. THE PATENT REQUIRED CARDIAC CATHETERIZATION, REINTUBATION, AND EXTUBATION. THE SURGEON STATED IN CONVERSATION WITH THE SALES REPRESENTATIVE THAT ONCE THE PATIENT STARTED TO DECOMPENSATE AFTER POD 1, A SWAN-GANZ SHOU

  Patient problems: Shock

  MAUDE report 18485476 ↗
• MalfunctionDec 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF AN ACUMEN IQ SYSTEM A 56-YEAR-OLD FEMALE WITH AN EJECTION FRACTION OF 60-65% AND TWO VESSEL DISEASE. THE PATIENTS STROKE VOLUME DISPLAYED A HIGH NUMBER ON THE MONITOR THAT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. TROUBLE SHOOTING WAS ATTEMPTED TO RESOLVE THE ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387578 ↗
• MalfunctionDec 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN FIRST ATTACHED THE PATIENT HAD A SV OF 90-100. WITHIN 2 MINUTES THE SV INCREASED TO 150. THE REP TROUBLESHOOTED THE DEVICE AND THE SV DECREASED BACK DOWN TO SV OF 100. PT BP DID NOT CHANGE. PT DOES HAVE A WIDENED PULSE PRESSURE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE WAVEFORM DOES HAVE A HIGH SYSTOLIC PEAK AND A SMALL EXTRA NOTCH. MONITOR SN (B)(6). LOT NUMBER 65259121. EVENT OCCURRED ON 12/01. THERE WAS NO PATIENT INJURY. DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365495 ↗
• MalfunctionDec 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Information; Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Information

  IT WAS REPORTED THAT WHEN THE REP WAS CONNECTING TO A 58 YEAR OLD PATIENT THE SV WAS READING 110. LATER IN THE CASE THE CO INCREASED TO 10 AND CI TO 5. THE PATIENTS CARDIAC INDEX/CARDIAC OUTPUT DISPLAYED A HIGH NUMBER ON THE MONITOR THAT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. TROUBLESHOOTING WAS ATTEMPTED TO RESOLVE THE ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311696 ↗
• MalfunctionDec 12, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT WHEN THE REP WAS CONNECTING TO A 58 YEAR OLD PATIENT THE SV WAS READING 110. LATER IN THE CASE THE CO INCREASED TO 10 AND CI TO 5. THE PATIENTS CARDIAC INDEX/CARDIAC OUTPUT DISPLAYED A HIGH NUMBER ON THE MONITOR THAT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. TROUBLESHOOTING WAS ATTEMPTED TO RESOLVE THE ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311450 ↗
• MalfunctionNov 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Information; Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Information

  IT WAS REPORTED THAT DURING USE OF AN ACUMEN IQ SENSOR WITH A 48M PATIENT HAD AN INITIAL STROKE VOLUME OF 112 AND CARDIAC OUTPUT OVER 10. THE PATIENT HAD AN ACUTE MI AND THE CARDIAC OUTPUT/STROKE VOLUME DISPLAYED A HIGH NUMBER ON THE MONITOR THAT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. TROUBLESHOOTING WAS ATTEMPTED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243475 ↗
• MalfunctionNov 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF AN ACUMEN IQ SENSOR WITH A 72 YEAR OLD PT HAD AN INITIAL SVI OF 61 AND CI OF 4.1. THE PATIENTS CARDIAC INDEX/STROKE VOLUME INDEX DISPLAYED A HIGH NUMBER ON THE MONITOR THAT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. TROUBLESHOOTING WAS ATTEMPTED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242449 ↗

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-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.