Acumen IQRecalls & reported problems across all models

We found 9 models of Acumen IQ by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2023 and Mar 25, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Acumen IQ recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 7 of these models · Recall details · FDA record ↗

Most reported Acumen IQ problems

Acumen IQ models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Acumen IQ AIQS85

  Transducer, Blood-Pressure, Extravascular
  1 recall7 reports
• Acumen IQ AIQS8

  Transducer, Blood-Pressure, Extravascular
  1 recall1 report
• Acumen IQ AIQS8R5

  Transducer, Blood-Pressure, Extravascular
  1 recall1 report
• Acumen IQ AIQS65

  Transducer, Blood-Pressure, Extravascular
  1 recall0 reports
• Acumen IQ AIQS6R5

  Transducer, Blood-Pressure, Extravascular
  1 recall0 reports
• Acumen IQ AIQS6

  Transducer, Blood-Pressure, Extravascular
  1 recall0 reports
• Acumen IQ AIQS6R

  Transducer, Blood-Pressure, Extravascular
  1 recall0 reports
• ACUMEN IQ AIQFM10

  Computer, Diagnostic, Programmable
  3 reports
• Acumen IQ AIQS6C502

  Transducer, Blood-Pressure, Extravascular
  1 report

Recent Acumen IQ adverse event reports

The 13 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Infusion or Flow Problem

  AS REPORTED, DURING USE IN PATIENT, WITH THIS HEMOSPHERE FLUID METER CONNECTED TO A HEMOSPHERE MONITOR, THE VOLUME OF FLUID WAS NOT TRACKED (SEE VIDEO ATTACHED). IT WAS DISCONNECTED AND CONNECTED SEVERAL TIMES BUT THE ISSUE REMAINED. IT WAS SOLVED REPLACING THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684767 ↗
• MalfunctionDec 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED, DURING USE THIS ACUMEN FLUID METER DID NOT INITIALIZE AND DISPLAYED BOLUS VOLUME ADMINISTERED AND THE ERROR MESSAGE "FLOW RATE DETECTED TOO HIGH", EVEN THOUGHT THE LINE WAS CLOSED AND NO BOLUS HAD BEEN INJECTED INTO THE PATIENT SINCE AS PER USER BEST PRACTICES THE LINE IS NOT OPENED UNTIL THE SYSTEM INDICATES THAT A BOLUS CAN BE INJECTED. CABLE WAS DISCONNECTED AND RECONNECTED SEVERAL TIMES AND ALSO REPLACED WITH A NEW ONE WITHOUT SUCCESS. THE ISSUE WAS SOLVED WHEN THE FLUID METER WAS CHANGED. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726162 ↗
• MalfunctionJun 9, 2025Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED, WHEN PERFORMING THE BOLUS WITH THIS FLUID METER, THE FLUID WAS INFUSED CORRECTLY BUT IT WAS NOT TRACKED. LATER, IT DETECTED THE PASSAGE OF FLUID WHEN EVERY LINE WAS CLOSED AND NOTHING WAS BEING INJECTED. THERE WAS NO INCORRECT FLUID ADMINISTRATION TO THE PATIENT; THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165407 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE INACCURATE CARDIAC INDEX VALUES WITH THE PRESSURE MONITORING ACUMEN IQ SENSOR. THIS OCCURRED DURING USE. THE CARDIAC INDEX VALUE THAT WAS DISPLAYED WAS 1.1LMIN M2. THIS WAS A LOWER THAN EXPECTED VALUE OF 2.0LMIN M2. THE DEVICE WAS ABLE TO BE ZEROED. THERE WAS NO ABNORMAL WAVEFORM THAT WAS OBSERVED. THERE WERE NO ERROR MESSAGES THAT DISPLAYED. ANY TROUBLESHOOTING WAS UNABLE TO BE PERFORMED. THE EXACT OCCURRENCE DATE IS NOT KNOWN. THE PATIENT DEMOGRAPHICS WAS REQUESTED BUT UNABLE TO BE PROVIDED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822968 ↗
• 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 ↗

Other Edwards Lifesciences LLC products

• Edwards SAPIEN 315 models · 6,905 reports · 1 recall
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
• INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
• EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
• SAPIEN 3 Ultra RESILIA4 models · 881 reports
• SAPIEN 3 Ultra System3 models · 876 reports
• FOGARTY32 models · 486 reports · 3 recalls