MAQUET CARDIOHELP CARDIOHELP SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 04037691658384), received between Oct 16, 2023 and Sep 30, 2026 — classified as 18 deaths, 6 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (31 reports).

4 FDA recall records name this device's identifier, 4 still open.

5 other recalls cover devices cleared under the same FDA submission (K133598); 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. Apr 15, 2024Open, Classified

   The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.

   Z-1831-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Nov 14, 2023Open, Classified

   CARDIOHELP-i System was not properly tested to measure leakage current

   Z-0595-2024 · Root cause: Process design · FDA record ↗

3. Nov 13, 2023Open, Classified

   Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.

   Z-0605-2024 · Root cause: Component design/selection · FDA record ↗

4. Nov 6, 2023Open, Classified

   Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp

   Z-0555-2024 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  The event occurred in USA during service. It was reported that the venous bubble sensor is defective error message was displayed. No harm to any person has been reported. As a bubble sensor defective alarm could lead to a zero flow mode, a report is required. Complaint ID (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946109 ↗
• MalfunctionSep 29, 2026Pressure Problem

  The event occurred in Hong Kong during priming. It was reported that Part and Pven could not be zeroed during priming. The issue was confirmed on-site, and rust / corrosion was observed on the connection cable pin. The connection cable for the disposable was replaced. No harm to any person has been reported. A pressure reading issue, can lead to a pump stop, if the intervention is set by the user, therefore a report is required. Complaint#: (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930814 ↗
• DeathSep 28, 2026Detachment of Device or Device Component

  The event occurred in China during treatment. It was reported that the Cardiohelp package detached during transport of the patient, causing a backflow for 6 minutes. The patient passed. As the patient passed, a report is required. Complaint ID (b)(4).

  Patient problems: Insufficient Information

  MAUDE report 50916653 ↗
• DeathSep 28, 2026Detachment of Device or Device Component

  The event occurred in China during treatment. It was reported that the Cardiohelp package detached during transport of the patient, causing a backflow for 6 minutes. The patient passed. As the patient passed, a report is required. Complaint ID (b)(4).

  Patient problems: Insufficient Information

  MAUDE report 50915513 ↗
• MalfunctionSep 28, 2026Mechanical Problem

  The event occurred in the USA during incoming inspection with no patient involvement. It was reported that the Flow/Bubble Sensor that came in with the unit is physically damaged "cracked". No harm to any person has been reported. As a Flow Bubble Sensor issue, can lead to a pump stop, if the intervention is set by the user, a report is required. Complaint ID (b)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910932 ↗
• MalfunctionSep 24, 2026Pressure Problem

  The event occurred in USA. It was reported that the arterial pressure is not zeroing and fluctuating. No harm to any person has been reported. As a pressure reading issue, can lead to a pump stop if the intervention is set by the user, a report is required. Complaint ID (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877944 ↗
• MalfunctionSep 21, 2026Defective Alarm

  The event occurred in Italy. It was reported that bubble sensor will be replaced, no further information provided yet. No harm to any person has been reported. As a bubble sensor defective alarm could lead to a zero flow mode, a report is required. Complaint (b)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835384 ↗
• MalfunctionSep 14, 2026Overheating of Device

  The event was occurred in France during installation. It was reported that the Cardio help displayed the error message "Case 2 fan defective." On (b)(6) 2026, on the provided logfiles of the Cardio help device it was found that drive fan 2, housing fan 1 and housing fan 2 defective. No harm to any person has been reported. As both fans of the same type are affected, improper cooling of the product can occurred, therefore a report is required. Complaint #(b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750812 ↗
• MalfunctionAug 18, 2026No Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298054 ↗
• MalfunctionAug 12, 2026Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218389 ↗
• MalfunctionAug 11, 2026Infusion or Flow Problem; Incomplete or Inadequate Priming

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205543 ↗
• DeathApr 16, 2026No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED, THAT THE SCREEN WENT BLACK, CAUSING BLOOD FLOW VALUES TO BE UNREADABLE. THE FAILURE OCCURRED DURING TREATMENT. THE CARDIOHELP WAS NOT REPLACED BECAUSE IT RETURNED TO NORMAL ON ITS OWN AFTER A WHILE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID :(B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON 2026-04-14: THAT THE PATIENT PASSED AWAY ON (B)(6) 2026. FURTHER IT WAS CONFIRMED THAT THE DEATH WAS NOT CAUSED BY THE EQUIPMENT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24896583 ↗
• MalfunctionMar 30, 2026Pressure Problem

  THE EVENT OCCURRED IN GERMANY PRIOR TO USE. IT WAS REPORTED, THAT PVEN, PART DOES NOT ZERO. NO HARM TO ANY PERSON HAS BEEN REPORTED.AS A PRESSURE FAILURE WAS REPORTED, A REPORT IS NEEDED. COMPLAINT ID:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710717 ↗
• MalfunctionMar 25, 2026Corroded; Device Sensing Problem; Pressure Problem

  THE EVENT OCCURRED IN CHINA DURING TREATMENT. IT WAS REPORTED THAT AN ERROR WAS FOUND IN THE MONITORING OF ARTERIAL PRESSURE VALUES. UPON INSPECTION THE GETINGE FIELD SERVICE TECHNICIAN FOUND THAT THE HLS CABLE NEEDED TO BE REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE, CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685542 ↗
• MalfunctionMar 17, 2026Device Sensing Problem; Pressure Problem

  THE EVENT OCCURRED IN USA BEFORE USE. IT WAS REPORTED THAT THERE WERE PRESSURE READING ISSUES. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE, CAN LEAD TO A PUMP STOP IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615806 ↗
• DeathMar 5, 2026Pressure Problem

  THE EVENT OCCURRED IN FINLAND DURING TREATMENT. IT WAS REPORTED THAT A HLS SET CONNECTED TO A CARDIOHELP WAS PRIMED ACCORDING TO THE INSTRUCTIONS AND THE DEVICE WORKED NORMALLY AFTER CONNECTED TO THE PATIENT WHILE IN ANGIOGRAPHY. HOWEVER, ON A LATER POINT, WITHOUT ANY OBVIOUS CHANGE IN TREATMENT, THE VENOUS PRESSURE (PVEN) STOPPED APPEARING ON THE CARDIOHELP AND AN ALARM WAS DISPLAYED ¿VENOUS PRESSURE OUTSIDE OF THE ALARM LIMITS¿. THE TREATMENT WAS CONTINUED, THE FLOW REMAINED CONSTANT AND THE ARTERIAL, INTERNAL AND DELTA PRESSURE REMAINED CONSTANT. AN ATTEMPT WAS MADE BY THE CUSTOMER TO FIX THE PROBLEM BY REMOVING THE HLS CABLE FROM THE HLS MODULE AND CHECKING THE PINS AND IT WAS CONFIRMED THAT THERE WAS NO DIRT AND THE PINS WERE IN PLACE AND INTACT. ACCORDING TO THE CUSTOMER THE PVEN APPEARED FROM TIME TO TIME AND PRESSURE VALUES FROM +500 TILL +900 WERE DISPLAYED. ADDITIONALLY, THE PVEN ALSO SHOWED NEGATIVE VALUES. THE CUSTOMER CHANGED THE REVOLUTIONS, BUT THIS DID NOT AFFECT THE VENOUS PRESSURE. THE CUSTOMER MONITORED THE FLOW AND THE SUCTION EFFECT OF THE HOSES. IN ADDITION, TOWARDS THE END OF THE TREATMENT THE CARDIOHELP DISPLAYED THE ALARM ¿PVEN DISCONNECTED¿ A FEW TIMES. TH

  Patient problems: Brain Injury

  MAUDE report 24519535 ↗
• MalfunctionMar 5, 2026Pumping Stopped

  THE EVENT OCCURRED IN FRANCE DURING TRANSFER OF A PATIENT. IT WAS REPORTED THAT THE CARDIOHELP SHOWED THE ALARM ¿PUMP DISPOSABLE ERROR -STOP". THE TRANSFER WAS RESUMED WHILE USING THE EMERGENCY DRIVE. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A THERE WAS A PUMP DISPOSABLE ERROR STOP DURING TREATMENT, AND THEREFORE THE EMERGENCY DRIVE WAS USED, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517963 ↗
• DeathMar 5, 2026Pressure Problem

  THE EVENT OCCURRED IN FINLAND DURING TREATMENT. IT WAS REPORTED THAT AN HLS SET CONNECTED TO A CARDIOHELP WAS PRIMED ACCORDING TO THE INSTRUCTIONS AND THE DEVICE WORKED NORMALLY AFTER CONNECTED TO THE PATIENT WHILE IN ANGIOGRAPHY. HOWEVER, ON A LATER POINT, WITHOUT ANY OBVIOUS CHANGE IN TREATMENT, THE VENOUS PRESSURE (PVEN) STOPPED APPEARING ON THE CARDIOHELP AND AN ALARM WAS DISPLAYED ¿VENOUS PRESSURE OUTSIDE OF THE ALARM LIMITS¿. THE TREATMENT WAS CONTINUED, THE FLOW REMAINED CONSTANT AND THE ARTERIAL, INTERNAL AND DELTA PRESSURE REMAINED CONSTANT. AN ATTEMPT WAS MADE BY THE CUSTOMER TO FIX THE PROBLEM BY REMOVING THE HLS CABLE FROM THE HLS MODULE AND CHECKING THE PINS AND IT WAS CONFIRMED THAT THERE WAS NO DIRT AND THE PINS WERE IN PLACE AND INTACT. ACCORDING TO THE CUSTOMER THE PVEN APPEARED FROM TIME TO TIME AND PRESSURE VALUES FROM +500 TILL +900 WERE DISPLAYED. ADDITIONALLY, THE PVEN ALSO SHOWED NEGATIVE VALUES. THE CUSTOMER CHANGED THE REVOLUTIONS, BUT THIS DID NOT AFFECT THE VENOUS PRESSURE. THE CUSTOMER MONITORED THE FLOW AND THE SUCTION EFFECT OF THE HOSES. IN ADDITION, TOWARDS THE END OF THE TREATMENT THE CARDIOHELP DISPLAYED THE ALARM ¿PVEN DISCONNECTED¿ A FEW TIMES. T

  Patient problems: Brain Injury

  MAUDE report 24517688 ↗
• MalfunctionMar 5, 2026Crack

  THE EVENT OCCURRED IN (B)(6) DURING PATIENT TRANSPORT. IT WAS REPORTED THAT THE SCREEN WAS CRACKED. THE CARDIOHELP DEVICE WAS REPLACED AFTER RETURNING INTO THE PATIENT¿S ROOM. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE CARDIOHELP DEVICE WAS REPLACED, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516694 ↗
• MalfunctionFeb 18, 2026Device Sensing Problem; Pressure Problem

  COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24374284 ↗
• MalfunctionFeb 4, 2026Pumping Stopped; Pressure Problem

  THE EVENT OCCURRED IN GERMANY DURING TREATMENT. IT WAS REPORTED THAT PVEN SUDDENLY DISPLAYED -500 MMHG AND THE PUMP STOPPED. THE E-DRIVE WAS USED AND THE CARDIOHELP WAS EXCHANGED. NO HARM TO ANY PERSON HAS BEEN REPORTED.AS THE E-DRIVE WAS USED AND THE CARDIOHELP WAS EXCHANGED A REPORT IS NEEDED.COMPLAINT ID:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257099 ↗
• MalfunctionFeb 3, 2026Pressure Problem

  IT WAS REPORTED THAT ERRONEOUS VENOUS/ARTERIAL PRESSURE READINGS WERE DISPLAYED DUE TO A DEFECTIVE SENSOR PANEL. THE EVENT OCCURRED DURING MAINTENANCE.NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE FAILURE WAS REPORTED, A REPORT IS NEEDED.COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244016 ↗
• MalfunctionJan 23, 2026Pressure Problem

  COMPLAINT ID:(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159357 ↗
• MalfunctionJan 16, 2026Electrical /Electronic Property Problem

  THE EVENT OCCURRED IN INDIA DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE VENOUS BUBBLE SENSOR IS DEFECTIVE. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A BUBBLE SENSOR DEFECTIVE ALARM COULD LEAD TO A ZERO-FLOW MODE, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091835 ↗
• MalfunctionDec 16, 2025Infusion or Flow Problem; Infusion or Flow Problem

  COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815832 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133598. One submission often covers many models, so check the product and lot details in each record.

• Z-1300-2026 · Jan 9, 2026 · Open, Classified
  Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
• Z-1053-2024 · Dec 28, 2023 · Open, Classified
  Bubble Sensor (REF: 70105.5720)
• Z-0290-2024 · Oct 12, 2023 · Open, Classified
  Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
• Z-0420-2024 · Oct 10, 2023 · Open, Classified
  CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
• Z-0897-2022 · Feb 18, 2022 · Open, Classified
  Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circ