MAQUET CARDIOHELP CARDIOHELP-iRecalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 04058863074863), received between Oct 12, 2023 and Sep 28, 2026 — classified as 2 deaths, 62 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (16 reports).

5 FDA recall records name this device's identifier, 5 still open.

4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Nov 14, 2023Open, Classified

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

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

2. 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 · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. Oct 12, 2023Open, Classified

   It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

   Z-0290-2024 · Root cause: Device Design · Recall details · FDA record ↗

5. Feb 18, 2022Open, Classified

   Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.

   Z-0897-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  The event occurred in USA with no patient involvement. 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 50910894 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Infusion or Flow Problem

  The event occurred in USA during training, with no patient involvement. It was reported that the RPM changed speeds randomly when demonstrating the disposable disconnect. No harm to any person has been reported. As a Flow Bubble Sensor issue or flow issue, can lead to a pump stop, if the intervention is set by the user, a report is required. Complaint (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868009 ↗
• MalfunctionSep 22, 2026Mechanical Problem

  The event occurred in the USA during visual inspection with no patient involvement. It was reported that there was a visible crack on the body of the flow bubble sensor. 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 50852616 ↗
• MalfunctionSep 16, 2026Mechanical Problem

  The event occurred in the USA. The failure was found prior to use. It was reported that two pins on a cable are bent and one is broken in half. No harm to any person has been reported. Additional information was received that the Cardiohelp came back from system restore with this damage. The affected cable is the cable of the flow bubble sensor, which was damaged during transport from system restore. As a damaged Flow bubble sensor 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 50784959 ↗
• MalfunctionSep 9, 2026Mechanical Problem

  It was reported that Emergency Drive was broken during use however customer does not want to provide demographics. Later it was found that the latch of the emergency drive was sticky and therefore was not moving. No harm to any person has been reported. As there is a potential Risk, that in emergency situations the patient cannot be supported via the HLS Set and Emergency drive till a new Cardiohelp is connected, a report is required. Complaint # (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684120 ↗
• MalfunctionSep 8, 2026Electrical /Electronic Property Problem

  The event occurred in USA during treatment. It was reported that the venous bubble sensor failed. The venous bubble sensor was switched out. 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 50665634 ↗
• MalfunctionSep 2, 2026Electrical /Electronic Property Problem; Pumping Stopped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562811 ↗
• MalfunctionSep 2, 2026Device Alarm System; Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559083 ↗
• MalfunctionAug 5, 2026False Alarm

  Complaint # (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50138345 ↗
• MalfunctionMar 24, 2026Failure to Read Input Signal

  THE FAILURE WAS DETECTED WITH NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE FLOW PROBE (FLOW BUBBLE SENSOR) IS NOT WORKING. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS ANY FLOW ISSUE AND BUBBLE ALARM IS A HIGH PRIORITY ALARM, WHICH LEADS TO PUMP STOP, IF INTERVENTION IS SET BY THE USER, A REPORT IS NEEDED. COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679436 ↗
• MalfunctionMar 18, 2026Corroded; Pressure Problem

  THE EVENT OCCURRED IN USA DURING A TRAINING. IT WAS REPORTED THAT THE PRESSURES COULD NOT BE ZEROED. THE CUSTOMER STATED THAT THE HLS CABLE IS GIVING ERRATIC PRESSURE VALUES ACROSS MULTIPLE CIRCUITS. THE CUSTOMER BELIEVES THAT THE HLS CABLE IS TWISTED AND BENT AND SUSPECTS IT IS DAMAGED. 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 ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626028 ↗
• MalfunctionMar 5, 2026Device Sensing Problem

  THE EVENT OCCURRED IN USA DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE ¿VENOUS BUBBLE SENSOR DEFECTIVE¿ ERROR MESSAGE WAS DISPLAYED. THE CARDIOHELP DEVICE WAS NOT REPLACED, THE VENOUS BUBBLE SENSOR WAS CHANGED WITH ANOTHER BUBBLE SENSOR THAT WORKED. FURTHER IT WAS CONFIRMED THAT THERE WAS NO VISIBLE DAMAGE ON THE VENOUS BUBBLE SENSOR OR ITS CABLE. 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 AS THERE IS BARELY A FLOW. COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516685 ↗
• MalfunctionMar 3, 2026Failure to Read Input Signal

  THE EVENT OCCURRED IN THE USA. IT WAS REPORTED, THAT THE CARDIOHELP ALARMED "VENOUS BUBBLE SENSOR DEFECTIVE" DURING TREATMENT. THE CUSTOMER USED ANOTHER SENSOR AND THIS SOLVED THE FAILURE. THE DEFECTIVE VENOUS BUBBLE SENSOR SHOWS A SLIGHT FRAYING ON THE CORD. THE CARDIOHELP WAS NOT REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495160 ↗
• MalfunctionFeb 17, 2026Device Sensing Problem; Infusion or Flow Problem

  COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362235 ↗
• MalfunctionFeb 4, 2026Obstruction of Flow; Infusion or Flow Problem; Pressure Problem; Noise, Audible

  COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257059 ↗
• MalfunctionJan 20, 2026Crack

  COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114291 ↗
• MalfunctionDec 24, 2025Failure to Charge; Charging Problem; Power Problem; Failure to Charge; Charging Problem; Power Problem

  COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886534 ↗
• MalfunctionDec 4, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WERE ISSUES GETTING A FLOW READING FROM THE CARDIOHELP DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THERE WAS A FLOW ISSUE DURING TREATMENT, WHICH CAN CAUSE A PUMP STOP IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715507 ↗
• MalfunctionDec 4, 2025Failure to Read Input Signal; Failure to Read Input Signal

  COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714247 ↗
• MalfunctionNov 25, 2025Crack; Crack

  COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642385 ↗
• MalfunctionNov 24, 2025Pumping Stopped; Pressure Problem; Pumping Stopped; Pressure Problem

  COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630406 ↗
• MalfunctionNov 6, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484166 ↗
• MalfunctionOct 17, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE EVENT OCCURRED IN USA DURING TREATMENT. IT WAS REPORTED THAT THE CARDIOHELP SCREEN WAS NOT RESPONDING. WHEN INCREASING OR DECREASING RPM'S VIA THE ROTARY KNOB, THE SCREEN WAS NOT SHOWING THE INCREASE/DECREASE, HOWEVER, THE LED RPM'S AT THE TOP OF THE PUMP WAS SHOWING THE INCREASE/DECREASE OF RPM'S. CUSTOMER TRIED TO USE THE TOUCHSCREEN TO INCREASE/DECREASE THE RPM'S WITH NO RESPONSE. THERE WAS NO VISIBLE CRACK OR DENT ON THE SCREEN. THE CUSTOMER WAS ABLE TO SWITCH THE HLS SET TO A NEW CARDIOHELP. NO HARM TO ANY PERSON WAS REPORTED. AS THE DEVICE WAS REPLACED DURING TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322915 ↗
• MalfunctionOct 17, 2025Pressure Problem; Pressure Problem

  THE EVENT OCCURRED IN THE USA. IT WAS REPORTED THAT THERE WAS A PRESSURE READING ISSUE. 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 23322911 ↗
• MalfunctionSep 8, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT THE HLS CABLE IS READING DISCONNECTED, WHILE CONNECTED. THE FAILURE OCCURRED WITHOUT PATIENT INVOLVEMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE ISSUE WAS REPORTED, WHICH IS A POTENTIAL RISK FOR THE PATIENT, A REPORT IS NEEDED. COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990902 ↗

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-1831-2024 · Apr 15, 2024 · Open, Classified
  CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
• Z-1053-2024 · Dec 28, 2023 · Open, Classified
  Bubble Sensor (REF: 70105.5720)
• 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.