MAQUET CARDIOHELPRecalls & reported problems across all models
Maquet Cardiopulmonary AG · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
9 open recalls name at least one MAQUET CARDIOHELP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 173
- Deaths reported
- 20
- Injuries reported
- 8
- Recalls
- 9
We found 5 models of MAQUET CARDIOHELP by Maquet Cardiopulmonary AG in the FDA's device registry (GUDID). Together they are named in 173 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2023 and Sep 30, 2026 — classified as 20 deaths, 8 injuries, 145 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (47 reports).
9 FDA recall records name at least one of these models by its device identifier, 9 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
Reports received per month, all models
MAQUET CARDIOHELP 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.
- Jan 9, 2026Open, Classified
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
Z-1300-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- Dec 28, 2023Open, Classified
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
Z-1053-2024 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Nov 14, 2023Open, Classified
CARDIOHELP-i System was not properly tested to measure leakage current
Z-0595-2024 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗
- 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 · names 2 of these models · Recall details · FDA record ↗
- 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 · names 2 of these models · Recall details · FDA record ↗
- 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 ↗
- Oct 10, 2023Open, Classified
Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.
Z-0420-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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 MAQUET CARDIOHELP problems
Device problems
- Pressure Problem47
- Failure to Read Input Signal24
- Infusion or Flow Problem17
- Electrical /Electronic Property Problem16
- Pumping Stopped14
- Adverse Event Without Identified Device or Use Problem10
- Crack9
- Insufficient Device Problem Information9
Patient problems
- No Clinical Signs, Symptoms or Conditions146
- Hemorrhage/Blood Loss/Bleeding8
- Arrhythmia4
- Bone Fracture(s)4
- Insufficient Information4
- Asystole2
- Brain Injury2
- Heart Failure/Congestive Heart Failure2
MAQUET CARDIOHELP models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAQUET CARDIOHELP CARDIOHELP-iCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS5 recalls2 deaths64 reports
- MAQUET CARDIOHELP CARDIOHELP SystemCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS4 recalls18 deaths107 reports
- MAQUET CARDIOHELP BS 3/8x3/32 L1.7Console, Heart-Lung Machine, Cardiopulmonary Bypass2 recalls0 reports
- MAQUET CARDIOHELP CARDIOHELP Emergency Drive (w/o holder)CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall0 reports
- MAQUET CARDIOHELP CARDIOHELP Base UnitCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS2 reports
Recent MAQUET CARDIOHELP adverse event reports
The 15 most recent reports across all models, 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 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 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 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 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 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 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 ↗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 ↗
Other Maquet Cardiopulmonary AG products
All Maquet Cardiopulmonary AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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