# K102726: Cardiohelp System

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Apr 4, 2011 after 195 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K922933 (1992). 97 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943803: Jostra HL-20 Integrated Perfusion System, Janus Biomedical, Inc. (1996) Summary page 2.
- K991864: Rotaflow Centrifugal Pump System, Jostra Medizintechnik AG (2000) Summary page 2.
- K090006: Lifebridge B2T, Model 7001, Lifebridge Medizintechnik AG (2009) Summary page 2.
- K083111: Impella 5.0 Catheter Family, Abiomed, Inc. (2009) Summary page 2.
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100, Levitronix, LLC (2003) Summary page 2.
- K061369: Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500, Cardiacassist, Inc. (2006) Summary page 2.
- K080470: Rota Flow Centrifugal Pump with Bioline Coating, Models BE-RF-32, Beq-RF-32, Maquet Cardiopulmonary, AG (2008) Summary page 2.
- K071774: Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000, Beq-Hmod 2030, Maquet Cardiopulmonary, AG (2008) Summary page 2.
- K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000, Maquet Cardiopulmonary, AG (2009) Summary page 2.
- K093522: Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/ Integrated Arterial Filter W/ Bioline C, Maquet Cardiopulmonary, AG (2009) Summary page 2.
- K080592: HLM Tubing Set with Bioline Coating, Maquet Cardiopulmonary, AG (2008) Summary page 2.
- K090533: HLM Tubing Set with Softline Coating, Maquet Cardiopulmonary, AG (2009) Summary page 2.
- K090147: Blood Monitoring Unit, Model Bmu 40, Maquet Cardiopulmonary, AG (2009) Summary page 2.

## Most influential descendants
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own

## Recalls of this device
- Apr 30, 2025 · Class II · Z-1823-2025: HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
- May 18, 2023 · Class II · Z-1643-2023: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both i
- May 18, 2023 · Class II · Z-1662-2023: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, 
- Feb 8, 2019 · Class I · Z-0986-2019: Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
- Apr 4, 2018 · Class II · Z-1642-2018: There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
- Feb 23, 2016 · Class II · Z-1372-2016: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
- Mar 5, 2015 · Class II · Z-1690-2015: A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubi
- Oct 17, 2014 · Class II · Z-0211-2015: Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power
- Sep 12, 2013 · Class II · Z-0082-2014: It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upo
- Mar 7, 2013 · Class II · Z-1149-2013: It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHE

## Indications for use
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

Source page: https://510kreport.com/device/K102726
Methodology: https://510kreport.com/methodology