# K133598: Cardiohelp System

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: May 21, 2014 after 180 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K922933 (1992). 98 ancestors in all.
No later device cites it as a predicate yet.
3 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102726: Cardiohelp System, Maquet Cardiopulmonary, AG (2011) Summary page 1.

## Recalls of this device
- Jan 9, 2026 · Class II · Z-1300-2026: 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
- Apr 15, 2024 · Class II · Z-1831-2024: The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
- Dec 28, 2023 · Class II · Z-1053-2024: 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.
- Nov 14, 2023 · Class III · Z-0595-2024: CARDIOHELP-i System was not properly tested to measure leakage current
- Nov 13, 2023 · Class II · Z-0605-2024: 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 suppor
- Nov 6, 2023 · Class II · Z-0555-2024: 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 autom
- Oct 12, 2023 · Class II · Z-0290-2024: 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 w
- Oct 10, 2023 · Class I · Z-0420-2024: 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 a
- Feb 18, 2022 · Class II · Z-0897-2022: 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 

## 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 CARDIOI-ELP 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/K133598
Methodology: https://510kreport.com/methodology