MAQUET CARDIOHELP CARDIOHELP Base Unit

• EUDAMED Basic UDI-DI B-04037691658247 registered 11 May 2026 Active
• FDA 510(k) K133598 decided 21 May 2014 Active
• FDA GUDID UDI-DI 04037691658247 listed 6 Nov 2015 Listed

• • Ongoing Z-1300-2026 FDA Class II ·initiated 9 Jan 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 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.

• • Ongoing Z-1831-2024 FDA Class II ·initiated 15 Apr 2024

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

• • Ongoing Z-1053-2024 FDA Class II ·initiated 28 Dec 2023

  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.

• • Ongoing Z-0595-2024 FDA Class III ·initiated 14 Nov 2023

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

• • Ongoing Z-0605-2024 FDA Class II ·initiated 13 Nov 2023

  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.

• • Ongoing Z-0555-2024 FDA Class II ·initiated 6 Nov 2023

  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

• • Ongoing Z-0290-2024 FDA Class II ·initiated 12 Oct 2023

  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.

• • Ongoing Z-0420-2024 FDA Class I ·initiated 10 Oct 2023

  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.

• • Ongoing Z-0897-2022 FDA Class II ·initiated 18 Feb 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 from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.

1. 18 Feb 2022 Recall initiated FDA recalls Z-0897-2022
2. 10 Oct 2023 Recall initiated FDA recalls Z-0420-2024
3. 12 Oct 2023 Recall initiated FDA recalls Z-0290-2024
4. 6 Nov 2023 Recall initiated FDA recalls Z-0555-2024
5. 13 Nov 2023 Recall initiated FDA recalls Z-0605-2024
6. 14 Nov 2023 Recall initiated FDA recalls Z-0595-2024
7. 28 Dec 2023 Recall initiated FDA recalls Z-1053-2024
8. 15 Apr 2024 Recall initiated FDA recalls Z-1831-2024
9. 9 Jan 2026 Recall initiated FDA recalls Z-1300-2026
10. 11 May 2026 Registered EUDAMED B-04037691658247

2 earlier events are in the sections above.

Trade name

CARDIOHELP Base Unit EUDAMED

Maquet Cardiohelp GUDID

Generic name

Cardiopulmonary bypass system, roller type

Model / Ref / Catalog

701047999 EUDAMED

CARDIOHELP Base Unit GUDID

70104.7999 GUDID

Primary DI / UDI-DI

04037691658247

Basic UDI-DI

B-04037691658247

510(k) Number

K133598 ↗

FDA product code

DTQ

EMDN code

Z12050201 Extra-corporeal circulation systems

GMDN term

Cardiopulmonary bypass system, roller type

Device class

Class IIb EUDAMED

Class II GUDID

Regulation number

870.4220

EU registration type

Legacy device (under a directive)

EU market of registration

Germany

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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• NA CARDIOHELP Holder for mast HKH 9102-M Open recall

  Class II

  FDA 510(k) K102726 Active Cleared 4 Apr 2011 GUDID on market

See all devices from Maquet Cardiopulmonary AG →