Data / Medical devices / Germany / MAQUET CARDIOPULMONARY GmbH

MAQUET CARDIOPULMONARY GmbH: FDA-registered device maker in Rastatt Baden-Wurttemberg, Germany, 5 510(k) clearances

Name: MAQUET CARDIOPULMONARY GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

MAQUET CARDIOPULMONARY GmbH is registered with the FDA (registration 3009507273) in Rastatt Baden-Wurttemberg, Germany. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 21, 2014. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009507273
Address: Kehler Strasse 31, Rastatt Baden-Wurttemberg, Germany, 76437
Owner or operator: Maquet Cardiopulmonary GmbH (8010762)
Roles: Specification developer
First device listed: May 16, 1995
Registered through: 2026
Brand names listed: CARDIOHELP-i and multiple accessories, HL-20 Integrated Perfusion System, HL-20 Twin Pump, Holders, multiple, QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating, RotaFlow Centrifugal Pump, RotaFlow Centrifugal Pump System, Sprinter Cart (XL)

Devices it lists

Device	Product code	Class	Role	Source
Accessory Equipment, Cardiopulmonary Bypass	KRI	1	Specification developer	accessdata.fda.gov
Console, Heart-Lung Machine, Cardiopulmonary Bypass	DTQ	2	Specification developer	accessdata.fda.gov
Flowmeter, Blood, Cardiovascular	DPW	2	Specification developer	accessdata.fda.gov
Oxygenator, Cardiopulmonary Bypass	DTZ	2	Specification developer	accessdata.fda.gov
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	KFM	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 21, 2014	K133598	CARDIOHELP SYSTEM	DTQ	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
April 30, 2010	K100278	QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA	DTZ	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
August 31, 2000	K991864	ROTAFLOW CENTRIFUGAL PUMP SYSTEM	KFM	Substantially Equivalent	Jostra Medizintechnik AG	accessdata.fda.gov
August 19, 1999	K984338	JOSTRA HL-20 TWIN PUMP	DPW	Substantially Equivalent	Jostra Bentley	accessdata.fda.gov
January 30, 1996	K943803	JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM	DTQ	Substantially Equivalent	Janus Biomedical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 31, 2026	99668	Class II	Ongoing	Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS)	The packaging may not consistently maintain sterile barrier integrity.	accessdata.fda.gov
January 9, 2026	98159	Class II	Ongoing	Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720	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	accessdata.fda.gov
June 27, 2025	97097	Class II	Ongoing	Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.	Device does not comply with the labeling requirements of international standard IEC 60601-1.	accessdata.fda.gov
April 30, 2025	96820	Class II	Ongoing	Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.	HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.	accessdata.fda.gov
May 14, 2018	80076	Class II	Terminated	Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass	This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.	accessdata.fda.gov
April 4, 2018	79811	Class II	Terminated	CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital	There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.	accessdata.fda.gov

Compare with other makers

Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.