Facility

MAQUET CARDIOPULMONARY GmbH

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009507273
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Kehler Strasse 31 Rastatt Baden-Wurttemberg, DE 76437
Registration status	Active · expires 2026
Parent company	Maquet Cardiopulmonary GmbH (owner-operator 8010762)
Brand names	HL-20 Integrated Perfusion System

Activity by year

Recalls (6)
Inspections (1)

Devices registered here (1)

Console, Heart-Lung Machine, Cardiopulmonary Bypass
Product code DTQ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4220

Recalls & enforcement

Class IIOngoing2026-07-31
The packaging may not consistently maintain sterile barrier integrity.
Class IIOngoing2026-01-09
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 th…
Class IIOngoing2025-06-27
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Class IIOngoing2025-04-30
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Class IITerminated2018-05-14
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.
Class IITerminated2018-04-04
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.

FDA inspections (1)

NAI2022-04-28
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MAQUET CARDIOPULMONARY GmbH (FEI 3009507273) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009507273-maquet-cardiopulmonary-gmbh/

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