RegWardenFDA facility compliance records
Company

Maquet Cardiopulmonary GmbH

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

Recalls by year

FDA actions on record by year2018: 2 recalls; 2025: 2 recalls; 2026: 2 recalls2017220182019202020212022202320242202522026
  • Recalls (6)

Registered facilities (2)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Maquet Cardiopulmonary GmbH — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8010762-maquet-cardiopulmonary-gmbh/

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