The FDA has posted 5 enforcement recalls from Maquet Cardiopulmonary Gmbh since 2025, none of them Class I (most serious). Most recent report: Sep 23, 2026.
The packaging may not consistently maintain sterile barrier integrity.
The packaging may not consistently maintain sterile barrier integrity.
The packaging may not consistently maintain sterile barrier integrity.
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor.…
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Firm name as filed with the FDA: “Maquet Cardiopulmonary Gmbh”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.