Maquet Cardiopulmonary Gmbh
Neue Rottenburger Strasse 37, Hechingen Baden-Wurttemberg, DE
Registered product codes
9 product codes
Recent MDR events
4,477 on file
- HLS Cannula & PIKJul 31, 2026Malfunction8010762-2026-0000418
- CardiohelpJul 30, 2026Malfunction8010762-2026-0000414
- Heart Lung MachineJul 30, 2026Injury8010762-2026-0000415
- Heart Lung MachineJul 30, 2026Injury8010762-2026-0000416
- CardiohelpJul 30, 2026Malfunction8010762-2026-0000419
- CardiohelpJul 30, 2026Malfunction8010762-2026-0000420
- Tubing SetJul 29, 2026Malfunction8010762-2026-0000408
- Tubing SetJul 29, 2026Malfunction8010762-2026-0000409
- Heart Lung MachineJul 29, 2026Malfunction8010762-2026-0000410
- Heart Lung MachineJul 29, 2026Malfunction8010762-2026-0000411
Recalls
2 on file
- Open, ClassifiedFeb 5, 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.
View FDA record ↗ - Open, ClassifiedJul 29, 2025
Device does not comply with the labeling requirements of international standard IEC 60601-1.
View FDA record ↗
Compliance history
Matched by FEI 3009649876.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.