Maquet Cardiopulmonary Gmbh
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 44
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1300-2026 | Class II | Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720; | January 9, 2026 |
| Z-2193-2025 | Class II | Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags. | June 27, 2025 |
| Z-1823-2025 | Class II | Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system fo | April 30, 2025 |
| Z-2159-2018 | Class II | Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206 | May 14, 2018 |
| Z-2161-2018 | Class II | Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002 | May 14, 2018 |
| Z-2160-2018 | Class II | Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 70100 | May 14, 2018 |
| Z-1642-2018 | Class II | CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Ca | April 4, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | May 7, 2015 |
| K140569 | ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) | November 19, 2014 |
| K141432 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEO | July 7, 2014 |
| K133598 | CARDIOHELP SYSTEM | May 21, 2014 |
| K133265 | QUADROX-IR ADULT AND SMALL ADULT | November 12, 2013 |
| K132166 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, V | October 30, 2013 |
| K132829 | QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS | October 8, 2013 |
| K131666 | ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING | July 5, 2013 |
| K130300 | HEATER-COOLER UNIT HCU 40 | July 1, 2013 |
| K123288 | HEMOCONCENTRATOR | June 26, 2013 |
| K130639 | ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER | May 16, 2013 |
| K112360 | QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERI | September 15, 2011 |
| K102726 | CARDIOHELP SYSTEM | April 4, 2011 |
| K102919 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEO | March 11, 2011 |
| K103191 | QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / | March 8, 2011 |
| K102464 | QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIO | March 4, 2011 |
| K102532 | HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING | February 25, 2011 |
| K101153 | QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ- | December 8, 2010 |
| K100278 | QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, B | April 30, 2010 |
| K090534 | VENOUS HARDSHELL CARDIOTOMY RESERVIORS | December 23, 2009 |