Terumo Cardiovascular Systems Corporation
FDA Regulatory Profile
Terumo Cardiovascular Systems Corporation appears in FDA public data with 204 recalls, 29 510(k) clearances, 16 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2018-2025, Class II) was initiated on May 28, 2025. Its most recent 510(k) clearance was granted on April 25, 2024.
Summary
- Total Recalls
- 204
- 510(k) Clearances
- 29
- Inspections
- 16
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2018-2025 | Class II | CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI O | May 28, 2025 |
| Z-1492-2025 | Class II | Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 | March 3, 2025 |
| Z-1401-2024 | Class II | Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16 | February 20, 2024 |
| Z-1346-2023 | Class II | CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE | March 1, 2023 |
| Z-1347-2023 | Class II | CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC | March 1, 2023 |
| Z-1345-2023 | Class II | CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 | March 1, 2023 |
| Z-2350-2021 | Class II | Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 | June 8, 2021 |
| Z-1791-2021 | Class II | The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used | April 16, 2021 |
| Z-1790-2021 | Class II | The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for | April 16, 2021 |
| Z-1789-2021 | Class II | The Terumo HX2 Temperature Management System provides temperature control of two independent water c | April 16, 2021 |
| Z-1367-2021 | Class II | Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft | March 2, 2021 |
| Z-0565-2021 | Class II | (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advan | November 11, 2020 |
| Z-2960-2020 | Class II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Pro | August 25, 2020 |
| Z-2959-2020 | Class II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usa | August 25, 2020 |
| Z-2961-2020 | Class II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usa | August 25, 2020 |
| Z-1108-2020 | Class II | Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is in | January 10, 2020 |
| Z-1110-2020 | Class II | Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use f | January 10, 2020 |
| Z-1111-2020 | Class II | Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indi | January 10, 2020 |
| Z-1109-2020 | Class II | Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is in | January 10, 2020 |
| Z-2101-2019 | Class II | Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE | June 14, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K234065 | CDI OneView Monitoring System | April 25, 2024 |
| K221895 | Terumo Advanced Perfusion System 1 | April 18, 2023 |
| K200091 | Capiox iCP Centrifugal Pump | November 18, 2021 |
| K182110 | CDI Blood Parameter Monitoring System 550 | November 2, 2018 |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with | June 22, 2018 |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator wit | March 29, 2018 |
| K172220 | Advanced Perfusion System 1 | August 17, 2017 |
| K163531 | Advanced Perfusion System 1 | June 7, 2017 |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Teru | November 17, 2016 |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | April 21, 2016 |
| K153376 | Advanced Perfusion System 1 | December 16, 2015 |
| K153213 | Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir | December 3, 2015 |
| K153143 | Capiox Advance Hardshell Reservoir | December 2, 2015 |
| K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox F | November 19, 2015 |
| K151389 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir | October 20, 2015 |
| K151349 | Advanced Perfusion System 1 | August 27, 2015 |
| K150536 | Terumo Circuit Tubing | May 5, 2015 |
| K150542 | Terumo Pump Tubing | May 1, 2015 |
| K142500 | One Way Soft Valve | January 29, 2015 |
| K140008 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM | October 31, 2014 |