Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2024, with 204 FDA device recalls on record.
Top product codes for Terumo Cardiovascular Systems Corporation
FDA recalls by Terumo Cardiovascular Systems Corporation
10 most recent of 204- Z-2018-2025 — CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
- Z-1492-2025 — Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
- Z-1401-2024 — Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534 75607 75765 75797 75833 75903 75956 75973 76131 76178 76278 76306 76398 76427 76498 76519 76536 76565 76575 76628 76630 76635 76644 76687 76725 76775 76789 76832 76839 76878 76900 76999 77010 77014 77015 77105 77227 77299 77304 77305 77412 77450 77496 77516 77629 77722 77742 77757 77791 77794 77796 78018 78027 165720 205307A 65046-03 65080-06 65167-06 65934-01 65940-01 66041-01 66154-01 66503-02 70148-02 70178-06 70188-05 70638-07 70664-02 70665-01 70734-03 71064-01 71432-02 71433-01 71546-02 71733-02 71754-04 71801-02 71820-01 71928-06 71934-04 72073-02 72149-01 72226-06 72326-07 73008-02 73346-01 73567-01 73568-01 73776-04 73783-02 73882-03 74172-03 74685-01 74734-01 74833-01 74879-07 74921-02 74965-03 74965-04 74972-01 75030-01 75050-02 75068-01 75159-01 75293-01 75409-01 75409-02 75410-01 75410-02 75540-03 75540-05 75572-01 75642-02 75688-01 75790-02 75834-01 75927-01 75959-01 75972-01 76178-01 76273-01 76278-01 76308-01 76326-02 76372-01 76373-01 76374-01 76376-01 76491-01 76732-02 76873-02 77012-02 77127-01 77316-01 77496-01 77502-01 77521-01 77532-01 77655-01 77791-01 B75409 B75410 B75903 B76178 B76278
- Z-1347-2023 — CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
- Z-1345-2023 — CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
- Z-1346-2023 — CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
- Z-2350-2021 — Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
- Z-1790-2021 — The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940
- Z-1791-2021 — The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940) TCM (P/N 15747) Catalog Number: 4415, 164925, 164930, 164935, 15747
- Z-1789-2021 — The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to circulate water at a rate of up to 6.5 gal./min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Device Name / Model Number: HX2 Temperature Management System (P/N 809810) Catalog Number: 809810
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Terumo Cardiovascular Systems Corporation
- K234065 — CDI OneView Monitoring System
- K221895 — Terumo Advanced Perfusion System 1
- K200091 — Capiox iCP Centrifugal Pump
- K182110 — CDI Blood Parameter Monitoring System 550
- K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
- K172071 — Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
- K172220 — Advanced Perfusion System 1
- K163531 — Advanced Perfusion System 1
- K162843 — Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
- K160206 — VirtuoSaph Plus Endoscopic Vessel Harvesting System
- K153376 — Advanced Perfusion System 1
- K153213 — Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
- K153143 — Capiox Advance Hardshell Reservoir
- K151791 — Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir
- K151389 — Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
- K151349 — Advanced Perfusion System 1
- K150536 — Terumo Circuit Tubing
- K150542 — Terumo Pump Tubing
- K142500 — One Way Soft Valve
- K140008 — VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
- K140774 — TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
- K132811 — SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
- K131618 — LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
- K121209 — TERUMO PALL AL20X ARTERIAL FILTER
- K093992 — TERUMO LAUER LOCK ADAPTER
- K041697 — TERUMO CIRCUIT CONNECTORS
- K033800 — CAPIOX CARDIOTOMY RESERVOIR
- K022918 — ADAPTERS WITH X-COATING
- K022857 — PUMP TUBING WITH X-COATING
Data sourced from openFDA. This site is unofficial and independent of the FDA.