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Terumo Cardiovascular Systems Corporation Recalls

124 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Terumo Cardiovascular Systems Corporation.

124Total Recalls
0Critical
2.0MUnits Affected
May 28, 2025Most Recent
All Recalls

Every Terumo Cardiovascular Systems Corporation Recall

Sorted by most recent. Click any recall for full details.

124 recalls
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Medical Devices·28 affected·May 28, 2025
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Respiratory Devices·37 affected·Mar 3, 2025
High RiskFDA
Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 6638...
Medical Devices·20,533 affected·Feb 20, 2024
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Respiratory Devices·84 affected·Mar 1, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Respiratory Devices·4,940 affected·Mar 1, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Respiratory Devices·1,412 affected·Mar 1, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for...
Medical Devices·995 affected·Apr 16, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an ext...
Medical Devices·1,176 affected·Apr 16, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm w...
Medical Devices·12 affected·Mar 2, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25...
Respiratory Devices·5,079 affected·Nov 11, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and ...
Cardiac Devices·2 affected·Aug 25, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and ...
Cardiac Devices·100 affected·Aug 25, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in th...
Medical Devices·11 affected·Jan 10, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in ...
Medical Devices·33 affected·Jan 10, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Respiratory Devices·16 affected·Jun 14, 2019
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold onl...
Respiratory Devices·123 affected·Jun 14, 2019
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender prov...
Respiratory Devices·1,258 affected·Apr 18, 2019
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Medical Devices·152 affected·Sep 13, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monit...
Respiratory Devices·128 affected·Jun 26, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHC...
Respiratory Devices·128 affected·Jun 26, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling a...
Medical Devices·2,393 affected·Mar 16, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to ...
Medical Devices·3,794 affected·Feb 20, 2017
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers...
Medical Devices·6,412 affected·Jun 8, 2016
High RiskFDA
Terumo Cardiovascular Systems Corporation
Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm wa...
Cardiac Devices·6,412 affected·Jun 8, 2016
High RiskFDA
Terumo Cardiovascular Systems Corporation
HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent w...
Cardiac Devices·6,412 affected·Jun 8, 2016
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provid...
Respiratory Devices·222 affected·Mar 14, 2016
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and ...
Respiratory Devices·4,638 affected·Aug 7, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on t...
Medical Devices·1,713 affected·May 1, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on t...
Medical Devices·1,713 affected·May 1, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temper...
Medical Devices·103 affected·Feb 6, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Medical Devices·1,713 affected·Jun 17, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarn...
Medical Devices·7,460 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: ...
Medical Devices·7,190 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula ...
Medical Devices·6,720 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Ven...
Medical Devices·34,470 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusio...
Medical Devices·120 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion o...
Medical Devices·3,040 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: ...
Medical Devices·2,290 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicate...
Medical Devices·135,340 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed int...
Medical Devices·1 affected·May 9, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Medical Devices·0 affected·Apr 14, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass proced...
Medical Devices·0 affected·Apr 14, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venou...
Surgical Devices·0 affected·Mar 3, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Ven...
Surgical Devices·0 affected·Mar 3, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus ...
Medical Devices·26 affected·Dec 12, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD ...
Medical Devices·30 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAI...
Medical Implants·9 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD ...
Medical Devices·70 affected·Oct 23, 2013