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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
Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass...
Medical Devices·40 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD wi...
Medical Devices·90 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporea...
Medical Devices·1,657 affected·Jul 26, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Card...
Medical Devices·15,817 affected·Jul 26, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1...
Medical Devices·1,657 affected·Jul 26, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporea...
Medical Devices·1,657 affected·Jul 26, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for...
Medical Devices·7 affected·May 30, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedu...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use dur...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedure...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended f...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns&...
Medical Devices·6,830 affected·Jan 7, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&am...
Medical Devices·6,830 affected·Jan 7, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns&a...
Medical Devices·6,830 affected·Jan 7, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp...
Medical Devices·6,830 affected·Jan 7, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary b...
Medical Devices·5,760 affected·Nov 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmona...
Medical Devices·5,760 affected·Nov 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmona...
Medical Devices·5,760 affected·Nov 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary b...
Medical Devices·5,760 affected·Nov 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours o...
Medical Devices·1,647 affected·Nov 14, 2012
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 o...
Medical Devices·1,647 affected·Nov 14, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperatur...
Medical Devices·19 affected·Oct 16, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temp...
Medical Devices·15 affected·Oct 16, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up ...
Medical Devices·26 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass pro...
Medical Devices·289 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass...
Medical Devices·1,076 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for...
Medical Devices·312 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up ...
Medical Devices·274 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up t...
Medical Devices·81 affected·Sep 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass proced...
Medical Devices·126 affected·Sep 24, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedur...
Medical Devices·847 affected·Sep 24, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, region...
Medical Devices·72 affected·Sep 20, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in ext...
Medical Devices·150 affected·Sep 10, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial...
Medical Devices·649 affected·Jul 26, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer...
Medical Devices·579 affected·Jul 26, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial...
Medical Devices·992 affected·Jul 26, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and ...
Medical Devices·582 affected·Jul 26, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation...
Medical Devices·648 affected·Jun 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation...
Medical Devices·992 affected·Jun 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulatio...
Medical Devices·648 affected·Jun 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation...
Medical Devices·992 affected·Jun 25, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the ...
Respiratory Devices·1,095 affected·Jun 22, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 h...
Medical Devices·648 affected·Jun 22, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6...
Respiratory Devices·648 affected·Jun 22, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6...
Medical Devices·992 affected·Jun 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6...
Medical Devices·648 affected·Jun 21, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulati...
Medical Devices·992 affected·Jun 21, 2012
RecallFDA
Terumo Cardiovascular Systems Corporation
System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal...
Medical Devices·3 affected·Jun 20, 2012