Terumo Cardiovascular Systems recalls

Terumo Cardiovascular Systems appears in 223 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT…
  FDA Device · Class II · 2013-11-27 · Terumo Cardiovascular Systems
• Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long
  FDA Device · Class II · 2013-11-20 · Terumo Cardiovascular Systems
• Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD wit…
  FDA Device · Class II · 2013-11-20 · Terumo Cardiovascular Systems
• Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD wit…
  FDA Device · Class II · 2013-11-20 · Terumo Cardiovascular Systems
• Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with…
  FDA Device · Class II · 2013-11-20 · Terumo Cardiovascular Systems
• Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardio…
  FDA Device · Class II · 2013-10-02 · Terumo Cardiovascular Systems
• Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for us…
  FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems
• 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circ…
  FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems
• Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is ind…
  FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems
• 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circ…
  FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems
• Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use…
  FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems
• Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use…
  FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems
• CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe
  FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems
• CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module
  FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems
• CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules
  FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems
• CDI Blood Parameter Monitoring System 500 with Venous blood parameter module
  FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems
• CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe
  FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems
• Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for bloo…
  FDA Device · Class II · 2013-07-03 · Terumo Cardiovascular Systems
• Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System
  FDA Device · Class II · 2013-02-20 · Terumo Cardiovascular Systems
• Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns&a…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns&am…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns&am…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns&am…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• 18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary by…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• 24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary by…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary b…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• 24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• 18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary byp…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• 24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary by…
  FDA Device · Class II · 2012-12-12 · Terumo Cardiovascular Systems
• 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the…
  FDA Device · Class II · 2012-12-05 · Terumo Cardiovascular Systems
• 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the…
  FDA Device · Class II · 2012-12-05 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6…
  FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems
• Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperatu…
  FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6…
  FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6…
  FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6…
  FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up…
  FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems
• HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature con…
  FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up…
  FDA Device · Class II · 2012-11-21 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h…
  FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h…
  FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h…
  FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up t…
  FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up t…
  FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems
• Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h…
  FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems
• Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible re…
  FDA Device · Class II · 2012-10-24 · Terumo Cardiovascular Systems
• Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures on…
  FDA Device · Class II · 2012-10-17 · Terumo Cardiovascular Systems