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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 Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung syst...
Cardiac Devices·484 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 ho...
Medical Devices·461 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours ...
Medical Devices·26 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorpo...
Medical Devices·648 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours...
Medical Devices·1,096 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 ho...
Medical Devices·310 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung ...
Cardiac Devices·286 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours ...
Medical Devices·274 affected·Jun 18, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Produ...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root ...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Ca...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LON...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta duri...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula ...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch ...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the a...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placeme...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LO...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement ...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for place...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexib...
Medical Devices·33 affected·Oct 2, 2009
High RiskFDA
Terumo Cardiovascular Systems Corporation
Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the e...
Medical Devices·8 affected·Aug 12, 2009