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Terumo Cardiovascular Systems Recalls
223 recalls on record · June 27, 2012 to July 2, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 16, 2015Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressu
Hazard: Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
July 1, 2015Medical DevicesFDA
Terumo Cardiovascular Systems Corp recalls Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the
Hazard: The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
June 3, 2015Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for u
Hazard: Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: - Implementing design changes and upgrades to improve the reliability of power switching and battery backup. - Adding a switch protector to the On/Off power switch to preven
June 3, 2015Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for u
Hazard: Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: - Implementing design changes and upgrades to improve the reliability of power switching and battery backup. - Adding a switch protector to the On/Off power switch to preven
February 25, 2015Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly co
Hazard: Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.
November 12, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corp recalls Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multipl
Hazard: Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line
November 12, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corp recalls Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia
Hazard: Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
November 12, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corp recalls Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the di
Hazard: Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.
November 12, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corp recalls Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets ar
Hazard: Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
November 12, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corp recalls Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage:
Hazard: Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
November 12, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corp recalls Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Us
Hazard: Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoati
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls 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.
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" f
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls 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 Pr
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for u
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venou
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Ca
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indic
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated fo
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 30, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product
Hazard: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
July 23, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use.
Hazard: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
July 23, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonar
Hazard: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
July 23, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmon
Hazard: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
July 16, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Hazard: An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
July 16, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Hazard: An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
May 28, 2014Medical DevicesFDA
Terumo Cardiovascular Systems Corporation recalls CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B0155
Hazard: There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing accep