The Recall Desk

Manufacturer

Terumo Cardiovascular Systems Corporation

204 recalls in our database name Terumo Cardiovascular Systems Corporation as the manufacturing or recalling firm.

What the numbers show

Total
204
Critical
0
Severe
20
Most recent
2025-07-02

Of the 204 recalls from Terumo Cardiovascular Systems Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

126–150 of 204

  • HighFDA (Devices)·Z-0127-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 1,097 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0129-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 312 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, wh
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0130-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 26 units of the Sarns Modular Perfusion System 8000 due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0128-2013·2012-10-31

    Terumo Sarns Modular Perfusion System 8000 Recalled for Power Malfunctions

    Terumo CVS is recalling 466 Sarns Modular Perfusion System 8000 units due to reported power distribution and battery back-up malfunctions.

    Product
    Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, wh
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-0071-2013·2012-10-24

    Terumo Backplate Replacement CXFVR 1500 Holder Recalled for Incorrect Configuration

    Terumo is recalling 33 Backplate Replacement CXFVR 1500 Holders because they were manufactured with an incorrect configuration of connector supports.

    Product
    Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines tha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0050-2013·2012-10-17

    Terumo Sarns Centrifugal System Battery Backup Recall

    Terumo CVS is recalling 289 Sarns Centrifugal System battery backups due to reported malfunctions that could cause unexpected loss of arterial flow.

    Product
    Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Devices)·Z-0049-2013·2012-10-17

    Terumo Sarns Centrifugal System Battery Backup Recall for Malfunctions

    Terumo CVS is recalling Sarns Centrifugal System batteries due to reports of charging and operational failures that could cause loss of arterial flow.

    Product
    Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Devices)·Z-0051-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0053-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0052-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2449-2012·2012-10-03

    Terumo Advanced Perfusion System 1 Flow Module Recalled for Display Malfunction

    Terumo is recalling 72 Flow Modules for the Advanced Perfusion System 1 because they may fail to display blood flow information or illuminate the LED indicator.

    Product
    Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2443-2012·2012-10-03

    Terumo Advanced Perfusion System 1 Flow Pod Recall for False Alarms

    Terumo is recalling 150 Advanced Perfusion System 1 Flow Pods due to a circuit board defect that causes false back flow alarms when tubing is absent.

    Product
    Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualifie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2012·2012-09-19

    Terumo Sarns Modular Perfusion System 8000 Safety Monitor Recall

    Terumo is recalling eight Sarns Modular Perfusion System 8000 safety monitors due to an underrated circuit breaker that may cause the device to trip off.

    Product
    Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2230-2012·2012-08-29

    Terumo Serial Interface Module Recalled for Data Loss and Smoke Odor

    Terumo is recalling 579 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions involving data loss and smoke odor.

    Product
    Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2233-2012·2012-08-29

    Terumo Interface Module for CDl System 500 Recalled for Malfunctions

    Terumo is recalling Interface Modules for the CDl System 500 due to reported malfunctions involving loss of data transfer and smoke odor.

    Product
    Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2012·2012-08-29

    Terumo Advanced Perfusion System 1 Serial Interface Module Recall

    Terumo is recalling 34 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions and smoke odor.

    Product
    Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2012·2012-08-29

    Terumo Interface Module Recall for Data Transfer Malfunctions

    Terumo is recalling 232 interface modules for the CDl System 100/101 due to reported data transfer malfunctions and smoke odors.

    Product
    Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2218-2012·2012-08-22

    Terumo Sarns System 8000 Base Recalled for Incorrect Amperage Labeling

    Terumo is recalling three Sarns System 8000 bases because they were distributed with incorrect amperage ratings on the nameplate labels.

    Product
    System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical profe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2178-2012·2012-08-15

    Terumo Advanced Perfusion System 1 recalled for module malfunctions

    Terumo is recalling 649 Advanced Perfusion System 1 units worldwide due to faulty components in the Occluder and Air Bubble Detection modules.

    Product
    System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the oper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2012·2012-08-15

    Terumo Advanced Perfusion System 1 Recall for Module Malfunctions

    Terumo is recalling 992 Advanced Perfusion System 1 units due to faulty components in the Occluder and Air Bubble Detection modules.

    Product
    System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the oper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2055-2012·2012-08-01

    Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure

    Terumo CVS is recalling 992 Advanced Perfusion System 1 units due to drive motor failures that trigger alarms. The potential hazards depend on the specific medical application.

    Product
    System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2012·2012-08-01

    Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure

    Terumo CVS is recalling 640 Advanced Perfusion System 1 units worldwide due to drive motor failures in the Sarns Centrifugal System.

    Product
    System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2012·2012-07-25

    Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions

    Terumo is recalling 81 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2012·2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Network Communication Failures

    Terumo is recalling 648 Advanced Perfusion System 1 units due to reports of communications or power failures in the system network.

    Product
    Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2012·2012-07-25

    Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions

    Terumo is recalling 310 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by
    Category
    Medical Device
    Distribution
    Distributed nationwide