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.

26–50 of 204

  • ModerateFDA (Devices)·Z-0966-2019·2019-03-06

    Terumo Cardiovascular Procedure Kit Recalled for Undeclared Natural Rubber Latex

    Terumo Cardiovascular Systems Corporation is recalling 12 packs of Cardiovascular Procedure Kits because the presence of natural rubber latex is not declared on the label.

    Product
    Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0227-2019·2018-10-31

    Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System

    Terumo is recalling 135 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System because one energy platform is not compatible with the device.

    Product
    VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2019·2018-10-24

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Recall

    Terumo is recalling 152 Advanced Perfusion System 1 Electronic Patient Gas Systems because the service manual was not updated for software version 1.30.

    Product
    Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3242-2018·2018-10-03

    Terumo Advanced Perfusion System Recalled for Potential Electrical Short

    Terumo is recalling 47 Advanced Perfusion System units because improperly torqued screws may cause an electrical short.

    Product
    Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3243-2018·2018-10-03

    Terumo Advanced Perfusion System Power Manager Board Recall

    Terumo is recalling 10 Advanced Perfusion System units due to improperly torqued screws on the Power Manager Board, which may cause electrical shorts.

    Product
    Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2751-2018·2018-08-22

    Terumo CDI System 500 Monitor Recalled for H/Sat Module Self-Test Failure

    Terumo is recalling 128 CDI System 500 monitors because a subset of devices fail the automated H/Sat Color Chip Test. This failure disables the H/Sat module but does not cause device inaccuracy.

    Product
    Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2750-2018·2018-08-22

    Terumo CDI Blood Parameter Monitoring System 500 H/SAT Recalled for Self-Test Failures

    Terumo is recalling 128 CDI Blood Parameter Monitoring System 500 H/SAT units because a hybrid intensity shift causes the automated Color Chip Test to fail, disabling the H/Sat module.

    Product
    CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and tempera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2018·2018-05-02

    Terumo Flowmeter Module Recalled for Inaccurate Flow Readings

    Terumo Cardiovascular Systems Corporation is recalling seven Flowmeter Modules for the Advanced Perfusion System 1 due to inaccurate flow readings that may be difficult to detect.

    Product
    Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1417-2018·2018-04-25

    Terumo Sarns TCM Recall for Updated Cooler-Heater Cleaning Instructions

    Terumo is recalling Sarns TCM devices to update cleaning instructions for the cooler-heater component.

    Product
    Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1416-2018·2018-04-25

    Terumo HX2 Temperature Management System Recall for Updated Cleaning Instructions

    Terumo is recalling HX2 Temperature Management Systems to update cooler-heater cleaning instructions. The recall affects 2,393 units distributed worldwide.

    Product
    Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2018·2018-04-25

    Terumo Sarns TCM II Recall for Updated Cleaning Instructions

    Terumo is recalling Sarns TCM II devices to update cleaning instructions. The recall covers 2,393 units distributed worldwide.

    Product
    Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2018·2017-12-27

    Terumo Overpressure Safety Valve Recalled Due to No Flow Reports

    Terumo CVS is recalling 297,222 Overpressure Safety Valves worldwide after receiving reports of no flow through the device.

    Product
    TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0257-2018·2017-12-27

    Terumo Overpressure Safety Valve Recall Due to No Flow Reports

    Terumo CVS is recalling custom surgical kits containing Overpressure Safety Valves due to reports of no flow through the valve.

    Product
    Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1459-2017·2017-03-22

    Terumo Level Sensor Gel Pads Recalled for Non-Compliant Labeling

    Terumo is voluntarily recalling Level Sensor II Gel Pads because the expiration date format may not be recognizable to all users.

    Product
    Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1458-2017·2017-03-22

    Terumo Level Sensor II Pads Recalled for Non-Compliant Expiration Date Labeling

    Terumo Cardiovascular Systems Corporation is voluntarily recalling Level Sensor II Pads because the expiration date format may not be recognizable to all users.

    Product
    Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2017·2017-03-01

    Terumo Sarns Centrifugal Pump Recalled for Housing Cracks and Leaks

    Terumo is recalling Sarns Centrifugal Pumps because cracks in the housing can cause fluid leaks during cardiac procedures. No patient injuries have been reported.

    Product
    The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Pr
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1201-2017·2017-02-22

    Terumo Recalls Hercules 360 Universal Stabilizing Arms Due to Pin Separation

    Terumo CVS is recalling Hercules 360 Universal Stabilizing Arms because pins may come loose and fall into the surgical site.

    Product
    Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0001-2017·2016-10-12

    Terumo CDI H/S Cuvette Recall Due to Connection Error

    Terumo is recalling CDI H/S Cuvettes because they may fail to connect to the probe, causing the monitor to display an error and preventing blood parameter display.

    Product
    CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2207-2016·2016-07-27

    Terumo HX2 Temperature Management Systems Recalled Due to Sanitizer Availability

    Terumo CVS is voluntarily recalling HX2 Temperature Management Systems because the Interchlor sanitizer required for cleaning is no longer available.

    Product
    HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system cons
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-2210-2016·2016-07-27

    Terumo Sarns Dual Cooler-Heater Recalled Due to Missing Sanitizer

    Terumo CVS is voluntarily recalling Sarns Dual Cooler-Heater devices because the distributor no longer sells the Inter chlor sanitizer required for cleaning.

    Product
    Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero he
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-2208-2016·2016-07-27

    Terumo Recalls Sarns Temperature Control Units Due to Sanitizer Discontinuation

    Terumo CVS is voluntarily recalling Sarns TCM units because the Interchlor sanitizer referenced in cleaning instructions is no longer sold by the distributor.

    Product
    Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for card
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-2209-2016·2016-07-27

    Terumo Recalls Sarns TCM II Heater-Cooler Units Due to Sanitizer Discontinuation

    Terumo CVS is voluntarily recalling Sarns TCM II heater-cooler units because the Interchlor sanitizer referenced in cleaning instructions is no longer available.

    Product
    Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice su
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1250-2016·2016-04-06

    Terumo Recalls CDI Blood Parameter Monitoring System 500 for Temperature Errors

    Terumo is recalling 222 CDI Blood Parameter Monitoring System 500 devices because a faulty thermistor may cause inaccurate temperature and analyte readings.

    Product
    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hemato
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2742-2015·2015-09-16

    Terumo CDI 500 Blood Parameter Monitoring System Recalled for Inaccurate Readings

    Terumo is recalling 4,638 CDI 500 Blood Parameter Monitoring Systems worldwide due to inaccurate readings of vital blood parameters following a software upgrade to version 1.69.

    Product
    CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide