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.

151–175 of 204

  • HighFDA (Devices)·Z-2044-2012·2012-07-25

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

    Terumo Cardiovascular Systems is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 8000 base, 4 pump 115V. 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 qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2012·2012-07-25

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

    Terumo is recalling 26 Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 8000 base, 4 pump 100V. 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 qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2012·2012-07-25

    Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions

    Terumo Cardiovascular Systems is recalling 286 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusioni
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2012·2012-07-25

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

    Terumo is recalling Sarns Modular Perfusion System 8000 units 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 115V. The Sarns Modular Perfusion Systern 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 q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2052-2012·2012-07-25

    Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions

    Terumo is recalling 31 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2012·2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Power Malfunction

    Terumo is recalling 992 Advanced Perfusion System 1 units due to a power loss error message that may affect system stability during medical procedures.

    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 wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2021-2012·2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Power Fluctuation Errors

    Terumo is recalling 648 Advanced Perfusion System 1 units due to a Red X error indicating loss or fluctuation of internal power on one side of the base.

    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 wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2012·2012-07-25

    Terumo Advanced Perfusion System 1 recalled for air bubble detection malfunctions

    Terumo is recalling 648 Advanced Perfusion System 1 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and oversensitivity.

    Product
    Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2012·2012-07-25

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

    Terumo is recalling 461 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, 4 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
  • HighFDA (Devices)·Z-2009-2012·2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Network Power Failures

    Terumo is recalling 992 Advanced Perfusion System 1 units worldwide due to reports of communications and power failures in the system network.

    Product
    Terumo Advanced Perfusion System 1 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2012·2012-07-25

    Terumo Advanced Perfusion System Recalled for Air Bubble Detection Malfunctions

    Terumo is recalling 992 Advanced Perfusion System I units worldwide due to reported malfunctions in the Air Bubble Detection System, including oversensitivity and false alarms.

    Product
    Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2012·2012-07-25

    Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions

    Terumo is recalling 484 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 648 units of the Advanced Perfusion System 1 due to roller pump malfunctions that may require replacement with back-up equipment during procedures.

    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-1958-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Central Control Module Recall

    Terumo is recalling 648 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.

    Product
    Central Control Module for 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 by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues

    Terumo is recalling approximately 632 System 1 Base units because the backup battery depletes faster than expected, potentially causing unexpected system shutdowns.

    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
    41 states
  • HighFDA (Devices)·Z-1968-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions

    Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump occlusion malfunctions that could prevent pump use.

    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-1970-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump malfunctions that could require backup equipment during surgery.

    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-1965-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues

    Terumo is recalling approximately 993 Advanced Perfusion System 1 units because the battery may deplete faster than expected during shutdown, potentially causing unexpected system failure.

    Product
    System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional wh
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1957-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Central Control Module Recall

    Terumo is recalling 992 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.

    Product
    Central Control Module for System 1: 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2012·2012-07-18

    Terumo Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions

    Terumo CVS is recalling 648 Advanced Perfusion System 1 units due to roller pump occlusion malfunctions that could prevent pump use during surgery.

    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
  • ModerateFDA (Devices)·Z-1963-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Gas System Recall

    Terumo is recalling 648 Advanced Perfusion System 1 units because users reported difficulty adjusting the gas system flow control knob.

    Product
    Terumo Advanced Perfusion System 1 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1962-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Gas System Recall for Flow Control Issues

    Terumo is recalling 1,095 units of the Advanced Perfusion System 1 Electronic O2 Blender/Analyzer due to reported difficulty adjusting the local flow control knob.

    Product
    Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Gas Control Recall

    Terumo is recalling 992 Advanced Perfusion System 1 units due to reported difficulty adjusting the gas flow control knob.

    Product
    Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. 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
  • SevereFDA (Devices)·Z-1893-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance was found on the inner surface of some cannula tips that could dislodge.

    Product
    CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1884-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some cannula tips that can be dislodged.

    Product
    X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during c
    Category
    Medical Device
    Distribution
    Distributed nationwide