Terumo Cardiovascular Group

About Terumo CVS' Consent Decree

Status of Terumo CVS Products

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Terumo Cardiovascular Systems (Terumo CVS) has agreed to terms of a consent decree with the U.S. Food and Drug Administration (FDA) to resolve FDA's concerns with the Quality System at the company's Ann Arbor, Michigan facility.

Under the terms of the consent decree, Terumo CVS agrees to restricting the distribution of products manufactured at the Ann Arbor facility while it completes the terms outlined in the decree. Products produced at other Terumo CVS manufacturing facilities are not subject to any restrictions. Products produced at other Terumo CVS manufacturing facilities (map) are not subject to any restrictions.

This document defines the status of all Terumo CVS product1 during the time it completes the terms of the consent decree:

The consent decree does not require Terumo CVS to recall, remove, or perform any corrective actions on the products currently in clinical use or in inventory at customer facilities.

I. Restricted Products

Under the terms of the consent decree, Terumo CVS cannot provide the following products. The Notification Guide provides a list of alternative products for users' consideration while these products are unavailable.

  • CDI™ 101 Hematocrit/Oxygenation Saturation Monitoring System NOTE: The disposable hematocrit/oxygen saturation cuvettes are available for use with existing CDI 101 systems or other CDI monitoring systems.
  • TenderFlow™ Pediatric Arterial Cannula

II. Products Available with Certificate of Medical Necessity

Terumo CVS may continue to distribute and service the following products for existing users that sign a Certificate of Medical Necessity (appended to the Users Notification Guide):

Heart-lung Machines:

  • Terumo® Advanced Perfusion System 1
  • Sarns™ Modular Perfusion System 8000

Centrifugal System:

  • Sarns™ Centrifugal System
    Note: The Sarns™ Disposable Centrifugal Pump is available without sales restriction.

Cooling and Heating Devices:

  • HX2™ Temperature Management System
  • Sarns™ TCM II Cooling and Heating System

Interoperative Monitoring Systems:

  • CDI™ 500 Blood Parameter Monitoring System
    Note: Disposable shunt sensors and hematocrit/oxygen saturation cuvettes are available without sales restriction.

Sternal Saw:

  • Sarns™ Sternal Saw II System and Replacement Blades

Data Management System:

  • TLink™ Data Management System Note: The TLink™ system is available as an accessory to any Terumo CVS heart-lung machine.

Cannulae:

  • Cannulae for Cardiopulmonary Bypass
  • Cannulae for Cardioplegia Delivery
  • Vents, Suckers, Dilators, Connectors and Reducers
    Note: TenderFlow™ Pediatric Arterial Cannulae are not available.

III. Products Available without Restriction

Products manufactured by Terumo CVS at its other facilities, products that Terumo CVS distributes for other manufacturers, and any product manufactured by another Terumo company are exempt from any restrictions under the terms of the consent decree:

Products Manufactured by Terumo CVS

Oxygenation Systems and Accessories:

  • CAPIOX® SX Oxygenators
  • CAPIOX® RX Oxygenators
  • CAPIOX® FX Oxygenators
  • ROCSafe™ Hybrid Perfusion System

Custom Tubing Packs Note: Tubing Packs that contain Terumo Cannulae are available with restrictions.

Disposable Centrifugal Pumps:

  • Sarns™ Disposable Centrifugal Pump
  • CAPIOX® Disposable Centrifugal Pump

Reservoirs:

  • CAPIOX® Flexible Venous Reservoirs
  • CAPIOX® Cardiotomy Reservoir

Myocardial Protection Products:

  • Sarns™ Cardioplegia Sets with Conducer Heat Exchanger and MP-4™ Monitoring Module
  • Sarns™ Cardioplegia Sets with PVC Coil and MP-4™ Monitoring Module
  • Sarns™ Cardioplegia Sets with Conducer Heat Exchanger and Bubble Trap
  • Sarns™ Cardioplegia Sets with PVC Coil and Bubble Trap
  • CAPIOX® CP50 Cardioplegia Set

Filters:

  • Terumo® AL6X Arterial Blood Line Filter
  • Terumo® AL8X Arterial Blood Line Filter
  • CAPIOX® Arterial Line Filters

Hemoconcentrators:

  • CAPIOX® Hemoconcentrators

Bubble Traps:

  • CAPIOX® Bubble Traps

Vessel Harvesting:

  • VirtuoSaph® Endoscopic Vein Harvesting System
  • VirtuoSaph® Plus Endoscopic Vessel Harvesting System
  • Terumo® Endoscope
  • Generator, Endoscopic Tower Components, Sterilization Trays

Products Terumo CVS distributes for other manufacturers

Continuous Autotransfusion System:

  • Fresenius C.A.T.S Continuous AutoTransfusion System

Platelet Therapy:

  • SmartPReP® 2 Platelet Concentrate System

Filters:

  • Pall Filters for use in Cardiopulmonary Bypass

Hemoconcentrators:

  • Minntech® Hemocor® HPH Hemoconcentrators

Products Manufactured by other Terumo Companies 

  • Terumo Medical Corporation
  • Terumo Interventional Systems, a business unit of Terumo Medical Corporation
  • Terumo Heart, Inc.
  • Vascutek Ltd.
  • MicroVention, Inc.
  • Harvest Technologies Corporation
  • Terumo BCT, Inc.
  1. "Products" refers to all components and accessories that are dedicated for use with the named product unless otherwise noted.