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Use of Cardiopulmonary Bypass Devices in ECMO

In accordance with FDA’s Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, which was issued on April 6, 2020, Terumo Cardiovascular is providing updates regarding our Cardiopulmonary Bypass Devices (see below for applicable devices).


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Product Servicing in the United States

Terumo Cardiovascular continues to conduct service activities for our customers throughout the COVID-19 pandemic. As the situation develops, COVID-19 is causing some challenges for our Field Service team including travel restrictions and hospital access restrictions in some regions.

Currently, we are experiencing limited impact to services, and we are pleased to report that many accounts are not affected. But we recognize that the situation is dynamic, and we want to proactively anticipate the potential for delays in service activities (including Preventative Maintenance) for your Terumo serviceable products.

Terumo is committed to protecting the health and safety of our associates. Our concern for health and safety extends to your team as well. If you have an upcoming service activity due — particularly if your facility is located in a region that is currently designated as a COVID-19 "hotspot" — we ask that you reach out to our Terumo Field Service team with any hospital entry requirements or restrictions. We will work with you to schedule an appointment time that is convenient, meets your hospital guidelines, and ensures the highest levels of safety.

If Terumo is not able to complete the required service activity or Preventative Maintenance by the required due date, Terumo Cardiovascular recommends that you do not use the device until it is properly maintained.

We thank you for your patience and for continuing to serve our communities during this extraordinary time. Please contact your Terumo representative or call Terumo Cardiovascular Customer Support at 800.521.2818 if you have any questions.

For support and information for international market, Click Here to find your local Terumo distributor or branch.

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