Terumo Cardiovascular Group

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Progress Report

Terumo Cardiovascular Systems Announces Compliance Milestone:

The U.S. FDA Lifts Remaining Restrictions on Product at Ann Arbor Facility

An open letter to our customers:

June 10, 2016

 

Dear Valued Customer,

We have great news to share!

Terumo Cardiovascular Systems (Terumo CVS) received notice from the U.S. Food and Drug Administration (FDA) that it has successfully completed the second and final phase of its work plan to remediate all products manufactured or distributed from Terumo's Ann Arbor, Michigan manufacturing facility, including Terumo® Advanced Perfusion System 1. Read the press release.

This follows the February 2015 notification that the general Quality Systems and the CDI® Blood Parameter Monitoring System 500 hardware were in compliance with the FDA regulations.

As a result, all shipping restrictions imposed as a term of its 2011 consent decree are now lifted.

Terumo CVS agreed to the restrictions in 2011 as a condition of our consent decree with the FDA. Since then, we've worked relentlessly to fulfill our commitments to the terms of the decree.

Positioned for the Future

As a result of our Quality journey, we've made a tremendous investment in our Ann Arbor site and have designated it as a hardware center of excellence. We've demonstrated our ability to meet the FDA medical device manufacturing requirements in today's highly regulated environment. And, we've emerged a stronger, smarter, more agile and more compliant company — well positioned to meet regulatory requirements today and into the future.

Throughout this challenging period, we've remained committed to serving our customers and their patients in the CV OR.

Moving Forward

While we have continued to deliver many important technologies like oxygenators, circuits, and monitoring devices, we're looking forward to once again providing our customers our full range of perfusion products.

As always, our primary concerns remain patient safety and product quality. We will continue to invest in our processes, programs, and people to ensure that we remain a leader in the perfusion industry.

Our commitments to you:

  • We will continue to offer unique and innovative technologies for perfusionists and the CV OR.
  • We will return our business to a steady state — providing consistent and reliable product supply to our customers.
  • We will continue to provide industry-leading clinical education, field service and support. We see these as foundations of our relationships with our customers.
  • We will maintain our focus on product and process quality, reliability and compliance.
  • And most importantly — we will continue to work with you as a team to help save lives.

Sincerely,

Mark Sutter
President and CEO
Terumo Cardiovascular Systems Corporation