Alleged quality control issues have prompted the U.S. Food and Drug Administration to bar Terumo Cardiovascular Systems from selling heart-lung bypass systems and related equipment under certain conditions and to make the company hand over nearly $35 million in back profits.

The FDA said Tuesday it signed a consent decree of a permanent injunction on March 17 with two executives from the Ann Arbor, Mich.-based company. Terumo, a subsidiary of Tokyo-based Terumo Corp., must pay the feds back profits from devices sold to the government.

The FDA said the Justice Department will soon file the decree with the U.S. District Court for the Eastern District of Michigan.
The penalties stem from quality control violations reported by FDA inspectors at the company's Ann Arbor manufacturing plant during visits last year. The company had twice received warning letters, in 2004 and 2006, according to reports.

On its website, Terumo said products made at its Ashland, Mass. and Elkton, Md. plants, such as shunt sensors, oxygenator, filters, cuvettes and others, are unaffected.

According to Terumo, the following two products cannot be sold:

· CDI 101 Hematocrit/Oxygenation Saturation Monitoring System
· TenderFlow Pediatric Arterial Cannula

Terumo said the following were restricted and can only be sold if the buyer signs a Certificate of Medical Necessity:

· Terumo Advanced Perfusion System 1
· Sarns Modular Perfusion System 8000
· Sarns Centrifugal System
· Sarns Centrifugal System
· CDI 500 Blood Parameter Monitoring System
· Sarns Sternal Saw II System and Replacement Blades
· TLink Data Management System
· Cannulae for Cardiopulmonary Bypass
· Cannulae for Cardioplegia Delivery
· Vents, Suckers, Dilators, Connectors and Reducers

No devices were recalled, the FDA said, and Terumo can still service existing equipment.

The company said it was working to resolve the issues.

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