—#64434

Product

Terumo Advanced Perfusion System 1 Temperature Monitoring Systems, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802114. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: Serial number 0637.

Why it was recalled

The system may malfunction due to t-filter corrosion on an internal circuit board.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

U.S. consignees were notified of the problem by letter on 11/16/07. International affiliates were informed via email on 11/21/07. Consignees were informed that Terumo would schedule appointments to install new pressure modules and reconfigure the systems beginning in Feb. 2008 or that parts would be shipped to consignees wishing to perform the work themselves. For additional information, contact Terumo CVS Customer Service at 1-800-521-2818.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.

Timeline

Recall initiated: 2007-11-20
Posted by FDA: 2009-01-29
Terminated: 2009-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64434. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.