The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V Product Usage: The Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion System 8000 . Five(5)of twelve(12) cables from Terumo Japan, which were in product development, were given to a US customer.

Terumo sent an URGENT MEDICAL DEVICE CORRECTION: Recall Notification dated November 8, 2011 to all affected customers. The letter described the reason for the recall, known/potential hazards and request immediate location and correction of product. The letter instructs customers to stop using the modified cables and return to Terumo for replacement and destruction. Customers were asked to complete the attached response form and fax to the number indicated on the form. All affected customers will be receiving a safety advisory to advise them that Terumo do not recommend the alternative configuration of a System 1 Base with an 8K Occluder. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818 or 1-800-292-6551 (fax).