Class 2 Device Recall Terumo Advanced Perfusion System 1

• Date Initiated by Firm: July 18, 2008
• Date Posted: November 25, 2008
• Recall Status: Terminated on July 07, 2009
• Recall Number: Z-0310-2009
• Recall Event ID: 46312
• 510(K)Number: K022947
• Product Classification: Cardiopulmonary Bypass Heart-Lung Machine Console - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.; ; The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns(TM) or similar equipment.
• Code Information: Serial numbers 0030, 0032 through 0587, 0700 through 1527, 1529, 1531 through 1533, 1563 through 1569, 1572, 1575, 1577 through 1581, 1584 through 1587, 1607, 2230 through 2235, 2239 through 2242, 2581 through 2583 and 2587 through 2594.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Rd; Ann Arbor MI 48103
• For Additional Information Contact: 800-521-2818
• Manufacturer Reason for Recall: The pumps may fail to power up or experience unplanned pump stops.
• FDA Determined Cause: Process control
• Action: Consignees were advised of the problem via an Urgent Medical Device Correction: Safety Advisory letter dated 7/18/08 and each consignee was contacted by phone to assure receipt. The letter noted that the firm was not recommending that customers stop using the product. If customers found the risk unacceptable they were to contact Technical Service, 1-800-521-2818. Customers were to review the notice, assure all users were aware of the notice, and confirm receipt by completing the attached Customer Response Form and faxing it to the number indicated on the form.
• Quantity in Commerce: 1429
• Distribution: Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.