Class 2 Device Recall

• Date Initiated by Firm: March 17, 2005
• Date Posted: March 31, 2005
• Recall Status: Terminated on September 16, 2005
• Recall Number: Z-0666-05
• Recall Event ID: 31489
• 510(K)Number: K022947
• Product Classification: Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040.
• Code Information: Serial numbers 0028 through 0527 and 0700 through 0874.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: 800-521-2818
• Manufacturer Reason for Recall: The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.
• FDA Determined Cause: Other
• Action: Recall letters dated 3/17/05 were sent to customers advising them of the problem, the temporary fix, and that software will be upgraded.
• Distribution: Nationwide, Australia, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malasia, Mexico, Pakistan, South Africa, South Korea, Taiwan, Thailand and United Arab Emirates.
• 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