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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS 1

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 Class 2 Recall
Terumo APS 1
see related information
Date Posted December 11, 2008
Recall Status1 Terminated on July 07, 2009
Recall Number Z-0355-2009
Recall Event ID 44839
Premarket Notification
510(K) Number
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump; Model 801041). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Code Information Serial numbers 0030, 0032 through 0587, 0700 through 1936, 1947 through 1951 and 2000 through 2799.
Recalling Firm/
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor, Michigan 48103
Manufacturer Reason
for Recall
Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Consignees were notified of the problem via recall letter dated 7/18/08. The firm began conducting field upgrades on the roller pumps in 07/08. For questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818.
Quantity in Commerce 2,599
Distribution Worldwide Distribution including USA and countries of Australia, Belgium. Canada, Columbia, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.