Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump, Terumo Cardiovascular Systems, Ann Arbor, MI; Model 801041. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
FDA Recall Z-0674-2009 · Posted 2009-01-29
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2007-11-20
Date Terminated2009-08-06
Product Quantity1219 (total)
Reason for Recall
The system may malfunction due to t-filter corrosion on an internal circuit board.
Firm Action
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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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