Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Air Bubble Detection Module, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802110. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1 Air Bubble Detection Module, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802110. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
Serial number 0727.
Products Sold
Serial number 0727.
Terumo Cardiovascular Systems Corporation is recalling Terumo Advanced Perfusion System 1 Air Bubble Detection Module, Terumo Cardiovascular Systems, Ann A due to The system may malfunction due to t-filter corrosion on an internal circuit board.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The system may malfunction due to t-filter corrosion on an internal circuit board.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026