FDA Medical Device Recalls (openFDA)
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 number
- Z-0670-2009
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- 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.
- Status
- Terminated
- Initiated
- 2007-11-20
- Posted
- 2009-01-29
- Terminated
- 2009-08-06
- Reason
- The system may malfunction due to t-filter corrosion on an internal circuit board.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 1219 (total)
- Distribution
- 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.
- Lot, serial or model codes
- Serial number 0727.
- 510(k) numbers
- ["K022947"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28