FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. 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-0206-2009
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. 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
- 2008-07-18
- Posted
- 2008-10-31
- Terminated
- 2009-07-07
- Reason
- Local pump controls including start/stop button, select button and manual button may not function.
- Root cause
- Component design/selection
- Action
- Consignees were notified by recall letter dated 7/18/08 and were provided with revised operating instructions telling them to revert to the central control module should these problems occur.
- Quantity
- 300
- Distribution
- Nationwide, Australia, Belgium, Canada, 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.
- Lot, serial or model codes
- Serial numbers 0006 through 0066, 0100 through 0322 and 1001 through 1017.
- 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