FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1 Flow Module; Catalog number 802018.
- Recall number
- Z-0333-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Advanced Perfusion System 1 Flow Module; Catalog number 802018.
- Status
- Terminated
- Initiated
- 2004-10-12
- Posted
- 2006-12-30
- Terminated
- 2007-02-01
- Reason
- Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Root cause
- Other
- Action
- U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.
- Quantity
- 4740 for all affected products
- Distribution
- Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
- Lot, serial or model codes
- Serial numbers 00017, 00020, 00023 through 00026, 00029 through 00031, 00033, 00034, 00036 through 00048, 00051 through 00055, 00057 through 00078, 00080 through 00120, 00122 through 00134, 00136, 00138 through 00155, 00158 through 00169, 00171 through 00210, 00212 through 00243 and 00248.
- 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