FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
- Recall number
- Z-0923-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
- Status
- Terminated
- Initiated
- 2004-04-01
- Posted
- 2007-06-30
- Terminated
- 2008-06-11
- Reason
- A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease.
- Root cause
- Other
- Action
- The firm is visiting consignees and making corrections as complaints are received. These corrections, to date, have been made between 04/04 and 09/06. The firm will correct other units as complaints are received and issued a Device Correction Letter dated 6/6 /07 notifying all users of the problem and appropriate responses should it occur.
- Quantity
- 525 total for both models
- Distribution
- Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.
- Lot, serial or model codes
- Serial numbers 0031 through 0324 are potentially affected by the problem. Serial numbers 0092, 0128, 0152, 0223, 0226, 0237, 0246, 0260 and 0296 have been corrected.
- 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