FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 801041.
- Recall number
- Z-0601-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 801041.
- Status
- Terminated
- Initiated
- 2004-09-01
- Posted
- 2007-06-30
- Terminated
- 2009-07-07
- Reason
- The internal ribbon cable may loosen from the roller pump display board, resulting in loss of local control and/or local display.
- Root cause
- Other
- Action
- The firm corrected units in the field or brought them back for evaluation and repair as complaints were received between 9/04 and 4/06. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.
- Quantity
- 1,484 of both models
- Distribution
- Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Mexico, Malaysia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.
- Lot, serial or model codes
- Serial numbers 0030 through 0998 may be affected. Serial numbers 0052, 0418, 0559, 0745 and 0767 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