Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0028 through 0527 and 0700 through 0874.
Products Sold
Serial numbers 0028 through 0527 and 0700 through 0874.
Terumo Cardiovascular Systems Corp is recalling Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040. due to The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM whi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.
Recommended Action
Per FDA guidance
Recall letters dated 3/17/05 were sent to customers advising them of the problem, the temporary fix, and that software will be upgraded.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026