Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0001 through 0599.
Products Sold
Serial numbers 0001 through 0599.
Terumo Cardiovascular Systems Corp is recalling Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040. due to The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.
Recommended Action
Per FDA guidance
Letters entitled Urgent Safety Alerts were sent to each customer on 10/16/03. Customers were made away of the problem and advised to develop a protocol for action, in case the problem occurred in their facility.
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