Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 801040. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 801040.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0031 through 1188.
Products Sold
Serial numbers 0031 through 1188.
Terumo Cardiovascular Systems Corp is recalling Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 801040. due to The pump may stop during the autodose delivery without completion of the dose delivery to the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The pump may stop during the autodose delivery without completion of the dose delivery to the patient.
Recommended Action
Per FDA guidance
Service technicians were notified on 9/30/05 to upgrade the software on these units by March 31, 2006 as follows: pump software to version 1.20, power manager software to version 1.20 and monitor software to version 2.2.1. U.S. software has all been upgraded and international upgrades are ongoing as of 7/7/06.
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