Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 6 inch diameter Roller Pump; Model 801041. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1; 6 inch diameter Roller Pump; Model 801041.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0030, 0033, 0034, 0036, 0037, 0038, 0041, 0042, 0043, 0045, 0046, 0047, 0048, 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098 through 0119, 0122, 0124, 0125, 0127 through 0163, 0165, 0166, 0167, 0168, 0169, 0170, 0172, 0173, 0175, 0177, 0179, 0181, 0182 through 0231, 0233 through 0278, 0280 through 0481, 0483 through 0587, 0700 through 0753, 0757 through 0766, 0768, 0769, 0771 through 0787, 0789 through 0793, 0795 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1028, 1030 through 1051, 1053 through 1075, 1079 through 1268, 1270 through 1936, 1947 through 1951, 2000 through 2029, 2033, 2034, 2036 through 2038, 2042 through 2182 and 2186 through 2205.
Products Sold
Serial numbers 0030, 0033, 0034, 0036, 0037, 0038, 0041, 0042, 0043, 0045, 0046, 0047, 0048, 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098 through 0119, 0122, 0124, 0125, 0127 through 0163, 0165, 0166, 0167, 0168, 0169, 0170, 0172, 0173, 0175, 0177, 0179, 0181, 0182 through 0231, 0233 through 0278, 0280 through 0481, 0483 through 0587, 0700 through 0753, 0757 through 0766, 0768, 0769, 0771 through 0787, 0789 through 0793, 0795 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1028, 1030 through 1051, 1053 through 1075, 1079 through 1268, 1270 through 1936, 1947 through 1951, 2000 through 2029, 2033, 2034, 2036 through 2038, 2042 through 2182 and 2186 through 2205.
Terumo Cardiovascular Systems Corp is recalling Terumo Advanced Perfusion System 1; 6 inch diameter Roller Pump; Model 801041. due to The large roller pump may experience false "overspeed' error message when starting rotation, which will prevent the pump from operating; until the con. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The large roller pump may experience false "overspeed' error message when starting rotation, which will prevent the pump from operating; until the condition is cleared by power cycling the roller pump.
Recommended Action
Per FDA guidance
Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.
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