Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
Serial numbers 0028 through 0111, 0113 through 0527, 0700 through 1528, 1539 through 1579, 2000 through 2392 and 2395 through 2466.
Products Sold
Serial numbers 0028 through 0111, 0113 through 0527, 0700 through 1528, 1539 through 1579, 2000 through 2392 and 2395 through 2466.
Terumo Cardiovascular Systems Corporation is recalling Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040). Extracorporeal circ due to Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.
Recommended Action
Per FDA guidance
Consignees were notified of the problem via recall letter dated 7/18/08. The firm began conducting field upgrades on the roller pumps in 07/08. For questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818.
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