Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arteria Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arteria
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: 882298 882299 882300 882752 882753 882794 882795 882796 882797 882798 882799 885547 885548 885549 885550 885553
Terumo Cardiovascular Systems Corporation is recalling Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use f due to These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associate. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
Recommended Action
Per FDA guidance
Terumo began notifying customers via telephone to schedule the repairs on 1/2/20. Urgent Medical Device Correction notification letters dated 1/6/20 were sent to customers.
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