Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: 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 proffes
Check against the official notice below — it lists the full affected range.
Terumo Cardiovascular Systems Corporation has recalled 33 Terumo Advanced Perfusion System 1 Roller Pumps (Catalog Number 816570) designed for use up to 6 hours in extracorporeal circulation. The recalled pumps were assembled with defective pump shafts that may fail at the threaded location where a locknut is installed. This failure causes an unusual noise during operation and occurs when an unsecured shaft end contacts the pump's rotating pulley.
If a recalled pump continues to operate while defective, the pulley can loosen and the drive belt can sustain damage, potentially causing the pump to stop functioning and lose the ability to create necessary pump flow. The recall affects 33 units with specific serial numbers (6860-6865, 6876-6877, 6885, 6910-6953) and includes devices distributed nationwide in Connecticut, Florida, Louisiana, Massachusetts, Michigan, New York, and Texas, as well as internationally in Hong Kong, India, South Korea, and Taiwan. The source does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan. Quantity: 33 Lot/code info: UDI: 00886799000533; Serial Numbers: 6860 6861 6862 6863 6864 6865 6876 6877 6885 6910 6911 6912 6913 6934 6935 6936 6937 6938 6939 6940 6941 6942 6943 6944 6945 6946 6947 6948 6949 6950 6951 6952 6953
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.