Terumo Advanced Perfusion System 1 recallZ-1108-2020 · Terumo Cardiovascular Systems Corporation · initiated Jan 10, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1108-2020
- Status
- Terminated
- Initiated by the company
- Jan 10, 2020
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 33
- Product code
- DTQ
- FDA submissions
- K172220
- 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.
Product description
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 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 arterial blood pumping, cardioplegia delivery, suction, and venting.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Terumo® Advanced Perfusion System 1 801040Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 84663).
- Z-1109-2020 · TerminatedTerumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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