Terumo Advanced Perfusion System 1 Roller Pump Recall for Shaft Failure
Terumo is recalling 33 Advanced Perfusion System 1 Roller Pumps because the pump shafts may fail, potentially causing the pump to stop during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a critical medical device used during surgery, which poses a significant risk of harm if the pump fails.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 33 units of the Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall is due to a defect where the pump shafts may fail at the location of the thread where a locknut is installed. This failure is associated with an atypical noise caused by an unsecured shaft end contacting the rotating pulley. Prolonged use of the pump in this condition could lead to a pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
The affected units were distributed worldwide, including in the US states of Connecticut, Florida, Louisiana, Massachusetts, Michigan, New York, and Texas, as well as in Hong Kong, India, South Korea, and Taiwan. The recall is classified as Class II by the FDA. Users should identify affected units by checking the serial numbers listed in the official recall notice and contact Terumo for instructions on replacement or repair.
The recalled product
- Product
- 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 quali
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 33
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00886799000533
Distribution
Part of a larger recall action
This product is one of 4 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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