Terumo Advanced Perfusion System 1 Roller Pump Recall for Shaft Failure
Terumo is recalling 106 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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used during surgery where a mechanical failure could lead to a pump stop, representing a risk of harm even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 106 units of the Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. 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 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 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.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the recall notice. Users should stop using the affected devices and contact Terumo Cardiovascular Systems Corporation for further instructions on replacement or repair.
The recalled product
- Product
- Terumo 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 arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a quali
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 106
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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