Terumo Advanced Perfusion System 1 Recalled for Total Loss of Functionality
Terumo is recalling 1,647 Advanced Perfusion System 1 units because they may shut down completely, stopping pumps and failing to activate battery backup.
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 critical medical device failure (total loss of power and pump function) during life-support procedures, which meets the criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 1,647 units of the Advanced Perfusion System 1 (APS) due to reports of total loss of functionality. The affected devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall was initiated after users reported that some System 1 units went blank and shut down with no sign of power. In these instances, the battery backup did not initiate, resulting in all pumps stopping and a lack of safety system functionality. The affected units are identified by catalog number 801763 and all serial numbers.
The recall covers units distributed worldwide, including nationwide distribution in the United States across numerous states. Users of these devices should contact Terumo Cardiovascular Systems Corporation for further instructions on how to address the issue.
The recalled product
- Product
- 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qua
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 1,647
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)
- Catalog number: 801763 and all serial numbers
Distribution
Part of a larger recall action
This product is one of 2 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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