Terumo Advanced Perfusion System 1 Recalled for Power Loss
Terumo is recalling Advanced Perfusion System 1 units that may lose power and shut down during use, causing pumps to stop.
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 medical device used for cardiopulmonary bypass where a total loss of functionality and pump stoppage poses a significant risk of serious injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 1,647 units of the 220/240V AC Advanced Perfusion System Platform (APS) System 1. The recall involves catalog number 801764 and all serial numbers. The devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall was initiated after reports that some units experienced a total loss of functionality. Users reported that the units went blank and shut down with no sign of power, and the battery backup did not initiate. This failure results in all pumps stopping with no safety system functionality.
The affected units were distributed worldwide, including nationwide distribution in the United States. Users should contact Terumo Cardiovascular Systems Corporation for further instructions on how to proceed with the recall.
The recalled product
- Product
- 220/240V 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
- Hazard
- 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: 801764 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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