Terumo Advanced Perfusion System 1 Recalled for Incomplete Operator Manual Instructions
Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump behavior during specific alarm conditions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to incomplete labeling in the operator manual without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 1,657 units of the Terumo Advanced Perfusion System 1 (Catalog number: 801763). The recall is due to a labeling deficiency in the operator manual. The manual does not fully describe the sequence of expected events when a user is adjusting the centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with a configuration for a pump coast response.
The affected devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The units were distributed worldwide, including the United States, Australia, Canada, and various other countries. The recall is classified as Class II by the FDA.
Users should contact Terumo Cardiovascular Systems Corporation for further instructions on how to proceed with the recall and to obtain updated documentation.
The recalled product
- Product
- Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 1,657
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
Distribution
Distributed nationwide across the United States.
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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