Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1969-2013·Announced 2013-08-21

Terumo Advanced Perfusion System 1 Recall for Incomplete Operator Manual

Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump reactions during specific alarm conditions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 a documentation/labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity score involving minor labeling errors or voluntary precautionary measures.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 1,657 units of the Terumo Advanced Perfusion System 1 (Catalog number: 801764). 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 adjusts 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 countries in Asia, Europe, and the Middle East.

No specific instructions for end-users are provided in the source text, as the issue is a documentation deficiency in the professional operator manual. The recall is classified as Class II by the FDA.

The recalled product

Product: Terumo¿ Advanced Perfusion System 1: 220/240V 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…
Manufacturer: Terumo Cardiovascular Systems Corporation
Category: Medical Device — Cardiovascular / Perfusion
Hazard: mis-labeling
documentation-error
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: 801764

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.

See all 2 products in this recall →

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · mis labeling