The Recall Desk
ModerateFDA (Devices)·Z-1974-2013·Announced 2013-08-21

Terumo Advanced Perfusion System 1 Recalled for False Service Pump Error Messages

Terumo is recalling 1,657 Advanced Perfusion System 1 units because user-induced motor movement can trigger a false 'Service Pump' error message, potentially misleading operators.

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, and the hazard involves a false error message that could lead to operational confusion but does not present a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 1,657 units of the Advanced Perfusion System 1 (APS1), specifically the 220/240V AC models. The recall is due to a software or operational issue where user-induced motor movement can cause the system to display a 'Service Pump' error message. This message is designed to identify movement, but it may be misinterpreted by users as an indication that the pump requires maintenance or repair, rather than a response to physical movement while the pump is not activated.

The affected devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. These systems are intended to be used only by qualified perfusionists experienced in operating Sarns or similar equipment. The recall covers units distributed worldwide, including all 50 US states, Washington DC, and numerous international locations such as Australia, Canada, Japan, and various countries in Europe, Asia, and South America.

Healthcare facilities and users should stop using the affected devices and contact Terumo Cardiovascular Systems Corporation for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that the use of the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiovascular / Perfusion
Hazard
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 (2)

  • Catalog Number or Part Number: 801764 Description: 220/240V AC
  • Advanced Perfusion System 1

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

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 →

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Same manufacturer · Terumo Cardiovascular Systems Corporation

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