The Recall Desk
ModerateFDA (Devices)·Z-1973-2013·Announced 2013-08-21

Terumo Advanced Perfusion System 1 Recalled for False Pump Service Error

Terumo is recalling Advanced Perfusion System 1 units because user-induced movement may trigger a false 'Service Pump' error message, potentially causing unnecessary service delays.

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. The hazard involves a software error message that may be misinterpreted, leading to potential delays in equipment availability, but the source text does not report any injuries, illnesses, or deaths.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the Terumo Advanced Perfusion System 1 (APS1) 100/120V AC. The recall involves 1,657 units distributed worldwide, including across the United States and various international markets.

The recall was initiated because the APS1 may display a 'Service Pump' error message if the centrifugal pump is moved by the user while not activated. The system is designed to identify this movement, but the resulting error message may be misinterpreted by users as an indication that the pump requires mechanical service. This could lead to unnecessary service interruptions or delays in the use of the equipment.

The product is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Users should be aware that a 'Service Pump' message appearing immediately after moving the pump while it is not activated is likely due to the movement rather than a mechanical fault. Users should consult their equipment manuals or contact Terumo for specific guidance on interpreting these messages.

The recalled product

Product
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V 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 only when use
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: 801763 Description: 100/120V 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 →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · software error

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