Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1978-2013·Announced 2013-08-21

Terumo Advanced Perfusion System 1 Recall for Pressure Alarm Issue

Terumo is recalling 1,657 Advanced Perfusion System 1 units to update manuals and address a false high-pressure alarm that can stop the pump.

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 source text describes a functional issue (false alarm) with a provided workaround and does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary action.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 1,657 units of the 220/240V AC Advanced Perfusion System 1. The recall is being conducted to update the Operators Manual with specific instructions to respond to a known condition and to issue a labeling addendum for current users.

The issue involves a false high-pressure alarm condition that displays a "999" pressure reading and results in the pump stopping. The source text notes that this pressure display can be cleared and the pump restarted by disconnecting the pressure transducer from the system.

The affected devices were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Canada, Japan, and Mexico. Users should refer to the updated manual and labeling addendum provided by the recalling firm for specific instructions on managing this condition.

The recalled product

Product: 220/240V AC, Advanced Perfusion System 1 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 used by a qualified…
Manufacturer: Terumo Cardiovascular Systems Corporation
Category: Medical Device — Cardiovascular / Perfusion
Hazard: false-alarm
equipment-malfunction
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.

The notice also names 43 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 →

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · false alarm