Agency classClass IIOur severity:High FDA (Devices)·Z-2177-2012·Announced 2012-08-15

Terumo Advanced Perfusion System 1 Recall for Module Malfunctions

Terumo is recalling 992 Advanced Perfusion System 1 units due to faulty components in the Occluder and Air Bubble Detection modules.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the device is used for critical life-support procedures (cardiopulmonary bypass). While no specific injuries are reported in the text, the risk of harm from malfunctioning perfusion equipment is significant, fitting the 'High' criteria for risk-of-harm products.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 992 units of the Terumo Advanced Perfusion System 1 base 100/120V. This medical device is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The affected units are distributed worldwide, including in the United States and numerous international markets.

The recall is being conducted due to malfunctions in the Occluder and Air Bubble Detection (ABD) Modules. An investigation determined that a faulty component on the modules' application board caused these failures. The affected units are identified by catalog number 801763 and specific serial number ranges.

Users of the Terumo Advanced Perfusion System 1 should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the recall and corrective actions.

The recalled product

Product: System 1 base 100/120V 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 perfusionist who is experienced in the…
Manufacturer: Terumo Cardiovascular Systems Corporation
Category: Medical Device — Cardiovascular / Perfusion
Hazard: malfunction
device-failure
Affected units: 992

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 (8)

catalog number: 801763 and serial numbers: 0011-0335
0337-0610
1001-1034
1037-1049
1100
1103-1106
1109-1450
and 1452.

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 · malfunction