Agency classClass IIOur severity:High FDA (Devices)·Z-1957-2012·Announced 2012-07-18

Terumo Advanced Perfusion System 1 Central Control Module Recall

Terumo is recalling 992 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.

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 involves a high-risk medical device used for cardiopulmonary bypass where loss of control functions or alarms poses a significant risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 992 units of the Central Control Module for System 1 (System 1 Base, 100/120V). The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The affected modules are identified by catalog number 801763 and specific serial number ranges.

The recall was initiated after Terumo received reports that the Central Control Monitor (CCM) lost partial or full functionality. Symptoms associated with the malfunction include full or partial loss of display, loss of control functions, inability to distinguish various status, alert, or alarm conditions, and inability to operate the touch screen.

The affected units were distributed worldwide, including the United States and numerous international locations. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.

The recalled product

Product: Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used…
Manufacturer: Terumo Cardiovascular Systems Corporation
Category: Medical Device — Cardiovascular / Perfusion
Hazard: malfunction
loss-of-function
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
1109-1445
and 1447-1450.

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