The Recall Desk
HighFDA (Devices)·Z-2048-2012·Announced 2012-07-25

Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions

Terumo is recalling 26 Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

What this means for you

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 (heart-lung machine) with reported malfunctions (false alarms/over-sensitivity) that could impact patient safety during critical procedures, but no specific injuries or deaths are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 26 units of the Sarns Modular Perfusion System 8000 base, 4 pump 100V. The affected units are identified by Catalog Number 16409 and serial numbers 1001-1026. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

The recall is being conducted because Terumo received several reports over the last three years of malfunctions in the Air Bubble Detection System. These malfunctions manifested as over-sensitivity and false alarms, with various root causes identified. The issues occurred in systems that were either excluded from prior corrective actions or in systems where previous fixes did not resolve the problem.

The affected units were distributed worldwide, including the United States and numerous international locations such as Argentina, Brazil, Canada, China, France, Germany, India, Italy, Japan, and the United Kingdom. Healthcare facilities and users of these specific serial numbers should contact Terumo Cardiovascular Systems Corporation for instructions on corrective actions or replacement.

The recalled product

Product
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 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 by a qu
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiopulmonary Bypass
Hazard
Affected units
26

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 16409 and serial number 1001-1026

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 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 11 products in this recall →

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