CLASS II Device recall · Reported 25 Jul 2012 · FDA Enforcement Report

Terumo Advanced Perfusion System System 1 base 220/240V recalled

Terumo Cardiovascular Systems is recalling Terumo Advanced Perfusion System System 1 base 220/240V, distributed nationwide in the US. The recall was initiated on 18 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number 801764 and serial number 0006-1441

Quantity recalled648 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2043-2012
FDA event ID: 61479
Recalling firm: Terumo Cardiovascular Systems, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 18 Jun 2012
FDA classified: 19 Jul 2012
Reported: 25 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

18 Jun 2012	Recall initiated by company
19 Jul 2012	Classified by FDA	+31 days
25 Jul 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (oversensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syste

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I 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 operation of Sarns or similar equipment.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen.

Nationwide

Questions about this recall

Is Terumo Advanced Perfusion System System 1 base 220/240V recalled?

Yes. Terumo Cardiovascular Systems recalled Terumo Advanced Perfusion System System 1 base 220/240V on 18 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-2043-2012.

Why was it recalled?

Which lots are affected?

Catalog Number 801764 and serial number 0006-1441

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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