Z-2443-2012Class II

Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD

Name: Z-2443-2012 Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-09-10
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-09-10 / Terminated

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation... on 2012-09-10. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2443-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-10
Posted: 2012-09-24
Terminated: 2014-01-13
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD 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 perfusionist who is experienced in the operation of Sarns or similar equipment.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unli
FDA root cause: Release of Material/Component prior to receiving test results
Action: Terumo CVS issued an URGENT MEDICAL DEVICE Recall letter dated September 10, 2012 to alert all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that a Terumo CVS representative will contact all affected US account.to schedule an appointment to replace the affected product. The affected product will be return to Terumo for destruction. Non-US Terumo Affiliates will be instructed to remove the devices from the field and provide a record of destruction. For questions call the Terumo CVS Customer Service at 1-800-521-2818
Quantity in commerce: 150 units
Distribution: Worldwide and US Nationwide Distribution
Product codes and lots: Catalog number: 802018 and serial numbers: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, and 00823-00847.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2443-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2443-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-23

Product code DTQ

K022947Class IIAdvanced Perfusion System 1 (100/120 Volt),advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 InchTerumo Cardiovascular Systems Corp. / cleared 2003-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)