Z-2449-2012Class II

Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for...

Name: Z-2449-2012 Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-09-20
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-09-20 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and... on 2012-09-20. FDA classified it as Class II and gives the reason as "Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2449-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Posted: 2012-09-25
Terminated: 2014-01-13
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Flow Module 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 one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat
Root cause tag: manufacturing process
FDA root cause: Process control
Action: TERUMO sent an Urgent Medical Device Recall letter dated September 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Medical Device Recall notice; assure that all users are aware of the notice; and confirm receipt of the communication by faxing the attached Customerr Resonse Form to 1-734-741-6149. Terumo CVS will send a representative to each affected US account to replace the affected devices and return the affected devices 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 question customers should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.
Quantity in commerce: 72 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.
Product codes and lots: Catalog number: 802018 and serial numbers: 00122,00132, 00137, 00321-00337, 00339, 00340, 00342-00389,00391-00439, 00441, 00442, 00444-00455, 00457, 00459, 00460, 00466, 00467, 00475, and 00488.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2449-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2449-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25

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)