Z-0206-2009

Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States...

Name: Z-0206-2009 Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2008-07-18
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2008-07-18 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. For use for up to 6 hours in the extracorporeal... on 2008-07-18. The reason FDA records is "Local pump controls including start/stop button, select button and manual button may not function". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0206-2009
Status: Terminated
Initiated: 2008-07-18
Posted: 2008-10-31
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Local pump controls including start/stop button, select button and manual button may not function.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were notified by recall letter dated 7/18/08 and were provided with revised operating instructions telling them to revert to the central control module should these problems occur.
Quantity in commerce: 300
Distribution: Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
Product codes and lots: Serial numbers 0006 through 0066, 0100 through 0322 and 1001 through 1017.

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)