Z-1403-06

Terumo Advanced Perfusion System 1 Roller Pump 6 inch diameter; Catalog No. 801041

Name: Z-1403-06 Terumo Advanced Perfusion System 1 Roller Pump 6 inch diameter; Catalog No. 801041
Creator: Terumo Cardiovascular Systems Corp
Published: 2006-06-30
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2006-06-30 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1 Roller Pump 6 inch diameter; Catalog No. 801041 on 2006-06-30. The reason FDA records is "The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1403-06
Status: Terminated
Initiated: 2006-06-30
Posted: 2006-08-22
Terminated: 2008-06-19
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Roller Pump 6 inch diameter; Catalog No. 801041.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.
FDA root cause: Other
Action: The firm replaced the graphics driver board on complaint units as user complaints were received. The firm notified all users of the problem and the presence of an alternative method of pump speed control via recall letter dated 6/30/06.
Quantity in commerce: Recalls Z-1403-1405-2006- 1,135 systems in the U.S. plus 723 internationally.
Distribution: Worldwide-USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Product codes and lots: Serial numbers 0033 through 1263.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)