Z-0436-2007

Terumo Advanced Perfusion System 1; Central Control Monitor; Catalog number 802100

Name: Z-0436-2007 Terumo Advanced Perfusion System 1; Central Control Monitor; Catalog number 802100
Creator: Terumo Cardiovascular Systems Corp
Published: 2006-10-16
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2006-10-16 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1; Central Control Monitor; Catalog number 802100 on 2006-10-16. The reason FDA records is "Pump may stop without an audible tone as a result of quickly clearing the internal pump alarm condition or overpressure alert/alarm condition". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0436-2007
Status: Terminated
Initiated: 2006-10-16
Posted: 2007-02-14
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1; Central Control Monitor; Catalog number 802100.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Pump may stop without an audible tone as a result of quickly clearing the internal pump alarm condition or overpressure alert/alarm condition.
FDA root cause: Other
Action: Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.
Quantity in commerce: 683
Distribution: Worldwide distribution ---- including USA and countries of 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 0036, 0045, 0047 through 0049, 0052, 0054, 0055, 0058, 0065 through 0067, 0069, 0071 through 0094, 0096 through 0254, 0256 through 0276, 0278 through 0301, 0303 through 0370, 0372 through 0376, 0378 through 0384, 0386 through 0686, 0688, 0690 through 0702, 0705 and 0706 through 0751.

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)