Z-0438-2007

Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040

Name: Z-0438-2007 Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040
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, 4 inch diameter Roller Pump; Model 801040 on 2006-10-16. The reason FDA records is "The roller pump will pause in response to a pressure alarm condition, as designed, but then may not resume operation as expected after the alarm condition has been cleared". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0438-2007
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, 4 inch diameter Roller Pump; Model 801040.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The roller pump will pause in response to a pressure alarm condition, as designed, but then may not resume operation as expected after the alarm condition has been cleared.
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: 1,399
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 0030, 0033, 0034, 0036, 0037, 0038, 0041, 0042, 0043, 0045 through 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075-0096, 0098 through 0119, 0122, 0124, 0125, 0127 through 0163, 0165 through 0170, 0172, 0173, 0175, 0177, 0179, 0181, 0182 through 0231, 0233 through 0278, 0280 through 0481, 0483 through 0587, 0700 through 0753, 0757 through 0766, 0768, 0769, 0771 through 0787, 0789 through 0793, 0795 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1028, 1030 through 1051, 1053 through 1075, 1079 through 1268, 1270 through 1936, 1947 through 1951, 2000 through 2029, 2033, 2034, 2036 through 2038, 2042 through 2182 and 2186 through 2205.

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)