Z-0325-2007

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041

Name: Z-0325-2007 Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041
Creator: Terumo Cardiovascular Systems Corp
Published: 2004-10-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2004-10-12 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041 on 2004-10-12. The reason FDA records is "Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0325-2007
Status: Terminated
Initiated: 2004-10-12
Posted: 2006-12-30
Terminated: 2007-02-01
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
FDA root cause: Other
Action: U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.
Quantity in commerce: 4,740 for all affected products
Distribution: Worldwide Distribution-USA and countries 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, 0034, 0036, 0038, 0041 through 0043, 0045, 0047 through 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098, 0099, 0102 through 0116, 0118, 0124, 0127 through 0136, 0138 through 0146, 0148 through 0151, 0153 through 0163, 0165 through 0170, 0172, 0173, 0175, 0179, 0181 through 0187, 0189 through 0200, 0202 through 0231, 0233 through 0240, 0242 through 0278, 0281 through 0302, 0304 through 0481, 0483 through 0587, 0700 through 0753, 0757, 0758, 0760 through 0769, 0771 through 0787, 0789 through 0793, 0795 through 0866, 0868 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1001, 1004 through 1015, 1017, 1019 and 1024 through 1027.

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)