Z-0103-04

Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040

Name: Z-0103-04 Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040
Creator: Terumo Cardiovascular Systems Corp
Published: 2003-10-16
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2003-10-16 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040 on 2003-10-16. The reason FDA records is "The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0103-04
Status: Terminated
Initiated: 2003-10-16
Posted: 2003-11-07
Terminated: 2005-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.
FDA root cause: Other
Action: Letters entitled Urgent Safety Alerts were sent to each customer on 10/16/03. Customers were made away of the problem and advised to develop a protocol for action, in case the problem occurred in their facility.
Quantity in commerce: 263
Distribution: United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Singapore, South Korea.
Product codes and lots: Serial numbers 0001 through 0599.

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)