Z-0931-2007

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

Name: Z-0931-2007 Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041
Creator: Terumo Cardiovascular Systems Corp
Published: 2005-08-01
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2005-08-01 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041 on 2005-08-01. The reason FDA records is "The tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0931-2007
Status: Terminated
Initiated: 2005-08-01
Posted: 2007-06-30
Terminated: 2008-02-23
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: The tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing.
FDA root cause: Other
Action: The firm is visiting the consignees as complaints are received and making corrections. Corrections were made in August 2005 and April 2006 to date. Other units will be repaired if complaints are received and the firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and appropriate action to take should it occur.
Quantity in commerce: 1982 total for both models
Distribution: Worldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, Singapore, South Africa, Taiwan, Thailand and United Arab Emirates.
Product codes and lots: Serial number range 0033 through 1308 may be affected by this problem. Serial numbers 1060 and 1148 have been corrected.

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)