Z-0307-2007

Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only)

Name: Z-0307-2007 Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only)
Creator: Terumo Cardiovascular Systems Corp
Published: 2006-11-10
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2006-11-10 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only) on 2006-11-10. The reason FDA records is "Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0307-2007
Status: Terminated
Initiated: 2006-11-10
Posted: 2006-12-27
Terminated: 2008-06-19
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
FDA root cause: Other
Action: A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.
Quantity in commerce: 208
Distribution: Worldwide, including USA, 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: All units Serial numbers 0006 through 0213.

Product code DTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)