Z-0445-2009

Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required)...

Name: Z-0445-2009 Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required)...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2008-04-17
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2008-04-17 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763 on 2008-04-17. The reason FDA records is "The power supply may fail to charge the batteries due to various hardware malfunctions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0445-2009
Status: Terminated
Initiated: 2008-04-17
Posted: 2008-12-29
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The power supply may fail to charge the batteries due to various hardware malfunctions.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo notified U.S. consignees via Urgent Medical Device Correction: Safety Advisory recall letter dated 4/17/08 and international consignees were notified via email on 4/24/08 informing them of the potential problem.
Quantity in commerce: 256
Distribution: Worldwide distribution: USA, Australia, Belgium, Canada, Colombia, Dominican Republic, Honduras, Hong Kong, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, and Viet Nam.
Product codes and lots: Serial numbers 0396 through 1049.

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)