Z-0356-2009

Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extracorporeal...

Name: Z-0356-2009 Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extracorporeal...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2008-07-18
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2008-07-18 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extracorporeal circulation of blood for arterial perfusion, regional... on 2008-07-18. The reason FDA records is "Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0356-2009
Status: Terminated
Initiated: 2008-07-18
Posted: 2008-12-11
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were notified of the problem via recall letter dated 7/18/08. The firm began conducting field upgrades on the roller pumps in 07/08. For questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818.
Quantity in commerce: 269
Distribution: Worldwide Distribution including USA and countries of Australia, Belgium. Canada, Columbia, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
Product codes and lots: Serial numbers 1001 through 1008 and 4009 through 4269.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)