Z-2737-2011

Large Roller Pump 6" Diameter, Catalog 816571, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The...

Name: Z-2737-2011 Large Roller Pump 6" Diameter, Catalog 816571, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-03-31
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-03-31 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Large Roller Pump 6" Diameter, Catalog 816571, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal... on 2011-03-31. The reason FDA records is "The firm has received multiple reports of the lower roller pump tube clamp mechanism failing to function in a small population of devices, making it difficult to remove or insert the tubing. If the failure occurs, the...". 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-2737-2011
Status: Terminated
Initiated: 2011-03-31
Posted: 2011-07-06
Terminated: 2013-08-28
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Large Roller Pump 6" Diameter, Catalog 816571, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The firm has received multiple reports of the lower roller pump tube clamp mechanism failing to function in a small population of devices, making it difficult to remove or insert the tubing. If the failure occurs, the clamp dial will no longer be able to control opening/closing of the tube clamp mechanism.
Root cause tag: design
FDA root cause: Device Design
Action: Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated March 21, 2011. The letter identified the product, the problem and the action needed to be taken by the customer. An additional URGENT MEDICAL DEVICE RECALL correction notification and cover letter was sent to all consignees on XX/XX/XX to explain the reason for the expansion of the recall and will provide an update to the timing of implementation of the field correction. Expansion now includes devices manufactured between 2006 and March 2012. The correction strategy is to issue the customers a letter and addendum to the Operator's Manual that specifies what the user should do in the event of a tube clamp failure for any reason. The letter states that the firm is still investigating the issue and the correction. The letter states that in the coming months when a resolution is identified, consignees may be contacted to make arrangements for a upgrade to the system. There is no specific timeline for the correction to be made. If you have any further questions, please call a Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours Monday - Friday, 8 Am - 6 Pm EST.
Quantity in commerce: 1988 devices.
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Argentina, Australia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Jordan, Korea, Kuwait, Malaysia, Mexico, Pakistan, Republic of Georgia, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, The Phillipines, Turkey, United Arab Emirates and Vietnam.
Product codes and lots: serial numbers 1001-6903

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)