—#99575

Product

System 1 Base 110V, Catalog 801763, 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

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: serial numbers 0011-1438.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-03-31
Posted by FDA: 2011-07-06
Terminated: 2013-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99575. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.