Recall Z-2009-2011

Reason for recall

The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However this is not stated in the IFU. The firm is conducting

FDA-determined cause: Device Design

Action taken

SEE UPDATE BELOW IN ALL CAPS. The firm, Terumo Cardiovascular Systems (Terumo CVS), sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that the product's Indications For Use (IFU) are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However, this is not stated in the IFU. In addition, the customers were instructed to read and understand the changes and clarifications to the product's IFU; review the Medical Device Correction notice; assure that all users are aware of this notice, and confirm receipt of this communication by faxing the attached Customer Response Form via fax to: Terumo CVS Customer Service at 800-292-6551 (US only). If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818. Customers Service hours: Monday-Friday, 8AM-6PM. ON 8/30/2011 THE FIRM ISSUE A LETTER ENTITLED "URGENT MEDICAL DEVICE RECALL" THAT STATED "AFTER FURTHER CONSIDERATION, TERUMO CVS DECIDED TO DISCONTINUE SALES OF THE WEIGHTED FLEXIBLE SUCKER AND IS ASKING USERS TO RETURN ALL UNUSED PRODUCT" TO THE FIRM.