Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-368, UPN Product No. M001453680, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.

Navilyst Medical, Inc. is recalling Vaxcel Ports and Vaxcel Ports with PASV Valve with valid expiration dates worldwide. Navilyst sent "Urgent Medical Device Recall - Immediate Action Required" letter/recall notification packages on May 13, 2010, via Federal Express to 471 domestic consignees; on May 14, 2010, via e-mail to 14 international consignees and to Boston Scientific Corporation (prior owner of the affected products) via facsimile and Federal Express. On June 3, 2010, Navilyst Medical sent Recall Notification Packages on behalf of Boston Scientific Corp. via Federal Express to 182 domestic consignees. The letter instructs the customer to immediately discontinue use of and segregate recalled product, complete and return the reply verification tracking form to fax# 518-742-4450 and package and return the recalled product to the address provided. If you have any question, please call Navilyst Medical, Inc., Customer Service at 1-800-833-9973 or Michael Duerr at 1-518-742-4571.