Recall Z-1881-2010 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Navilyst Medical, Inc
Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-303, UPN Product No. M001453030, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
| Date | Jul 1, 2010 (initiated May 13, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 d |
| Distribution | Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903364 | GERARD MEDICAL, INC. TRIM-PORT Gerard Medical Enterprises, Inc., Oct 31, 1990 |
| K942623 | TRIMPORT Gerard Medical Enterprises, Inc., Aug 23, 1994 |
| K945250 | TRIMPORT Gerard Medical Enterprises, Inc., Mar 7, 1995 |
| K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) Gerard Medical Enterprises, Inc., May 24, 1996 |