Recall Z-0734-04 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Boston Scientific Corporation
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port, Implantable Port System, Model # M001453660, Catalog #45-366
| Date | Jul 20, 2004 (initiated Feb 10, 2004) |
| Status | Terminated |
| Reason | Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter. |
| Root cause | Other |
| Action | Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports. |
| Quantity | 308 units |
| Distribution | Shipments were nationwide to 158 medical facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030083 | VAXCEL WITH PASV PORT Boston Scientific Corp, Jan 28, 2003 |