Recall Z-0733-04 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Boston Scientific Corporation
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port System, Model # M001452380, Catalog #45-238
| 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 | 199 |
| Distribution | Shipments were nationwide to 158 medical facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031844 | VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 Boston Scientific Corp, Jul 15, 2003 |