—#31767

Product

Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port System, Model # M001452380, Catalog #45-238

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K031844
Affected lot / code info: 791484, 791485

Why it was recalled

Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.

Root cause (FDA determination)

Other

Action the firm took

Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern: Shipments were nationwide to 158 medical facilities nationwide.

Timeline

Recall initiated: 2004-02-10
Posted by FDA: 2004-07-20
Terminated: 2005-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #31767. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.