—#39283

Product

Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

FDA product code: LLD — Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K032375, K032600
Affected lot / code info: 791549, 915868, 919482, 922594, 923705, 1000906, 1001279, 1003265, 1022911, 1034615, 922594D, 923705D

Why it was recalled

Potential for port housing separation after implantation.

Root cause (FDA determination)

Other

Action the firm took

A recall package issued to direct accounts on 6/8/05. Hospitals are instructed to return product in inventory, notify physicians, evaluate patients and explant devices whenever possible.

Recalling firm

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

Distribution

Distribution pattern: Product shipped to 56 medical facilities throughout the U.S.

Timeline

Recall initiated: 2005-06-08
Posted by FDA: 2005-06-30
Terminated: 2007-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39283. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.