Recall Z-0946-05 · LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal

Boston Scientific Corporation

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.

Date	Jun 30, 2005 (initiated Jun 8, 2005)
Status	Terminated
Reason	Potential for port housing separation after implantation.
Root cause	Other
Action	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.
Distribution	Product shipped to 56 medical facilities throughout the U.S.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K032375	VAXCEL PORT, MODELS 45-336 AND 45-338 Boston Scientific Corp, Aug 19, 2003
K032600	VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 Boston Scientific Corp, Sep 9, 2003