TAXUS Stent Recall: Paclitaxel - Eluting Stent Recall
Class 1 Recall: Boston Scientific Taxus™ Express2TM (paclitaxel-eluting) Coronary Stent
Date Recall Initiated: July 1, 2004
Product: Boston Scientific Taxus™ Express2TM paclitaxel drug-eluting coronary stent system; lot numbers 6294706 and 6365192
Use: The Taxus stent system consists of a stent (small metal tube) which is mounted on a balloon catheter. The stent is inserted into a blood vessel and advanced within the vessel to the narrowed section of the coronary artery. When the stent is correctly positioned, the balloon is inflated, causing the stent to expand. Expansion of the stent pushes the plaque aside, opening the narrowed section of the artery restoring normal blow flow to the heart. The balloon on the stent delivery catheter is then deflated and the delivery catheter is removed from the patient. The stent remains permanently implanted supporting the newly opened section of the vessel. A drug, paclitaxel, is slowly released into the artery wall around the stent. The drug reduces the chance of vessel narrowing again in the stented segment of the vessel.
Recalling Firm: Boston Scientific Corporation 1 Scimed Place Maple Grove, MN 55311-1565
Reason for Recall: Characteristics in the design of these two lots resulted in failure of the balloon to deflate and impeded removal of the balloon after stent placement.
Public Contact: Boston Scientific Corporation
Tel: 800-832-7822
FDA District: Minneapolis
FDA Comment: Impeded balloon deflation can result in significant patient complications, including emergency coronary artery bypass graft surgery and death. Hospitals should immediately discontinue use of any affected units. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.
For additional information about our TAXUS Stent lawyers and a complimentary consultation, speak to a Client Relations representative at Weitz & Luxenberg today! Please fill out this simple form, call toll free 1 (800) 476-6070 or e-mail us at Clientrelations@weitzlux.com
.Weitz & Luxenberg is no longer accepting Taxus Stent cases.
see also:
Paclitaxel-Eluting Stent Recall
TAXUS Stent Laywer - TAXUS Stent News & Warnings: TAXUS Stent Class 1 RecallTAXUS Stent Recall Class 1 Paclitaxel Eluting
Bare Metal Stent Recall
Class 1 Recall: Boston Scientific Express2TM (bare metal) Coronary StentTaxus Stent Recall: Boston Scientific Class 1 bare metal recall
News & Warnings
TAXUS Stent research resourcesYou can use this section to do research about the TAXUS stent recall from sources such as the FDA
