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U.S. Department of Health and Human Services

Medical Devices

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Boston Scientific Taxus™ Express2TM Coronary Stent

Class I Recall
Date Recall
Initiated:

July 1, 2004

[See also July 16, 2004 Recall for Express2TM (bare metal) Coronary Stent]

 

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 on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/Safety/Recalls/EnforcementReports/2004/ucm120305.htm. Scroll down to "Recalls and Field Corrections: Devices – Class I".