Boston Scientific Express Stent
Quick Facts
Boston Scientific Express Stent Reference Guide
Date Approved
September 26, 2002
Manufacturer
Boston Scientific Corp.
Status
Recall June 13, 2004
September 26, 2002
Manufacturer
Boston Scientific Corp.
Status
Recall June 13, 2004
Approved Uses
Angioplasty
Complications
Artery Blockage
Blood Clots
Heart Attacks
Stroke
Death
Related Topics
Boston Scientific Taxus Stent
Johnson Johnson Cypher Stent
Drug Coated Stents
Blood Clots
Heart Attacks
Stroke
Diseases
Defective Medical Devices
Boston Scientific Express Stent
The FDA has recalled Boston Scientific Express2TM (bare metal) coronary stents. The Express2™ 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.
The FDA recalled the stents because of characteristics in the design of the stent system caused failure of the balloon to deflate and impeded removal of the balloon after stent placement. 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.
If you or a loved one suffered injuries from a Boston Scientific Express stent, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.
Boston Scientific Express StentRSS Feed
Recall for Boston Scientific Implantable Defibrillators
Mar 16, 2010 | Parker Waichman Alonso LLP
A massive recall is being issued for seven brands of Boston Scientific implantable heart defibrillators. The recall is being issued because Boston Scientific has determined that it did not get approval from federal regulators for changes to its manufacturing processes. According to a Boston Scientific press release, the company is halting sales and retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators...
Lawsuits Allege Medtronic, Other Firms Illegally Marketed Surgical Ablation Products
Jul 16, 2009 | Parker Waichman Alonso LLP
Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in Texas. According to The Wall Street Journal, the lawsuits were filed by former employees of the companies.Allegations of kickbacks by medical device makers are nothing new. For example, in...
Drug-coated stents carry higher clot risk?
Nov 29, 2006 | UPI
The Cleveland Clinic said its analysis found that patients with drug-eluting stents have a higher risk of late thrombosis. In fact, the Ohio-based center said patients implanted with the drug-coated devices designed to prevent re-closing of the coronary artery, a condition known as restenosis may have as much as a four- to five-fold greater risk for late thrombosis, or blood-clot formation, compared to patients implanted with the earlier generation, bare-metal stents. "Our analysis found...
Study: Blood-clot risks higher in drug-coated stents
Sep 8, 2006 | AP
Boston Scientific found a slightly higher risk of blood clotting in patients implanted with its newer drug-coated stents compared with older bare-metal ver sions, a company spokesman said yesterday. The medical device maker reported the finding of its own new study to the U.S. Food and Drug Administration shortly after completing an analysis in late June, and met with the agency Aug. 1 to discuss the finding, company spokesman Paul Donovan said. The Natick, Mass. based company reviewed...
Class 1 Recall: Boston Scientific Express2TM (bare metal) Coronary Stent
Jul 23, 2004 | www.fda.org
The Express2 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...