The Innova Stent System was designed to aid in the treatment of symptomatic de novo or restenotic lesions, each of which typically occur in either the native superficial femoral artery or the proximal popliteal artery. However, the U.S. Food and Drug Administration (FDA) initiated a class 1 medical device recall after significant evidence suggested that Innova Stents carry a reasonable probability of causing serious injury or death. Accordingly, over 500 Boston Scientific Innova Stents have been recalled because many have failed to properly deploy upon insertion into patients. Due to the severity of these complications, many patients may file an Innova Stent System lawsuit.
If you or a loved one has been injured by an Innova Stent System, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Innova Stent System Recall Overview
Boston Scientific believes that the Innova Stent System is an innovative approach in the treatment of peripheral vascular lesions in the arteries above the knee. The device is made up of a nitinol, self-expanding bare-metal stent found on a low-profile delivery system that enables a wide range of versatility. The design features a closed cell system that significantly improves radial force and fracture resistance. Accordingly, another similar open cell feature along the stent body ensures that the device will not compromise flexibility in place of dexterity. The surgical procedure in which the device is implanted is aided by a tri-axial catheter shaft designed to provide added support and placement accuracy.
Joe Fitzgerald, Senior Vice President and President of Boston Scientific’s Endovascular Unit states that “The Innova Stent is engineered to offer an advanced solution in treating
blockages within these critical arteries.” Fitzgerald then continues to support the device by acknowledging that the “design is intended to improve blood flow and provide greater long-term stent durability, ultimately improving the overall quality of life for patients with peripheral artery disease.” Unfortunately, recent reports of adverse events associated with the device may be responsible for recipients filing an Innova Stent System lawsuit.
Boston Scientific, world renowned for their work in the field of less-invasive medical devices, has assisted in the treatment of millions of patients, by providing alternatives to traditional invasive surgery since 1969. However, June 16, 2011 witnessed a recall of over 500 Innova Stents that would forever tarnish the companies once pristine name. Numerous complaints regarding the proper deployment of Innova Stent Systems have been reported. In these adverse events, faulty Innova Stent Systems may fail to deploy properly upon insertion and cause severe injuries to the vessel wall. As a result, patients may experience severe pain and suffering, extended surgical procedures, or even death. Due to the severity of these complications, many patients may seek compensation for their pain and suffering by filing an Innova stent system lawsuit.
Products Affected By The Innova Stent System Recall
The recall affects the Boston Scientific Innova Over-the-Wire Self-Expanding Stent Systems. A complete list of affected stents is listed in the FDA’s official recall notice that was issued on May 19, 2011. However, the recall does not include any stents which have already been successfully implanted into patients.
For more information regarding the Innova Stent System recall and the affected lot numbers, please refer to the official FDA recall notice.
Class 1 Medical Device Recall
After numerous reports of injuries caused by Boston Scientific’s Innova Stent System, the FDA issued an immediate recall on all of the defective devices. Due to the severity of the injuries that Innova Stents inflict on vessel walls when they fail to deploy properly, the FDA decided to categorize the recall as a Class 1. Class 1 recalls represent the FDA’s most serious recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Due to the severity of these complications, many patients may seek compensation for their pain and suffering by filing an Innova stent system recall lawsuit
Do I Have An Innova Stent System Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Innova Stent System lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by an Innova Stent System, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.