Medical device manufacturer Boston Scientific has recalled 31,798 Vici Venous Stent Systems because of a risk of injury or death. According to an alert issued by the U.S. Food and Drug Administration (FDA), the federal agency that regulates medical device safety, the recalled Vici SDS and Vici RDS Venous Stent Systems are used to treat blocked veins or obstructions in narrow veins.
The alert states that the stents could potentially migrate or move out of place from where they were initially implanted, causing issues and potentially dangerous complications.
A Class I Recall
The FDA has designated this as a Class I recall, which is the most serious type of recall for medical devices that could cause severe injury or death. The FDA warns that a migrated stent may require another surgery or catheter procedure to retrieve it, which increases the risk to the patient including possible damage to the blood vessel, heart walls, or other vital organs.
So far no deaths have been reported. But it is important to note that if a stent migrates to the heart, it could become life-threatening, sometimes causing death. There have been 17 complaints and reported injuries related to this issue, but no fatalities. The recalled stents were distributed nationwide between Sept. 21, 2018, and April 9, 2021. Boston Scientific is urging customers to stop using the device and return them to the company.
Product Liability Issues
Medical device manufacturers have a responsibility to make products that are safe for consumers. There is no question that patients suffer more stress and trauma when medical devices malfunction because often they are placed inside the patient’s body and additional surgeries or medical procedures are almost always required to remedy the situation. Not only are patients forced to undergo painful procedures to have these defective devices removed and/or replaced, but they also face significant financial burdens in the form of medical expenses and lost income, not to mention the anxiety and stress that comes with all of that.
If you have received these recalled stents and have suffered from complications as a result of device migration, you may be able to file a product defect lawsuit against the manufacturer seeking compensation for losses such as medical expenses, lost income, hospitalization, unnecessary surgeries, rehabilitation costs, pain and suffering, and emotional distress. An experienced product defect lawyer can help you better understand your legal rights and options.