The Bard LifeStent Solo Vascular Stent is a medical device that is used to prop open arteries in the thigh. In September 2013, it was recalled because the deployment mechanism may malfunction and cause severe injuries to a patient, including heart attack, loss of a limb, and death. Affected products were manufactured and distributed between November 2011 and June 2012.
Need a Texas Medical Device Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by the Bard LifeStent Solo Vascular Stent, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
What is the Bard LifeStent Solo Vascular Stent?
The Bard LifeStent Solo Vascular Stent is an implantable, self-expanding stent and delivery system. It is used to prop open blood vessels in the legs. The stent is made from a mesh tube that is implanted in a blood vessel. The stent is implanted into a blood vessel with a long, thin device called the delivery catheter.
According to the manufacturer:
“The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 – 6.5 mm.
Class 1 Recall of Bard LifeStent
September 30, 2013 — The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall of the Bard LifeStent Solo Vascular Stent. The problem is that the delivery mechanism may not perform correctly. Problems could include failure to deploy, partial deployment, and difficult deployment.
Bard also sent an “Urgent Medical Device Recall Notification” via FedEx to all customers who received affected lots. The customers were informed about the problem and given instructions for returning the products.
Class 1 recalls are the most serious type of recall. They involves situations in which there is a reasonable probability that the use of the product will result in severe injury or death.
Side Effects of Bard LifeStent Solo Vascular Stent
- Bleeding
- Complications of bleeding
- Loss of limb
- Heart attack
- Stroke
- Vascular surgery
- Death
Additional Resources
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