C.R. Bard has issued a Class 1 recall of the LifeStent Solo Vascular System because the deployment mechanism can malfunction. This can cause life-threatening patient injuries, including heart attack, stroke, loss of a limb, and death.
What is the Bard LifeStent Solo Vascular Stent?
The Bard LifeStent Solo Vascular Stent is a medical device that consists of two parts: a stent and a delivery system. The sent is made of metal mesh in a tube-shape that self-expands. The delivery system is used to implant the stent into a blood vessel in the thigh. When it expands, it props open the blood vessel.
The description according to C.R. Bard:
“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.
What is the problem?
September 30, 2013 — The U.S. Food and Drug Administration (FDA) has recalled the Bard LifeStent Solo Vascular Stent after receiving reports of defective delivery systems. The problems include partial deployment, failure to deploy, and difficult deployment. Products included in the recall were manufactured and distributed from November 2011 until June 2012.
All customers who received recalled products have been sent a FedEd with an “Urgent Medical Device Recall Notification.” The notification describes the problem and instructs customers to return the product.
Side Effects of the Bard LifeStent Solo Vascular Stent
- Complications of bleeding
- Loss of limb
- Heart attack
- Vascular surgery