Boston Scientific Corporation Stent Recall Overview

One of the most promising areas of medical advancement in recent decades is that which involves the heart and circulatory system. Procedures and repairs that were impossible just a few years ago are nearly commonplace in present times. Boston Scientific Corporation of Maple Grove, Minnesota was one of the leaders of this heart movement, and they have introduced several products into the marketplace that aided in the prognosis of patients.

One of Boston Scientific's most promising product lines was their introduction of different types of stents onto the market, and these products helped surgeons widen the passageways in the blood vessels leading to the heart. However, two of their stents in particular encountered serious problems, each of which led to a recall. The details of these recalls are described below.

Boston Scientific Express2TM (bare metal) coronary stent system

This product was introduced to the market with a specific purpose in mind. This stent was mounted onto a balloon catheter and inserted into a blood vessel. Once inside, the balloon attached to the stent was inflated, causing an expansion of the stent. The intended result was to open the pathway within the blood vessels leading to the heart. When the process was complete, the balloon was deflated and removed, and the stent remained in place to maintain the opening, creating better circulation.

However, on July 16, 2004, this product was recalled because an inherent design flaw caused the balloon to fail to deflate, which impeded its removal. This was obviously a serious problem, as it resulted in necessary emergency coronary artery bypass graft surgery and death in several instances. This situation was classified as a “Class I” recall by the FDA, which is the most serious.

Boston Scientific Taxus™ Express2TM paclitaxel drug-eluting coronary stent system

Just two weeks before the recall described above, Boston Scientific’s Taxus Express stent system was also recalled. This product essentially served the same function as the Scientific Express, in that it was used to open arteries and blood vessels leading to the heart. There was an additional purpose with this product, however - the Taxus Express stent system, once in place inside the patient, released a drug, paclitaxel, into the artery wall around the stent. This drug was used to reduce the chance of subsequent narrowing of the blood vessel.

The problem with this device was that, like above, the balloon failed to deflate, and the stent in effect failed to “elute” the drug. This led to serious heart complications in patients, and these injuries included emergency surgery and the increased likelihood of heart attacks, strokes, blood clots and death as a result.

If you have suffered from heart problems as a result of using either of these products, seek medical attention immediately. You also need to contact an experienced trial attorney for a full consultation in order to protect and enforce your rights.