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FDA Issues Class 1 Recall for Boston Scientific Medical Device

The Food and Drug Administration has issued a Class 1 recall of Boston Scientific's "Chariot" catheter device that debuted on the market earlier this year. A Class 1 recall is the most serious of its kind, which indicates that the device can cause serious harm to patients or even death.

According to Boston Business Journal, Boston Scientific is Massachusetts' largest manufacturer of medical devices that are used all over the world. Their Chariot device was designed to provide a pathway for other, thinner implements that help diagnose and treat blockages in blood vessels. The FDA now has 21 reports of "adverse events" due to the product breaking into pieces while still inserted inside a patient.

"The most severe outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment," a statement from Boston Scientific reads. "Obstruction of blood flow can result in injuries such as stroke, kidney damage or damage to the intestines or limbs."

Not the First Recall

According to the FDA's database, the Chariot device recall is the second for the Boston Scientific this year. The first was associated with its RotaWire Elite Guidewire device, which was used to widen arteries. Similar to IVC filter recalls that have become prevalent among other manufacturers, the guardwire device broke up inside of patients and is responsible for at least one patient death.

If you or a loved one has been hurt by a defective medical device, then the time to explore your legal options is now. At Jackson Allen & Williams, LLP, our team of dedicated and knowledgeable Dallas personal injury attorneys have more than half a century of legal experience in this practice area. We are committed to advocating for those wrongly injured—including patients who have been harmed due to the inappropriate actions of medical device manufacturers.

The relief you deserve can be fought for. Contact us today to start exploring your options.

Categories: Defective Products
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