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Boston Scientific Issues Class I Recall for Chariot Guided Sheath Medical Device

Legal News GavelEarlier this month, medical device manufacturer Boston Scientific announced that it has initiated a voluntary recall of its Chariot Guiding Sheath devices (CGS). The CGS devices were designed and manufactured to be used in peripheral vascular procedures. The U.S. Food and Drug Administration, which is responsible for overseeing the approval and safety of medical devices, among other things, has labeled the recall a Class I, the highest and most serious level of recall that the agency issues. The agency’s website defines a Class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

According to the recall, Boston Scientific has received reports that at least 14 of the CGS devices experienced shaft separation issues and other related issues that created complications in patients who were implanted with the CGS device. According to its statement announcing the recall, separation of the shaft can lead to life-threatening injuries like embolisms, blood flow obstruction, and emergency surgery to remove the device or its fragments.

A lawsuit involving a defective medical device is a type of product liability case that requires the plaintiff to prove that the device was either designed to be unreasonably dangerous or that the product suffered a manufacturing defect that rendered the specific device that the plaintiff received unreasonably dangerous. Here, plaintiffs who received a defective CGS device will likely contend that the product was unreasonably dangerous. To make this argument, the plaintiffs can use evidence and documentation from the FDA regarding the class I recall and show that the serial number of the device that they received is one of the serial numbers listed in the recall. To find your serial number, you may need to contact your physician and locate copies of your medical records.

Any health care facility that has unused CGS devices that fall within the specific allotment of defective devices has been instructed to discontinue use of the devices and return them to Boston Scientific. Also, Boston Scientific has encouraged physicians who implanted patients with a CGS device that falls within the specific allotment of defective devices to contact these patients and inquire about their post-surgical status. According to the company, the separation and embolization of CGS device fragments may not have been identified at the time of implantation.

If you or someone you know has suffered injuries due to a defective medical device, you may be entitled to compensation. At Moll Law Group, we have handled many medical device lawsuits and know just what it takes to go up against big medical device manufacturing companies. This type of injury can be devastating for a victim and his or her family, and in many cases it leads to life-altering, permanent disabilities. Our team of experienced and aggressive medical device lawyers represents clients throughout the United States, including in California, Texas, and New York. We are available to guide you through every step of the process and ensure that you receive the settlement or judgment that you and your family deserve. Call us now at 312-462-1700 or contact us online to set up your free, no-obligation consultation now.

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