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