Boston Scientific’s Chariot Guided Sheath Faces FDA Recall
December 15th, 2015|
The U.S. Food and Drug Administration (FDA) is charged with the task of regulating the safety of medical products in our country. When a product doesn’t meet certain standards, the agency initiates a recall. One of the latest potentially defective medical products to face an FDA recall is Boston Scientific’s Chariot Guided Sheath.
A long tube that’s used to diagnose and clear blockages in a patient’s blood vessels, reports indicate the shaft of the Chariot Guided Sheath’s catheter can separate from the insertion device during an implant procedure.
Officials say the pieces that can break free from the device may become lodged in a patient’s circulatory system, which can lead to stroke, heart attack, or damage to the kidneys. According to the Boston Business Journal, there have been 21 reports received of the Chariot device malfunctioning. No fatalities have been reported.
This is the second recall involving the company this year. In November, Boston Scientific partnered with the FDA to recall the RotaWire Elite Guidewire system after documents surfaced indicating the device could break in a patient’s body and cause serious harm.
Being aware of the risks that medical products can pose is one of the best ways to avoid injury. That’s why the defective medical device lawyers at Ferrer, Poirot & Wansbrough are hopeful this information helps keep you and your loved ones safe.