A global recall has been issued for Boston Scientific’s Chariot Guiding Sheath due to the risk of shaft separation. According to a U.S. Food and Drug Administration (FDA) recall posted on December 11th, all UPNs of the Chariot Guiding Sheaths have been recalled. Boston Scientific recalled the devices, which are used to introduce devices during peripheral vascular procedures, on November 19, 2015.
According to the FDA, fourteen complaints of shaft separation have been received by Boston Scientific. Shaft separation occurs either when the device is being prepared or used, and can lead to serious complications. The FDA warns that “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. Obstruction of blood flow can result in injuries such as stroke, kidney damage or damage to the intestines or limbs.”
Healthcare facilities have been urged to stop using Chariot Guiding Sheaths and return unused units to Boston Scientific. Since the risk of shaft separation and embolized fragments may not have been known during procedures, physicians are advised to contact affected patients to inform them of the recall and assess their condition.