Boston Scientific Chariot Guiding Sheaths Recalled Due to Risk of Shaft Separation

Boston Scientific has issued a global recall of its Chariot Guiding Sheath due to the risk of shaft separation, the U.S. Food and Drug Administration (FDA) announced in a December 11th recall. The recall was initiated on November 19, 2015 and affects all UPNs of the Chariot Guiding Sheaths. The devices are used to guide devices during peripheral vascular procedures.

According to the FDA notification, fourteen complaints of shaft separation have been received by Boston Scientific. Shaft separation occurs either when the device is being prepared or used. Complications of shaft separation can be serious. “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.” the FDA warns.

Healthcare facilities are instructed to stop using Chariot Guiding Sheaths and return unused units to Boston Scientific. Additionally, physicians are advised to contact affected patients because the risk of shaft separation and embolized fragments may not have been known during procedures. Physicians should assess patients’ post-procedure condition, the FDA notification states.

from Parker Waichman http://www.yourlawyer.com/blog/boston-scientific-chariot-guiding-sheaths-recalled-due-to-risk-of-shaft-separation/