Due to Reports of Shaft Separation Boston Scientific Recalls Chariot Guiding SheathsDec 14, 2015
Following reports of shaft separation, Boston Scientific has globally recalled its Chariot Guiding Sheath. According to a U.S. Food and Drug Administration (FDA) recall notice posted December 11th, the recall was initiated on November 19, 2015 and affects all UPNs of the Chariot Guiding Sheaths.
The recalled devices are used to guide devices during peripheral vascular procedures. The FDA states that Boston Scientific has received fourteen complaints of shaft separation and that this occurs 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 should stop using Chariot Guiding Sheaths and return unused units to Boston Scientific, FDA states. 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.