Medical device maker Boston Scientific has voluntarily recalled the Chariot Guiding Sheath worldwide because of the risk of shaft separation, which could cause permanent injury or death.
The recall, which was initiated on November 19, 2015, affects all lot numbers of the Chariot Guiding Sheaths. A full list of lots numbers can be found on the Food and Drug Administration (FDA) web site.
These recalled Chariot Guiding Sheath devices are for use in the introduction of interventional devices during peripheral vascular procedures (procedures to relieve a blockage in the arm or leg). Boston Scientific has received fourteen complaints of shaft separation, four of which involved separation of the distal shaft. These separations occurred during device preparation or use. The most serious outcome of separation is embolism of device fragments, which could lead to the obstruction of blood flow or the need for additional intervention to remove a device fragment. Obstruction of blood flow can result in such injuries as stroke, kidney damage or damage to the intestines or limbs, according to the FDA.
The FDA has designated this a Class 1 recall, its most serious category. This category is reserved for situations where there is a reasonable probability that use of the affected device could result in serious injury or death.
The company has advised all affected health care facilities that have Chariot Guiding Sheaths in inventory to immediately discontinue using the devices and return unused sheaths to Boston Scientific. In addition, the company recommends that physicians contact all patients who have undergone procedures involving Chariot to confirm their status because shaft separation and embolized fragments may not have been recognized at the time of the procedure.
Physicians and health care facilities can direct questions to their Boston Scientific representative or they may call the company at 1-800-811-3211.