Boston Scientific has issued a global voluntary recall of its Chariot-brand guiding sheath, a device intended to assist in the introduction of international devices used in peripheral vascular procedures.
According to press release issued in December 2015 by Boston Scientific and posted on the website of the U.S. Food and Drug Administration (FDA), the company has received 14 separate reports of shaft separation, including four instances of separation of the distal shaft. The most severe risk associated with this failure is the embolism of device fragments, which could result in obstructed blood flow or the need for further intervention to remove a device fragment. However, as of the date of the recall, the company had not received any notices of injuries or deaths associated with the recalled sheaths.
The FDA has classified the action by Boston Scientific as a Class-1 recall, which is assigned in situations in which there is a reasonable probability of death or a serious adverse health consequence associated with the use of a given device.