FDA Warns of Class I Recall of Chariot Guiding Sheath Used in Peripheral Procedures


Boston Scientific has issued a worldwide recall of its Chariot Guiding Sheath, used in peripheral vascular interventions, FDA’s Medwatch program announced today. The recall was issued after the company received 14 complaints of shaft separation, including 4 involving the distal shaft, a Boston Scientific press release notes. A total of 22 adverse event reports for the Chariot are currently listed in FDA’s MAUDE database for 2015.

The company issued its recall on November 19, 2015. The FDA designated the action as a Class I recall, meaning the problem can lead to death or serious injury.

Events, according to the company, typically occurred during device preparation for use, but the FDA notes that the possibility of separation and embolism of device fragments during a procedure could lead to obstruction of blood flow and additional interventions.

Physicians who have used the device are being urged to check up on any patients in whom the Chariot was used because “shaft separation and embolized fragments may not have been recognized at the time of the procedure,” the recall notice reads. In addition, all healthcare facilities currently using these devices have been contacted and told to immediately discontinue use of the affected devices and to return any unused devices to Boston Scientific.

Operators who suspect they have used a device that has malfunctioned should report the case to MedWatch. 



Source:
Food and Drug Administration. Chariot Guiding Sheath by Boston Scientific: Recall - Risk of Shaft Separation. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm476848.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Published on: December 11, 2015. Accessed on: December 11, 2015.

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