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Boston Scientific’s Chariot Guiding Sheaths Under FDA Class 1 Recall over Risk of Shaft Separation

Filed December 14th, 2015 Fran Kelley

Boston Scientific, the manufacturer of Chariot Guiding Sheath, a device used in peripheral vascular procedures, has initiated a worldwide recall of the devices because of the risk of shaft separation, which could cause patient injury or death.

The recall was initiated on November 19, 2015 and affects all lot numbers of the Chariot Guiding Sheaths. A full list of lots numbers can be found on the FDA web site.

The recalled Chariot Guiding Sheaths are used to introduce interventional devices during peripheral vascular procedures—procedures to relieve blockage of an artery in the arm or leg. To date, Boston Scientific has received fourteen complaints of shaft separation, four of which involved separation of the distal shaft. No permanent injuries or patient have been reported.

The separations occurred during device preparation or use. According to the FDA, 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 injuries such as stroke, kidney damage or damage to the intestines or limbs.

The FDA has designated this a Class 1 recall. Class 1 is the most serious recall category and is used in 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 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 Guiding sheaths 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 may direct questions either to their Boston Scientific representative or directly to the company at 1-800-811-3211.



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