The recall was prompted due to reports that the sheath body may separate from the sheath hub while removing the device from the patient's leg. The company also reports that the sheath may kink, and that its tip may become damaged during the procedure.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The Halo One Thin-Walled Guiding Sheath is used to introduce and/or guide the placement of interventional and diagnostic devices into veins and arteries through an incision made on a patient's leg.
The use of affected sheaths may result in prolonged procedure times and on additional surgical intervention to remove detached components from the patient. The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
The sheaths that have been recalled were distributed in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, Washington, between June 24, 2016 to July 12, 2016. They were manufactured between April 12, 2016 to July 7, 2016.