FDA: Class I recall of Bard Halo One Thin-Walled Guiding Sheath

Editor's Note

The Food and Drug Administration (FDA) on January 30 classified the recall by Bard Peripheral Vascular Inc (Tempe, Arizona) of its Halo One Thin-Walled Guiding Sheath as Class I, the most serious.

The recall was issued because the sheath body may separate from the sheath hub while removing the device from the patient. In addition, the sheath may kink, and its tip may become damaged during the procedure.

The sheath is used to introduce and guide the placement of interventional and diagnostic devices into veins and arteries through an incision in the patient’s leg.

The sheaths were distributed between June 24, 2016, and July 12, 2016.

The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.