Guiding sheath used in peripheral vascular procedures recalled

The FDA has designated a recall of a sheath used to introduce and/or guide the placement of interventional and diagnostic devices into peripheral veins and arteries as Class I, the most serious type of recall.

Bard Peripheral Vascular on Jan. 10 issued a recall of the sheath (Halo One Thin-Walled Guiding Sheath) because the sheath body may separate from the hub on removal from the patient’s leg, the sheath may kink or its tip may become damaged during the procedure. The FDA declared it a Class I recall on Jan. 30.

According to a notice issued by the FDA, use of the sheath may result in longer procedure times and additional intervention to remove separated parts and may cause serious adverse health consequences, such as internal tears and perforation to arteries or veins, excessive bleeding and death.

The lot numbers affected by the recall are 50137556, 50137557, 50137598 50137682 50137723, 50137735, 50137875, 50137965, 50138274, 50138119, 50138118, 50138122, 50138273, 50138435, 50138437, 50138701, 50138439, 50137570, 50137770, 50137979, 50138696, 50137866, 50137924, 50138170 and 50138765, according to the FDA.

The affected sheaths were distributed between June 24, 2016, and July 3, 2016.

When Bard Peripheral Vascular issued its recall notice, it asked consignees to stop using, or further distributing, any affected products; to check all inventory locations for affected products; to remove any affected products from the shelves; and to contact the firm’s recall coordinator. If an affected product had been used, consignees were instructed to complete the recall and effectiveness check form.