Bard Peripheral Vascular recalled 101 of its Halo One Thin-Walled guiding sheaths, which are used to introduce and/or guide interventional and diagnostic devices into veins and arteries.
The FDA announced the recall in a news release on Jan. 30. Bard found that the sheath body could separate from the sheath hub when clinicians remove the device from patients’ legs. The company also said the sheath could kink and the tip could become damaged.
Bard sent a recall notification to customers on Jan. 10 telling them to stop using and distributing the affected products. The recalled products were manufactured from April 12 to July 7, 2016, and were distributed from June 24 to July 12, 2016.
The 101 devices recalled were distributed in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah and Washington.