The Murray Hill, N.J.-based company’s Halo One sheath is designed to introduce and guide the placement of interventional or diagnostic devices into veins and arteries through an incision on the patient’s leg.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The federal watchdog said Bard is recalling the device over issues with the sheath body which result in it separating from the sheath hub while removing the device from the patient’s leg. The company also reported that the sheath can kink, and that its tip may become damaged during the procedure, which could cause adverse health consequences.
Such malfunctions could result in prolonged procedure times or additional surgical interventions to removed detached components from the patient. The agency warned that affected products could cause other serious adverse health consequences, including internal tears and perforations of arteries and veins, excessive bleeding and death.
The recall affects Halo One thin-walled guiding sheaths with product codes HAL545, HAL590 and HAL510F, manufactured between April 12, 2016 and July 7, 2016 and distributed between June 24, 2016 and July 12, 2016. A total of 25 different lot numbers were named in the recall, with 101 devices distributed in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah and Washington.
Bard said it began notifying customers with the devices on Jan. 10, instructing them to remove affected unused products to return the items.