FDA issues Class I Recall on Bard Halo One Thin-Walled Guiding Catheters
Bard Peripheral Vascular has recalled 101 of its Halo One Thin-Walled Guiding Sheaths, used to introduce and/or guide the placement of interventional and diagnostic devices into arteries and veins.
The U.S. Food and Drug Administration announced the class I recall, the most serious of its kind, in a Jan. 30 safety alert.
Bard officials said that the sheath body may separate from the sheath hub while removing the device from the patient's leg. The device manufacturer also found that the sheath may kink and its tip may become damaged during the procedure.
"The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death," according to a FDA statement.
Use of affected sheaths may also prolong procedure times and possibly require an additional surgical intervention to remove detached components from the patient.
The recall affects 101 units distributed between June 24, 2016, and July 12, 2016, in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah and Washington. Specific lot numbers are available in the recall notice.
Bard Peripheral sent a voluntary recall notice on Jan. 10, instructing customers to stop using and distributing any affected products.
Healthcare professionals are encouraged to report adverse events or side effects related to the use of the device to the FDA's MedWatch Safety Information and Event Reporting Program at accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
Jeffrey H. Miller, MD
Jeffrey H. Miller, MD, is the founder and CEO of Miller Vein, with five locations in Southeast Michigan. Dr. Miller has received numerous awards and honors in his field, including being named one of Hour Detroit Magazine’s “Top Docs.” His multi-site company has received numerous accolades including Coolest Place to Work by Crain’s Business Detroit, Novi Chamber of Commerce’s Customer Service Excellence Award and several Corp! Michigan’s Economic Bright Spots Awards.