FDA Announces Recall of Bard’s Halo One Peripheral Vascular Guiding Sheath
The sheath body may separate from the sheath hub while removing it from a patient, according to the manufacturer.
Yesterday the US Food and Drug Administration (FDA) announced a Class I recall for the low-profile, thin-walled peripheral guiding sheath known as Halo One. Device manufacturer Bard Peripheral Vascular initiated the recall on the sheaths in December 2016 and began notifying healthcare professionals and distributors earlier this month to stop using them.
The reason for the recall is potential separation of the sheath body from the sheath hub, which can occur while removing the device from a patient's leg. There is also concern that the sheath may kink and that its tip may become damaged during a procedure.
The FDA says use of affected sheaths could prolong procedure times and result in “additional surgical intervention to remove detached components from the patient.” The recall is a Class I—the most serious type—due to a potential for serious adverse health consequences, including internal tears and perforation of arteries or veins, excessive bleeding, and death.
The 101 recalled units were distributed from June 24 to July 12, 2016, in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, and Washington.
Physicians should report any adverse events they experience using the guiding sheaths to the FDA through the MedWatch safety information and reporting system.
US Food and Drug Administration. Bard Peripheral Vascular Inc. recalls Halo One thin-walled guiding sheath due to sheath separation, kinking, or tip damage. www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm538821.htm. Published on: January 30, 2017. Accessed on: January 31, 2017.