Bard Peripheral Vascular issued a voluntary recall of its Halo One Thin-Walled Guiding Sheath over structural issues with the device, according to a Food and Drug Administration report.
The sheath is intended to guide the placement of interventional and diagnostic devices into veins and arteries through an incision in a patient's leg.
The devicemaker issued the recall after discovering the sheath body can separate from the sheath hub when clinicians remove the device from a patient's leg, which can result in longer procedure times or require a second surgical intervention to remove detached components of the device from the patient.
The FDA said the affected product can cause serious adverse health consequences including internal tears, perforation to arteries or veins, excessive bleeding and death.
Bard Peripheral Vascular sent a device recall notification to clinicians Jan. 10, instructing them to check sheaths for affected product codes and lot numbers and stop using any device involved in the recall.
To view affected lot numbers of the sheath, click here.
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