Urgent Recall of Halo One Thin-Walled Guiding Sheath
Bard Peripheral Vascular, Inc. has initiated an urgent recall of its Halo One Thin-Walled Guiding Sheath. Because of the risk that this medical device will cause significant adverse health consequences or death, the FDA has identified this as a Class I recall, which is the most serious type of recall.
The Halo One device is intended to be used to introduce and/or guide the placement of medical devices into a patient’s veins and arteries. Bard, however, reports that the Halo One’s sheath may unintentionally separate, kink, and/or become damaged during procedures. Such problems may result in prolonged procedure times, additional procedures to remove damaged parts of the Halo One device, internal tears and perforation of arteries and veins, excessive bleeding, and death.
If you or a loved one suffered injuries that you believe were caused by a Bard Peripheral Vascular, Inc.’s Halo One Thin-Walled Guiding Sheath contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.