Bard recalled the Halo One Guiding Sheath because it can break off in a patient’s body, slice open a vein, require emergency surgery, or cause deadly bleeding.
Need a Texas Halo One Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by a recalled Bard Halo One Guiding Sheath, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Bard Peripheral Vasculature Inc. manufactures the Halo One Thin-Walled Guiding Sheath. It is a tool used in diagnostic and interventional procedures to guide the placement of other devices into veins and arteries through an incision in the patient’s leg.
Halo One Recall
On January 10, 2017, Bard sent recall notices to warn doctors and patients about life-threatening risks of using certain Halo One Guiding Sheaths. The FDA designated it a Class I recall, the most serious type, reserved for devices that can cause death.
What is the Problem?
Complaints of sheath separation, kinking, and/or tip damage during use have been reported. The sheath body can break off from the sheath hub when it is being pulled out of the patient’s leg. The sheath may kink in a vein, and its tip can be damaged during the procedure.
Complications & Health Risks
- Delayed or lengthy medical procedures
- Imaging CT scans to locate broken pieces
- Emergency surgery
- Laceration or perforation of veins and arteries
- Excessive bleeding
- Internal bleeding from torn blood vessels
How is the Halo One Used?
Halo One is designed to perform as both a guiding sheath and introducer sheath. It is used in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices — but NOT the neurovasculature or coronary vasculature.
Recalled Product Information
The recall involves 101 units of the Halo One Thin-Walled Guiding Sheath that were manufactured between April 12, 2016 and July 7, 2016 and sold in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, Washington.
- Product Codes: HAL545, HAL590 HAL510F
- Lot Numbers: 50137556, 50137557, 50137598 50137682 50137723, 50137735, 50137875, 50137965, 50138274, 50138119, 50138118, 50138122, 50138273, 50138435, 50138437, 50138701, 50138439, 50137570, 50137770, 50137979, 50138696, 50137866, 50137924, 50138170, 50138765
Need a Halo One Recall Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Halo One recall lawyers for a free lawsuit review.