The Bard Halo One Guiding Sheath was recalled due to the risk of it breaking off inside a patient’s body and causing serious vein injuries, emergency surgery, excessive bleeding, or death.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Bard Halo One Sheath induced injury cases in all 50 states. If you or somebody you know had an interventional procedure injury or death, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is the Bard Guiding Sheath?
The Halo One Thin-Walled Guiding Sheath (Halo One) is a tool that guides other devices into veins and arteries through an incision in the patient’s leg. It is used during diagnostic or interventional procedures.
Halo One Guiding Sheath Recall
Bard recalled the Halo One because the sheath can break off inside the patient when it is being pulled out. Bard also reports that the sheath can kink, and that the tip can be damaged during a procedure.
Health Risks & Complications
- Procedure will take longer
- Emergency surgery to remove broken pieces
- Lacerating veins and arteries
- Internal tears or perforations
- Excessive bleeding
- Death
FDA Warning: Class 1 Recall
The FDA has issued a Class I recall, the most serious type of recall, and warns doctors that using a recalled Bard Halo One Guiding Sheath could cause severe injuries or death.
Recalled Product Information
The recall involved Halo One Thin-Walled Guiding Sheaths manufactured by C.R. Bard between April 12, 2016 and July 7, 2016. Approximately 101 units are affected by the recall.
They were 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
How is the Product Used?
Halo One is designed to work as a guiding sheath or as an introducer sheath. It is approved by the FDA for peripheral arterial and venous procedures that require the placement of intravascular devices through percutaneous incisions. However, it is not approved for use in the neurovasculature or coronary vasculature (veins in the heart or brain).
Not Sure If You Were Injured?
Even if you are not sure if the Bard Halo One was used in your surgery, contact our lawyers. This information should be in your medical records. Our lawyers may be able to help you find out if you qualify to file a lawsuit.
Do I have a Halo One Lawsuit?
The Schmidt Firm, PLLC is currently accepting Bard Halo One Sheath induced injury cases in all 50 states. If you or somebody you know had an interventional procedure injury or death, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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