The U.S. Food & Drug Administration (FDA) has issued a Class 1 Recall for the Bard Halo One Guiding Sheath amid reports that the sheath body may separate from the stem hub during use, which could lead to serious injury or even death of the patient.
Free Confidential Lawsuit Evaluation: If you were injured by a guiding sheath, or someone you know died during a procedure in which one was used, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
Bard’s Halo One Thin-Walled Guiding Sheath is used to aid with placement of medical devices into veins and arteries through an incision made in a patient’s leg. According to an FDA Medical Device Recall Notice issued January 20, 2017, these guiding sheaths are being recalled because the sheath body may separate from the sheath hub while removing the device from a patient’s leg. “The company also reports that the sheath may kink, and that its tip may become damaged during the procedure,” FDA said.
Which Products are Affected?
The Bard Halo One Sheath recall affects the following products:
- 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
- Manufacturing Dates: April 12, 2016 to July 7, 2016
- Distribution Dates: June 24, 2016 to July 12, 2016
These products were distributed in the following states: Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, Washington.
Guiding Sheath Risks
Use of the above products may result in one or more of the following:
- Prolonged procedure times
- Need for additional surgery to remove detached components from the patient
- Internal tears and/or perforation of arteries or veins
- Excessive bleeding
Do I Have a Bard Halo One Sheath Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in guiding sheath lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you were injured by a guiding sheath, or someone you know died during a procedure in which one was used, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.