The FDA has identified the Bard Halo One recall as Class I, the most serious type of recall. The FDA is warning health professionals and patients that use of these devices may cause serious injuries or death.
Can I sue Bard for injury or wrongful death caused by the Halo One Thin-Walled Guiding Sheath?
Yes, it is possible you may have the right to sue Bard Peripheral Vascular Inc. (Bard) for injury or wrongful death associated with use of the company’s Halo One Thin-Walled Guiding Sheath (Halo One) during a diagnostic or interventional procedure.
The Halo One Thin-Walled Guiding Sheath is used to aid surgeons, interventional radiologists and other doctors with placement of interventional and diagnostic devices into veins and arteries through an incision made on a patient’s leg. The risk with these products, and the reason for the product recall, is that the sheath body may separate from the sheath hub while removing the device from the patient’s leg. “The company also reports that the sheath may kink, and that its tip may become damaged during the procedure,” according to the FDA.
What if I am not sure if a Bard Halo One was Used during a procedure?
The medical records should indicate if a Halo One guide sheath was used. You can discuss this with one of our lawyers as part of your free consultation. Our attorneys for these cases are Fred Pritzker, Brendan Flaherty and David Szerlag (of Counsel). They are our team that won $45 million for clients injured by another product made by another health product manufacturer.
Bard Halo One Recall Information
The Halo One Thin-Walled Guiding Sheath is the product being recalled. Below is additional information from the FDA.
- 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
- Devices Recalled in the U.S.: 101 units distributed in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, Washington.
On January 10, 2017, Bard sent a Medical Device Recall Notification, which instructed consignees to, among other things:
- Stop using, or further distributing, any affected products
- Check all inventory locations for affected product codes and lot numbers
- Remove any affected products from the shelves.
What are the risks associated with use of this product?
The use of affected sheaths may result in any of the following:
- prolonged procedure times
- the need for additional surgical intervention to remove detached components from the patient
- internal tears and perforation to arteries or veins
- excessive bleeding
If the patient survives, he or she may have a personal injury claim against Bard. If the patient does not survive, the family may have a wrongful death claim against the company.
What about a class action lawsuit against Bard for harm from the Halo One?
It is important that you talk to our lawyers about this. Fred, Brendan and David are available to answer your questions. You can contact them here.
Class action lawsuits are generally not appropriate for cases where a medical product causes severe injury and wrongful death. Instead, individual lawsuits would be filed. In some cases, the pre-trial procedures are done by a panel of lawyers who have filed several individual lawsuits. This is done with multidistrict-litigation (MDL) proceedings.
Pritzker Hageman Law Firm
Pritzker Hageman, P.A. helps patients injured by medical products and the families of patients who do not survive. Our clients have product liability claims against large medical device and pharmaceutical companies. In some cases, our clients also have medical malpractice claims. Each client and each case is unique.
Our law firm has won multimillion-dollar against national companies doing business in all 50 states: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wyoming.