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The Halo One Thin-Walled Guiding Sheath is a medical device used to introduce or guide the placement of diagnostic and interventional devices into the veins and arteries through an incision in the patient’s leg.


The Food and Drug Administration (FDA) has announced that Bard Peripheral Vascular Inc., the manufacturer of this device, initiated a recall on December 2, 2016. The company issued a Medical Device Recall Notification on January 10, 2017, instructing consignees to stop using and distributing this product and to remove it from the shelves. At Goldberg & Rosen, our dedicated legal team is proud to represent individuals who have been injured by dangerous medical devices.

For more than 40 years, our top Miami lawyers have been fighting large corporations and insurance companies to obtain justice for the clients we serve. If you or someone you love has been seriously injured by the Halo One Thin-Walled Guiding Sheath, we may be able to assist you in a lawsuit against the manufacturer to recover compensation for the losses you have suffered.

This recall has been identified by FDA as a Class I recall, the most serious recall type. FDA has stated that use of this device may cause serious injuries or death. It applies to products manufactured from April 12, 2016, to July 7, 2016, and distributed June 24, 2016, to July 12, 2016.

In the U.S., the recalled devices include 101 units distributed in 14 states – Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, and Washington.

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If you or a loved one have been the victim of negligence or misconduct, please do not hesitate to contact among the best attorneys Miami has available at Goldberg & Rosen today to receive expert guidance about your legal options, as well as a free and confidential case evaluation.

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