Halo One Thin-Walled Guiding Sheath Recall Attorney
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.
Reason for the Halo One Thin-Walled Guiding Sheath Recall
As stated by FDA, this device was recalled because the sheath body may separate from the sheath hub while the device is being removed from the patient’s leg. Also, the sheath may kink or the tip may become damaged during the procedure.
FDA reports that use of this device could result in:
- Prolonged procedure time
- Additional surgery to remove detached components from the patient
- Internal tears and perforation to the veins or arteries
- Excessive bleeding
- Death of the patient
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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Do You Have a Halo One Thin-Walled Guiding Sheath Lawsuit?
Goldberg & Rosen is one of the most prestigious law firms in Miami with a track record of outstanding case results. We believe that people should not have to suffer injuries from medical devices that were designed to improve their health. Our team of talented Miami attorneys is known for providing comprehensive legal assistance, protecting our clients’ rights, and winning the substantial settlements and verdicts our clients deserve.
If you or your loved one has been injured in a procedure in which this device may have been used, contact us to schedule a consultation with our product liability attorney. If this recalled device was used in your procedure, your medical records should contain that information. Our Halo One Thin-Walled Guiding Sheath lawyer can help you find out if you are eligible to file a lawsuit to recover compensation for your injuries.