Halo One Thin-Walled Guiding Sheath Recall Lawsuit | Bard Halo One Thin-Walled Guiding Sheath Side Effects

Halo One Thin-Walled Guiding Sheath Recall Lawsuit | Bard Halo One Thin-Walled Guiding Sheath Side Effects

Bard Thin-Walled Guiding Sheath Recall Lawsuit | Bard Thin-Walled Guiding Sheath Side Effects Lawsuit | Halo One Thin-Walled Guiding Sheath Side effects, Halo One Thin-Walled Guiding Sheath Internal tears, Halo One Thin-Walled Guiding Sheath artery tear, Halo One Thin-Walled Guiding Sheath artery Perforation, Halo One Thin-Walled Guiding Sheath vein tear, Halo One Thin-Walled Guiding Sheath vein Perforation, Halo One Thin-Walled Guiding Sheath Excessive bleeding, Halo One Thin-Walled Guiding Sheath Death

Bard Halo One Thin-Walled Guiding Sheath Lawsuit Side EffectsRecalled: Bard Peripheral Vascular Inc. Halo One Thin-Walled Guiding Sheath – Bard Peripheral Vascular Inc. has issued a recall of 101 Halo One Thin-Walled Guiding Sheaths because the device can potentially separate from the sheath hub while removing it from a patient’s leg. Bard Peripheral Vascular, a division of C.R. Bard, Inc., also announced that the sheath may kink, and that its tip may become damaged during a procedure. Use of the recalled sheaths could lead to prolonged procedure times or additional surgical intervention to remove detached components from a patient. The Halo One Thin-Walled Guiding Sheath may cause other serious adverse health consequences that include internal tears and perforation to arteries or veins, excessive bleeding, and death.
[fda.gov/MedicalDevices/Safety/ListofRecalls/ucm538821.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery, January 30, 2017]

Bard’s Halo One Thin-Walled Guiding Sheath Class 1 Recall

The U.S. Food and Drug Administration (FDA) has identified this as a Class 1 recall – the FDA’s most serious type of recall – because “use of these devices may cause serious injuries or death.” Bard Peripheral Vascular Inc. initiated the recall on December 2, 2016 and sent an Urgent Medical Device Recall Notification letter on January 10, 2017 directing healthcare facilities and distributors to stop using the products and remove them from the shelves.

The recalled guiding sheaths have products codes of HAL545, HAL590, and HAL510F, and were manufactured between April 12, 2016 to July 7, 2016. The affected devices were distributed from June 24, 2016 to July 12, 2016 in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, and Washington.
[fda.gov/MedicalDevices/Safety/ListofRecalls/ucm538821.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery, January 30, 2017]

Halo One Thin-Walled Guiding Sheath Side Effects


Side effects associated with Bard’s Halo One Thin-Walled Guiding Sheath include:

  • Parts left in body
  • Internal tears of arteries
  • Perforation of arteries
  • Internal tears of veins
  • Perforation of veins
  • Excessive bleeding
  • Death

Halo One Thin-Walled Guiding Sheath Recall Lawsuit Evaluations

Southern Med Law is investigating claims over Bard Peripheral Vascular Inc.’s Halo One Thin-Walled Guiding Sheath. If you have been harmed by a malfunctioning sheath or another medical device, you may be eligible to file a claim. Given Southern Med Law’s experience on many medical device injury cases, the firm knows how to best handle your case. To speak to one of the firm’s Bard Halo One Thin-Walled Guiding Sheath recall lawsuit attorneys, please call 205-547-5525 or visit www.southernmedlaw.com and fill out the online form.

The FDA and Halo One Thin-Walled Guiding Sheath

Bard’s Halo One Thin-Walled Guiding Sheath received clearance from the FDA through the regulatory agency’s 510k process. Under this process, the FDA does not require human clinical testing if medical device manufacturers can prove that their devices are substantially equivalent to another legally marketed device. The guiding sheath is used to guide the placement of interventional and diagnostic devices into veins and arteries through an incision made on a patient’s leg, according to the FDA.
[accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161183]

Recalled Product: Halo One Thin-Walled Guiding Sheath

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

[fda.gov/MedicalDevices/Safety/ListofRecalls/ucm538821.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery, January 30, 2017]

C.R. Bard Involved In IVC Filter Lawsuit Litigation

Court documents show that C.R. Bard is currently involved in multiple IVC Filter lawsuits in multidistrict litigation (MDL) over its Recovery Inferior Vena Cava (IVC) filters and G2 IVC filters that are used to trap blood clots and prevent them from reaching the lungs. The company is defending itself against 1,300 IVC filter lawsuits pending in the federal district court in Arizona. The IVC filter lawsuit claims commonly allege that Bard failed to adequately warn that its IVC filters can migrate, break, puncture the heart and lungs, and cause other serious injuries or death to implant patients. (Bard IVC Filter lawsuit Case Number – In Re: Bard IVC Filter Lawsuits – MDL No. 2641)

About Southern Med Law And Filing A Bard Halo One Thin-Walled Guiding Sheath Lawsuit

Throughout his career, Dr. Francois Blaudeau, founding member of Southern Med Law and practicing physician has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective advocate for those who were harmed due to negligent pharmaceutical manufacturers. If you or a loved one have been injured by a Bard Halo One Thin-Walled Guiding Sheath, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation Bard Halo One Thin-Walled Guiding Sheath lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.