The FDA has announced a Class 1 recall for Bard’s Halo One thin-walled guiding sheath over problems associated with sheath separation, kinking and tip damage during use.

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.

bard-halo-one-sheath

What’s the Problem?

According to an FDA Medical Device Recall Notice issued on January 30, 2017, C.R. Bard is recalling its Halo One Thin-Walled Guiding Sheath amid reports that the sheath body can separate from the sheath hub while removing the device from the patient’s leg. The company also reported that the sheath can kink, and that its tip may become damaged during the procedure, which can lead to serious injury or even death.

Guiding Sheath Risks

Halo One Guiding Sheath malfunctions may result in:

  • Prolonged procedure times
  • Additional surgery to removed detached components from the patient
  • Internal tears and perforations of arteries and veins
  • Excessive bleeding
  • Death

Which Products are Being Recalled?

The recall affects Halo One thin-walled guiding sheaths with product codes HAL545, HAL590 and HAL510F, manufactured between April 12, 2016 and July 7, 2016 and distributed between June 24, 2016 and July 12, 2016.

A total of 25 different lot numbers were named in the recall (see recall notice for specific numbers), with 101 devices distributed in the following states: Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah and Washington.

Can I Participate in a Class Action?

Although we are a nationally recognized class action firm, the Medical Device Liability Litigation Group at our law firm has decided against the filing of a Bard Halo One Sheath Class Action Suit, and is currently only filing individual complaints on behalf for people who have been injured or suffered wrongful death because of the device. Our lawyers known that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual Bard Halo One Sheath lawsuits on their behalf.

Do I Have a Bard Halo One Sheath Lawsuit?

The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in guiding sheath recall 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.

FREE Confidential Case Evaluation

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 588-0600.

*
*
*