What’s the problem?
The Chariot Guiding Sheath recall was issued November 19 after Boston Scientific received at least 14 complaints of shaft separation, including 4 involving the distal shaft. A total of 22 adverse event reports for the device are currently listed in FDA’s MAUDE database for 2015.
According to Boston Scientific, events typically occurred during device preparation for use; however, FDA notes that the possibility of separation and embolism of device fragments during could lead to obstruction of blood flow and additional interventions.
Physicians who have used the Chariot Guiding Sheath have been advised to check up on any patients in whom the device was used because “shaft separation and embolized fragments may not have been recognized at the time of the procedure,” according to the recall notice. Additionally, all healthcare facilities currently using these devices have been contacted and told to immediately discontinue use and return any unused products to the manufacturer.
Do I Have a Chariot Guiding Sheath Class Action Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Chariot Guiding Sheath Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one suffered an injury after undergoing a medical procedure with a Chariot Guiding Sheath, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.