Boston Scientific is recalling its global supply of 7,000 Chariot Guiding Sheaths because parts of the device can break off during medical procedures and obstruct blood flow, which can result in injuries including stroke, kidney damage and damage to the intestines or limbs.
Free Confidential Lawsuit Evaluation: 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 suit against the manufacturer and our lawyers can help.
What is the Chariot Guiding Sheath?
Approved by the U.S. Food & Drug Administration (FDA) on June 5, 2015, the Chariot Guiding Sheath is used to introduce interventional devices during peripheral vascular procedures into the veins and arteries of a patient’s arms, hands, legs or feet (peripheral vasculature). The device was supposed to be substantially equivalent to an earlier model, the Terumo Pinnacle Destination sheath, which was approved in 2009.
What’s the Problem?
The FDA issued a Class I Recall for the Chariot Guiding Sheath after it was linked to at least 14 reports of shaft separation, including 4 cases where the separation happened on the end inserted into patients’ bodies. Class 1 recalls involve devices that can lead to serious health consequences or death.
Guiding sheath separation can cause small pieces of the device to break off and enter the patient’s bloodstream. This can obstruct blood flow and require additional medical procedures to remove device fragments. Obstructed blood flow can result in serious patient injury including stroke, kidney damage, damage to the intestines or limbs or death.
Which Devices are Affected by the Recall?
On December 15, Boston Scientific sent an urgent medical device recall removal letter to its customers advising them to immediately stop using and quarantine any and all affected products, which include:
This recall includes 5,692 units nationwide. The devices were manufactured from March 17, 2015 to November 10, 2015, and distributed from June 6, 2015 to November 17, 2015.
Do I Have a Guiding Sheath 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 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 were injured by 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.