A Chariot Guiding Sheath lawsuit may follow a recall of Boston Scientific’s Chariot Guiding Sheath. The peripheral vascular device is used to place interventional and diagnostic devices into a patient’s veins and arteries of the arms, legs, hands, or feet. The U.S. Food and Drug Administration (FDA) designated the recall as Class I, indicating that these medical devices may cause serious injuries or even death, defective medical device attorneys note.
If you or a loved one suffered a serious injury following a procedure in which a Chariot Guiding Sheath may have been involved, contact Attorney Group for more information about your options. We can answer your questions in a free, confidential, no-obligation consultation, and if you wish to pursue a claim, we can connect you with an affiliated defective medical device lawyer who can assist you through the legal process.
What are Chariot Guiding Sheath Devices?
Chariot Guiding Sheaths are sold by the Boston Scientific Corporation. Doctors use the guiding sheath in minimally invasive procedures. The device is inserted into the patient’s blood vessels so that other, thinner tools can slide through it and can be easily directed to disease sites. The FDA gave Boston Scientific clearance to sell the Chariot Guiding Sheath in June, 2015. On November 19, 2015, Boston Scientific informed doctors and hospitals that they should immediately stop using Chariot sheaths. The company had received reports of shaft separation, including cases where the separation occurred on the end inserted into the patient’s body.
Chariot Guiding Sheath Recall
The December 2015 FDA Class I recall of the Chariot Guiding Sheaths involves Boston Scientific’s total global supply of 7,000 devices. The recall comes after reports of the shaft of the device separating, potentially causing small pieces of the device to break off and obstruct blood flow.
This may cause serious injury to a patient including:
- Stroke
- Kidney damage
- Injury to the intestines or limbs
- Additional surgery
- Death
The recalled material numbers (UPN) associated with the Chariot Guiding Sheath devices may be found here. Boston Scientific has received 14 reports of the Chariot Sheath malfunctioning and the shaft of the device separating. The FDA press release of the recall states the following:
“All affected healthcare facilities were previously advised to immediately discontinue use of affected devices and return unused Chariot Guiding Sheaths to Boston Scientific. Additionally, physicians are encouraged to contact all patients who have undergone procedures involving Chariot to confirm their post-procedure status, as device shaft separation and embolized fragments may not have been recognized at the time of the procedure.”
Injured Patients May Be Entitled to Compensation
Device makers have a duty to design and produce safe products, and to warn of possible risks associated with their products. Failure to fulfill that duty can result in injuries to patients, and the device maker being held liable for those injuries.
Patients who are injured by defective medical devices may be entitled to compensation for damages resulting from injuries. Compensation can be based on factors including:
- Medical expenses
- Lost wages
- Ability to work
- Pain and suffering from an injury
If a loved one dies from complications with a defective medical device, his or her family members may be able to pursue claims for wrongful death damages, which include:
- Pain, suffering, and mental anguish resulting from the loss of a loved one
- Conscious pain and suffering of a loved one prior to death
- Loss of financial support
- Medical expenses attributable to the fatal injury
Affected patients should speak to a defective medical device lawsuit attorney to learn more about the rights and remedies.
Contact Us For More Information
If you have been injured by a defective medical device, or for more information about a possible Chariot Guiding Sheath Lawsuit, contact Attorney Group for more information. You can fill out the form on this page, call us at the number listed at the top of the page, or email us at info@attorneygroup.com.
When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim for an injury. If you think you have a case, you should not delay taking action.
See our Frequently Asked Questions page for more information, and contact Attorney Group today.