A Rotablator Guidewire lawsuit may follow a recall by the U.S. Food and Drug Administration (FDA) of Rotawire Elite Guidewire and wireClip Torquer Guidewire components that are used with the Rotablator Rotational Atherectomy System. The devices are used to open narrowed arteries and improve blood flow to the heart. The Class I recall indicates that these devices may cause serious injuries or death, defective medical device attorneys note.
If you or a loved one suffered a serious injury following a procedure in which a Rotablator Guidewire 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 Rotablator Guidewire Devices?
Rotablator Guidewires are used to open narrowed arteries and improve blood flow to the heart by cutting plaque from the artery wall. The Rotawire Elite Guidewire and wireClip Torquer Guidewire are manufactured by Boston Scientific Corporation and are components of the Rotablator Rotational Atherectomy System.
The recalled Rotawire Elite Guidewire and wireClip Torquer Guidewire devices sold with the Rotablator Rotational Atherectomy Systems were manufactured from June 2015 through September 2015, and sold to healthcare professionals in 17 states from July 2015 through October 2015. The FDA reports that roughly 600 units were manufactured and sold on the market.
Rotablator Guidewire Recall
The October 2015 recall of the Rotablator Guidewire announced by the FDA comes after reports of the device cracking and separating from the rest of the Rotablator Rotational Atherectomy System.
This may cause serious injury to a patient including:
- Tamponade (blood in the sac around the heart causing decreased heart function)
- Myocardial infarction (heart attack)
- Migration of wire fragments elsewhere in the body
The FDA emphasized the seriousness of the recall by stating:
“The use of the affected product may cause serious adverse health consequences, including death.”
The following are the recalled material numbers (UPN) associated with the Rotawire Elite Guidewire and wireClip Torquer Guidewire Manipulation Devices:
- H802223301
- H802223300
- H802233301
- H802233300
Boston Scientific has received three reports of the device malfunctioning, including one death following medical intervention to remove the broken wire. Other emergency procedures as a result of the defective device have included purposefully blocking off the affected artery, placing stents into the affected artery, and emergency heart surgery.
Is a Rotablator Guidewire Lawsuit an Option?
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 their rights and remedies and options for pursuing a Rotablator Guidewire lawsuit.
To learn more about a possible Rotablator Guidewire lawsuit, contact Attorney Group for more information.
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.
