Class I recall issued because medical device may disintegrate inside arteries
The Food and Drug Administration (FDA) recently issued a Class I medical device recall for Boston Scientific’s Rotawire Elite Guidewire and wireClip Torquer Guidewire over concerns the devices may fall apart while inside a patient’s arteries. The medical device is a long, flexible cable used to scrape plaque from artery walls in a procedure known as an atherectomy.
According to the FDA Rotawire Elite Guidewire recall, if the device cracks, metal fragments may migrate through the arteries. Serious injuries such as tamponade (blood in the sac around the heart causing decreased heart function) and heart attack may result from undergoing procedures utilizing the Rotawire Elite Guidewire.
Class I recalls are the most serious type of recall issued by the FDA. Regulators will designate a medical device for Class I status if the device poses a risk of serious injury or death. The FDA reports at least one person died after surgery to remove fragments left from a Boston Scientific Rotawire Elite Guidewire.
The FDA reports other procedures performed to mitigate serious adverse events with Boston Scientific Rotawire Elite Guidewires include purposely blocking arteries, the placement of valve stents, and emergency heart surgery. The FDA warns continued use of the device may result in adverse health consequences, including death.
Boston Scientific Rotawire Elite Guidewires were used in 17 states, including Maryland. If you or a loved one suffered a serious Boston Scientific Rotawire Elite Guidewire injury, the experienced attorneys of The Cochran Firm, D.C. can help. Injury victims harmed by defective medical devices may be eligible to recover medical expenses, hospital bills, lost wages, pain and suffering, and other damages.
Our law firm’s attorneys serve Maryland, Washington, D.C., and Virginia. We represent our clients on a contingency basis, meaning there are no upfront legal costs and we only collect our fee if we win your case. Contact us for a free legal consultation to see if you have an actionable claim.