Boston Scientific Obsidio Embolic Device Classified as Class I Recall By the FDA

The U.S. Food and Drug Administration (FDA) has taken a significant step by classifying the recall of Boston Scientific’s device used to block blood flow during excessive bleeding or hemorrhaging as the “most serious” category. This move follows an investigation revealing that Boston’s device, Obsidio Embolic, when utilized with a specific technique, poses a heightened risk of bowel ischemia during procedures aimed at stopping gastrointestinal (GI) bleeding.

Bowel ischemia refers to disorders that occur when blood flow to the intestines decreases, resulting in severe abdominal pain. The limited blood flow may lead to prolonged hospitalization or, in severe cases, death, as highlighted by the FDA. The health regulator has reported 11 incidents related to this issue, including seven injuries and two deaths, underlining the urgency of addressing this safety concern.

While the recall is categorized as a correction rather than a product removal, it underscores the potential risks associated with the use of Boston Scientific’s Obsidio Embolic device in specific medical procedures. Boston Scientific issued an advisory notice on Feb. 21, advising against the use of the aliquot technique with Obsidio Embolic during procedures treating lower GI bleeding. The company emphasized that the device’s performance could be compromised when used with the aliquot technique, urging physicians to refrain from its use during such procedures.

Despite the safety concerns raised by the recall, Boston Scientific maintains that the device remains safe for use as labeled and continues to be available for the treatment of internal bleeding and hemorrhaging. However, for individuals who have suffered injuries or loss due to the use of Obsidio Embolic, understanding their legal options and seeking recourse for damages is essential.

Filing For Compensation

Victims of device-related injuries may be entitled to file a product liability lawsuit against Boston Scientific, seeking compensation for their injuries, medical expenses, lost wages, pain and suffering, and other losses incurred as a result of the defective device. The lawsuit process involves several critical steps, each requiring careful consideration and legal expertise to navigate effectively.

Firstly, victims need to consult with experienced attorneys specializing in product liability law to evaluate the merits of their case and determine the best course of action. Attorneys play a crucial role in conducting a comprehensive investigation into the circumstances surrounding the injuries, gathering evidence, and building a strong case against the manufacturer.

Throughout the litigation process, attorneys advocate on behalf of their clients, representing their interests in negotiations with the manufacturer and presenting their case in court if necessary. Attorneys work tirelessly to secure a favorable outcome for their clients, whether through settlement negotiations or trial verdicts.

In cases where settlements cannot be reached, attorneys prepare for trial, presenting evidence and arguments to a judge and jury to prove the manufacturer’s liability and obtain fair compensation for the victim’s injuries. With the guidance and advocacy of skilled attorneys, victims of device-related injuries can seek justice and hold negligent manufacturers accountable for their actions.