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FDA Classifies Recall Of Boston Scientific Device As “Most Serious”


The U.S. Food and Drug Administration recently issued a recall of a Boston Scientific medical device used to block blood flow during excessive bleeding or hemorrhaging, classifying the recall as “most serious.” The device, Obsidio Embolic, poses a higher risk of bowel ischemia when paired with a specific technique during gastrointestinal bleeding, according to the FDA.

Bowel ischemia occurs when blood flow to the intestines is decreased resulting in severe pain. The lack of blood flow can result in damage to the intestines which in turn results in prolonged hospitalization and the potential for death. The FDA said that the failure of the device resulted in 11 discrete incidents. Seven of those were injuries. Two deaths were related to the issue. The FDA said the recall is a correction and not a product removal.

Boston Scientific issued an advisory notice explaining that the use of the aliquot technique is not recommended with the Obsidio Embolic device when used for procedures treating lower GI bleeding.

Boston Scientific said that the device’s performance could be compromised when used with the aliquot technique. The company advises physicians not to use the technique during the procedure. Otherwise, Boston Scientific claims, the device remains safe for use as labeled.

Medical device lawsuits and product liability 

Medical device companies can be held accountable for the failure of their device resulting in death or injury. In the case of Boston Scientific’s Obsidio Embolic device, 7 injuries and 2 fatalities were reported. Medical device companies are strictly liable for the failure of their devices. That means that a plaintiff who suffered injury or a grieving family filing a wrongful death lawsuit would not have to prove that the company was negligent. In this case, it is sufficient for the plaintiff to establish that they were not warned about a potential danger related to the device. In terms of Obsidio Embolic, the device can fail when used with the aliquot technique. Doctors and patients should have been warned about this potential complication before the device was used on them. The company is responsible for anticipating potential problems that their device causes.

At present, the company is recalling the devices to ensure that the problem doesn’t continue. However, the recall doesn’t get them off the hook for injuries that their device caused or causes. Even after the recall, an injured party can sue the medical device company to recover damages related to their injuries. Additionally, a grieving family who lost a loved one due to the device’s failure could also file a wrongful death lawsuit if their loved one is killed.

Talk to a Florida Medical Device Liability Attorney Today 

Halpern, Santos & Pinkert represent the interests of Florida residents who have been injured by dangerous or defective medical devices. Call our Florida personal injury lawyers today to schedule a free consultation, and we can begin discussing your case right away.



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