Baxter International, Inc.’s Vascu-Guard Patch may be associated with severe bleeding and other potentially deadly complications. A Class II recall was issued for some of these devices in 2016, following reports of internal bleeding in patients who had undergone carotid endarterectomy (CEA) surgery with a Vascu-Guard Patch.
Federal health regulators have warned that the Vascu-Guard Peripheral Vascular Patch has been associated with reports of intraoperative or postoperative bleeding when used in CEA procedures. Bernstein Liebhard LLP is now offering free, no-obligation legal reviews to Vascu-Guard patients who may have suffered this and related complications, including hematoma, blood clots, embolism and stroke. To discuss filing a Vascu-Guard Patch lawsuit with a member of our legal team, please call (888) 994-5118.
In June 2016, Baxter International announced that it was voluntarily recalling specific lots of the Vascu-Guard Patch because of reports of intraoperative or postoperative bleeding and hematomas following CEA surgery. In August, the U.S. Food & Drug Administration (FDA) issued a Letter to Healthcare Providers indicating that it was investigating a cluster of bleeding cases that had occurred in 2016 among patients who had received a Vascu-Guard device during CEA, including three patient deaths potentially related to this issue.
CEA, or carotid endarterectomy, opens or cleans a blocked carotid artery (located in the neck) in order to prevent stroke. Once plaque has been removed from the artery, the blood vessel is repaired via a natural graft or a woven patch, such as Vascu-Guard. According to the FDA, arterial bleeding in the neck following CEA surgery can quickly lead to serious or life-threatening complications, including:
The FDA has designated the Vascu-Guard Patch recall a Class II recall, indicating that the affected products may cause a temporary health problem, or pose a slight threat of a serious nature or death. Doctors and Vascu-Guard Patch patients should watch for severe bleeding symptoms, including swelling and trouble breathing.
The Vascu-Guard recall involved the following sizes and product codes:
A complete list of affected lots can be accessed at the FDA’s website.
Individuals who may have suffered episodes of severe bleeding from a Vascu-Guard Patch could be entitled to compensation for injury-related damages. To contact a medical device attorney who can protect your legal rights, please call Bernstein Liebhard LLP at (888) 994-5118.
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