Since being brought to market in 2014, two Vascu-Guard Patch recalls have been announced by Baxter International, Inc. The most recent recall was issued in 2016, and deemed a Class II by U.S. health regulators. Class II recalls involve products that may cause a temporary health problem, or pose a slight threat of a serious nature or death. A recall announced a year earlier was designated Class I, which indicates there is a reasonable probability that use of the affected devices will cause serious adverse health consequences or death.
Bernstein Liebhard LLP is now evaluating legal claims on behalf of patients who may have been injured by recalled Vascu-Guard Patch products. These devices have been linked to reports of blood clots, hematoma, embolisms, stroke, and death. If you or a loved one suffered serious complications that might be associated with a Vascu-Guard Peripheral Vascular Patch, please contact our Firm by calling (888) 994-5118 to ensure that your legal rights are protected.
The Vascu-Guard Patch received 510K clearance in November 2014 for use in peripheral vascular reconstruction and arteriovenous access revisions. The products are made from bovine pericardium (procured from cattle within the U.S.) and cross-linked with glutaraldehyde. The material is chemically sterilized using ethanol and propylene oxide.
In June 2016, Baxter International announced a Vascu-Guard Patch recall for the following sizes and product codes:
According to the company’s notification, the recall was prompted by reports of intraoperative or postoperative bleeding episodes, which required additional clinical intervention, including one with a fatal outcome.
In August, the U.S. Food & Drug Administration (FDA) issued a Letter to Healthcare Professionals warning that it had received multiple adverse event reports associated with the Vascu-Guard Patch when used in carotid endarterectomy (CEA) surgery. Reports from 2016 included incidents of severe bleeding, hematomas, and three patient deaths that could be associated with this issue. The FDA warned that arterial bleeding in the neck following a CEA procedure could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.
The FDA letter noted that the Vascu-Guard recall had been categorized as Class II. The agency said it was working with Baxter to determine if the recall action covered all lots that may have been associated with the reported problems.
In May 2015, Baxter International announced a Class I Vascu-Guard Patch recall for the following sizes and product codes:
The recall was initiated after Baxter received complaints from customers who had experienced difficulty in distinguishing the smooth from rough surface of the patch as described in the instructions for use. According to the FDA, Baxter reported 51 complaints related to this issue and one serious injury. If the rough side of the patch is implanted in the incorrect way, blood clots may form on the patch, potentially leading to embolism, reduced blood flow, stroke, organ failure, or death.
The Vascu-Guard recalls were just the latest in a string of safety issues involving Baxter products. According to a report from the Chicago Tribune, the company had issued five product recalls during 2015, including the first involving Vascu-Guard. That year, Baxter was also hit with four recalls for IV solutions due to problems that included insect contamination, leaking containers, particulate matter and missing port protectors. In fact, numerous recalls have been issued over the past several years, some of which have cost Baxter millions of dollars. Read More
Individuals who suffered complications that may be associated with a Vascu-Guard Patch recall could be entitled to compensation for any damages they may have incurred due to their injury. To arrange for a free, no-obligation legal review, please contact Bernstein Liebhard LLP by calling (888) 994-5118.
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