It was a rough summer for Baxter International, Inc., which was forced to issue its second recall for the Vascu-Guard Peripheral Vascular Patch. Unfortunately, it appears that the Vascu-Guard Patch recall was only the latest safety issue to ensnare the company in recent years.
In January, the Chicago Tribune reported that Baxter had issued five product recalls during the previous year. Those actions included an earlier, Class I recall for 15 lots of the Vascu-Guard Patch, as well four recalls of IV solutions for issues that included insect contamination, leaking containers, particulate matter and missing port protectors.
“For Baxter, recalls are an ongoing issue. The Food and Drug Administration (FDA) website shows numerous recalls each year for the past several years, with some that cost the company millions of dollars,” the Tribune article stated.
The Vascu-Guard Patch is s designed for use in peripheral vascular reconstruction and arteriovenous access revisions. On September 1st, The FDA announced that Baxter had recalled certain lots of the product in June, after receiving multiple reports of adverse events in patients undergoing carotid endarterectomy (CEA) surgery. According to the FDA, these incidents involved intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention. Three patient deaths may also be linked to the Vascu-Guard recall.
This most recent action was designated a Class II recall by the FDA, which indicates that the affected products might cause a temporary health problem, or pose a slight threat of a serious nature or death.
The Vascu-Guard Patch was also the subject of a Class I recall in May 2015. Class I is the FDA’s most serious recall category, and indicates that there is a reasonable chance that use of the affected product will result in serious adverse health consequences or death. The first Vascu-Guard Patch recall was issued after Baxter received complaints from customers who experienced difficulty in distinguishing the smooth from rough surface of the patch. This could result in incorrect placement of the patch, increasing the risk that patients will experience vessel thrombosis (blood clot) and/or embolism. In fact, Baxter acknowledged receiving a number of such reports that involved the recalled product codes.