Vascu-Guard Patch Recall News: Rival Device Maker Benefits From Baxter’s Woes

Published on October 27, 2016 by Sandy Liebhard

Medical device maker LeMaitre Vascular, Inc. appears to have benefited from Baxter International, Inc.’s recent Vascu-Guard Patch recall. According to the company’s most recent earnings report, its own XenoSure patch racked up incremental sales of about $1.4mm during the third quarter of 2016, thanks to the Baxter recall. LeMaitre expects to retain approximately $500,000 of the increased patch sales in the year’s final quarter.

Like devices included in Baxter’s Vascu-Guard Patch line, LeMaitre’s XenoSure products are manufactured from bovine pericardium. They are indicated for use in precision endarterectomy and vascular reconstruction.

Vascu-Guard Recall

Baxter International announced a recall for certain lots of the Vascu-Guard Peripheral Vascular Patch in June, after receiving multiple reports of adverse events in patients undergoing carotid endarterectomy (CEA) surgery. The action was  designated a Class II recall by the U.S. Food & Drug Administration (FDA), which indicates that the affected products might cause a temporary health problem, or pose a slight threat of a serious nature or death.

Risks associated with the recalled devices include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention. The FDA noted that three patient deaths may also be linked to the affected Vascu-Guard Patches.

Baxter began releasing newly manufactured lots in August 2016 to fulfill Vascu-Guard orders.

The June recall marked the second time Baxter was forced to pull some of its Vascu-Guard products from the market. In May 2015, the company issued a Class I recall for another group of patches, following complaints from customers who had experienced difficulty in distinguishing the smooth from rough surface as described in the instructions for use. If the rough side of the Vascu-Guard Patch is implanted incorrectly, blood clots may form on the patch, potentially leading to embolism, reduced blood flow, stroke, organ failure, or death.

A Class I recall is the FDA’s most serious type of recall, and indicates that a medical product poses a significant risk of serious injury or death.