Vascu-Guard Patch Severe Bleeding

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.

Attorneys Investigating Vascu-Guard Patch and Reports of Internal Bleeding

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.

Vascu-Guard Patch: What’s the Problem?

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:

  • Airway obstruction
  • Hypoxia
  • Diminished brain perfusion
  • Stroke
  • Cardiac arrest

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:

  • 1 cm x 6 cm, Product Code VG0106N
  • 8 cm x 8 cm, Product Code VG0108N
  • 1 cm x 10 cm, Product Code VG0110N
  • 2 cm x 9 cm, Product Code VG0209N

A complete list of affected lots can be accessed at the FDA’s website.

Did You Experience Severe Bleeding from Vascu-Guard? Contact an Attorney Today.

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.

  1. FDA (2016) “Potential Risk of Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers” http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm518804.htm
  2. FDA (2016) “Class 2 Device Recall Synovis VASCUGUARD Peripheral Vascular Patch” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148062
Last Modified: September 9, 2016

Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.

 
 
 

Follow Us

RXInjuryHelp.com on Google+  RXInjuryHelp.com on Facebook  RXInjuryHelp.com on LinkedIn  RXInjuryHelp.com on Twitter  RXInjuryHelp.com on YouTube  RXInjuryHelp.com on Pinterest