Vascu-Guard Patch Blood Clots

The Vascu-Guard Patch has been named in two product recalls, following report that patients had experienced blood clots and other serious complications following surgery with the device. Individuals who suffered Vascu-Guard patch blood clots may be entitled to compensation from Baxter International, Inc.

Potential Vascu-Guard Lawsuits Now Being Evaluated

Bernstein Liebhard LLP is evaluating Vascu-Guard lawsuits involving blood clots and other serious complications, such as severe bleeding, hematoma and stroke. If you or a loved one experienced any of these problems following peripheral blood vessel repair, carotid endarterectomy (CEA), or arteriovenous access revisions that involved  a Vascu-Guard Peripheral Vascular Patch, please contact our Firm today at (888) 994-5118.

Vascu-Guard Blood Clot Warnings

The Vascu-Guard Patch is used to repair peripheral blood vessels, including carotid, renal, iliac, femoral, profunda, and tibial blood vessels. The device, which is made from bovine pericardium sourced from U.S cattle, is also used in arteriovenous access revisions.

2015 Vascu-Guard Recall for Blood Clots

While the Vascu-Guard Patch was only cleared for sale in November 2014, it has already been the subject of two safety warnings for blood clots, severe bleeding and other life-threatening complications. In May 2015, a Class I recall – the U.S. Food & Drug Administration’s (FDA) most serious type of recall –was announced for certain Vascu-Guard products that had been linked to blood clots. According to the FDA, Baxter International had issued the recall after it was determined that a packaging alteration had caused the smooth surface of the patch to be too rough. Confusion between the smooth and rough sides of the device could result in incorrect implantation of the Vascu-Guard Patch, allowing blood clots to form on the patch.

According to the FDA, Baxter International had reported 51 complaints, including some involving postoperative thrombosis and stroke, related to the Vascu-Guard Patch recall. If a blood clot does form on a patch, affected patients may experience life-threatening complications, including embolism, reduced blood flow, stroke, organ failure, or death.

2016 Vascu-Guard Recall for Severe Bleeding

In June 2016, Baxter International announced a voluntary recall for Vascu-Guard Patch products that had been linked to severe bleeding in patients undergoing carotid endarterectomy (CEA). Reports from 2016 included intraoperative and postoperative bleeding and hematomas, as well as three patient deaths.

According to the FDA, severe bleeding from the carotid artery in the neck after CEA can lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest. Patients and doctors have been advised to be on the lookout for possible bleeding symptoms, neck swelling and difficulty breathing.

Blood Clot Symptoms

Blood clots occur when platelets and fibrin in the blood clump together. It’s normal for a blood clot to develop when the body needs to repair a blood vessel, such as an artery or vein. However, they can also form inappropriately in patients who suffer from certain heart conditions or other health problems.

Generalized blood clot symptoms include:

  • Swelling of the affected area
  • Warmth in the affected area
  • Redness in the affected area
  • Pain in the affected area

Blood clots may cause other specific symptoms depending on their location:

  • Deep vein thrombosis (DVT, or a clot in the legs) will present with pain, redness and swelling).
  • A pulmonary embolism (a clot that has traveled to the lungs) will cause chest pain, shortness of breath, and rapid pulse and breathing.
  • Patients who suffer a stroke (due to a blood clot in the brain) may experience loss of speech, vision, and weakness on one side of the body.
  • A blood clot in the coronary artery will cause a heart attack, symptoms of which include chest pain, shortness of breath, nausea, indigestion, and sweating.
  • A blood clot in an artery that supplies the intestine (mesenteric ischemia) will cause abdominal pain, nausea and blood in the stool.

Did You Suffer a Blood Clot Following Vascu-Guard Patch Surgery? Contact an Attorney Today.

Bernstein Liebhard LLP provides free, no-obligation legal reviews to the alleged victims of Vascu-Guard Patch blood clots. To contact an attorney today, please call (888) 994-5118.

  1. FDA (2016) “Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers – Potential Risk of Severe Bleeding and Hematomas”
  2. FDA (2016) “Potential Risk of Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers”
  3. FDA (2016) “Class 2 Device Recall Synovis VASCUGUARD Peripheral Vascular Patch”
  4. FDA (2015) “Baxter Healthcare, VASCU-GUARD Peripheral Vascular Patch – May Cause Blood Clots”
Last Modified: September 9, 2016

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