Vascu-Guard Patch Stroke
The Vascu-Guard Patch has been named in two product recalls, following reports of issues that could cause patients to experience strokes and other life-threatening adverse health events. Individuals who may have suffered a Vascu-Guard Patch stroke due to these problems could be entitled to compensation from Baxter International, Inc.
Vascu-Guard Injury Claims Now Being Evaluated
Bernstein Liebhard LLP is evaluating Vascu-Guard injury claims involving strokes and other serious complications, such as severe bleeding, hematoma and blood clots. If you or a loved one experienced any of these problems following surgery with a Vascu-Guard Peripheral Vascular Patch, please contact our Firm today at (888) 994-5118.
Vascu-Guard Stroke Warnings
The Vascu-Guard Patch is constructed from bovine heart membrane (pericardium), and is used in peripheral blood vessel repair, including reconstruction of the carotid, renal, iliac, femoral, profunda, and tibial blood vessels. The patch is also indicated for use in arteriovenous access revisions. Since receiving regulatory approval in 2014, Vascu-Guard products have been named in two medical device recalls due to problems that could result in stroke and other adverse health consequences.
2015 Class I Recall
The first – a Class I recall – was announced in May 2015, after Baxter International received complaints from customers that they had difficulty distinguishing the rough and smooth sides of the patch. The company determined that the issue was caused by a recent alteration to packaging. Confusion over the rough and smooth sides could result in the incorrect placement of the Vascu-Guard Patch. If the rough side is allowed to face the blood stream, a blood clot could form on the patch, potentially causing stroke, embolism, reduced blood flow and cardiac arrest. Baxter reported 51 complaints related to this issue and one serious injury.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
2016 Class II Recall
Another recall – Class II—was announced in June 2016 for Vascu-Guard products that had been linked to severe bleeding, both intraoperative and postoperative, in patients undergoing carotid endarterectomy (CEA). The reports included three fatalities involving patches from the recalled product lots. The recall notice warned that severe bleeding from the carotid artery in the neck after CEA can lead to stroke, cardiac arrest, airway obstruction, hypoxia, and diminished brain perfusion. Patients and doctors have been advised to be on the lookout for possible bleeding symptoms, such as neck swelling and difficulty breathing.
Did You Suffer a Stroke 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 strokes. To contact an attorney today, please call (888) 994-5118.
- FDA (2015) “Baxter Healthcare, VASCU-GUARD Peripheral Vascular Patch – May Cause Blood Clots” http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm449825.htm
- FDA (2016) “Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers – Potential Risk of Severe Bleeding and Hematomas” http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518852.htm
- 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
- FDA (2016) “Class 2 Device Recall Synovis VASCUGUARD Peripheral Vascular Patch” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148062
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