Baxter Healthcare has issued a Class I Recall for the VASCU-GUARD Peripheral Vascular Patch after users complained about not being able to tell which side of the patch to apply, resulting in adverse health complications including blood clots and stroke.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered a blood clot or other injury after using a Baxter Peripheral Vascular Patch, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: Deaths Prompt FDA Warning on Baxter Vascu-Guard Patch
September 1, 2016 – FDA has received adverse event reports of bleeding, hematomas and death associated with the Baxter Vascu-Guard Peripheral Vascular Patch (“Vascu-Guard patch”) when used during carotid endarterectomy (CEA). The agency is concerned that the devices may not be performing as intended and that patients may be at risk for adverse health consequences.
VASCU-GUARD Vascular Patch May Cause Blood Clots: FDA Warning
June 1, 2015 – The Vascu-Guard Patch recall was announced today by the U.S. Food & Drug Administration (FDA), impacting the following product codes linked to reports of stroke and post-operative blood clots (thrombosis):
- 1504026 VASCU-GUARD TS 1x6cm
- 1504028 VASCU-GUARD TS 0.8x8cm
- 1504030 VASCU-GUARD TS 1x10cm
- 1504032 VASCU-GUARD TS 2x9cm
The patches are used in peripheral vascular reconstruction and arteriovenous access revisions.
According to the FDA, Baxter received complaints from users who had problems telling the smooth side of the patch from the rough side, leading to incorrect placement and the rough side being applied toward the blood stream. This error can increase the risk of vessel thrombosis and embolism, according to Baxter.
Baxter says the problem is caused by a deviation in the surface texture of the vascular patch in new packaging configurations. The company says it is investigating the issue, but warns of the risk of thrombosis linked to vascular procedures in patients with underlying vascular conditions.
Baxter says it began notifying its U.S. customers on May 2, directing them to remove all affected products from their inventory.
Do I Have a Baxter Peripheral Vascular Patch Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Baxter Peripheral Patch Lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one suffered a blood clot or other injury after using a Baxter Peripheral Vascular Patch, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.