Class 1 Recall: Baxter Healthcare, VASCU-GUARD Peripheral Vascular Patch - May Cause Blood Clots
Baxter Healthcare, VASCU-GUARD Peripheral Vascular Patch - May Cause Blood Clots
Tue Jun 09 2015
Recall Class: Class I
Date Recall Initiated: May 2, 2015
Device: VASCU-GUARD Peripheral Vascular Patch (also referred to as the VASCU-GUARD patch)
Product Codes Product Description
1504026 VASCU-GUARD TS 1x6cm
1504028 VASCU-GUARD TS 0.8x8cm
1504030 VASCU-GUARD TS 1x10cm
1504032 VASCU-GUARD TS 2x9cm
- Manufacturing dates: January 19,2015 to May 1, 2015
- Distribution dates: March 16, 2015 to May 1, 2015
- Number of Units Distributed in the US: 3,974
- Number of U.S. Customers: 770
- No Out of US Distribution
Use: The VASCU-GUARD patch is used to rebuild peripheral blood vessels such as the carotid in the neck and the renal in the kidneys. It is also used in arteriovenous access revisions.
Recalling Firm:
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, Illinois 60015
Reason for Recall:
Baxter is recalling the VASCU-GUARD patch because it may be difficult for surgeons to distinguish the smooth side from the rough side of the implant. A change in packaging caused the smooth surface of the patch to be too rough. If the rough side of the patch is implanted in the incorrect way, blood clots (thrombus) may form on the patch. This may expose patients to significant health risks, including the movement of blood clots into the blood stream (embolism), reduced blood flow, stroke, organ failure, or death.
Patients who need repair of smaller arteries are at higher risk of blood clots forming within a blood vessel because of slower flow of blood through those vessels. Patients who have blood disorders where excessive blood clots form may also be at a higher risk of forming clots on the surface of the device.
The firm reported 51 complaints related to this issue and one serious injury.