FDA Releases Update on Baxter International's Vascu-Guard Patch Recall
The FDA today released an update on Baxter‘s (NYSE:BAX) voluntary recall of its Vascu-Guard peripheral vascular patch, saying that it is working with the company but that neither group has discovered a root cause for the issues, which led to a number of adverse events and 3 potential patient deaths.
The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said.
While the federal watchdog said it has yet to discover the cause of the issue, it did offer that so far, there have been no new events related to the issues during carotid endarterectomy surgeries since the recall was initiated last September.
The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said.
While the federal watchdog said it has yet to discover the cause of the issue, it did offer that so far, there have been no new events related to the issues during carotid endarterectomy surgeries since the recall was initiated last September.