GORE-TEX Cardiovascular Patch 1802009004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132600694), received between Jun 5, 2024 and Jun 5, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Lack of Effect” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2024Lack of Effect; Lack of Effect

  IT WAS REPORTED THE PHYSICIAN SELECTED A GORE-TEX® CARDIOVASCULAR PATCH FOR CAROTID ARTERY REPAIR. THE PHYSICIAN STATED TWO UNITS OF BLOOD WAS LOST DURING THE PROCEDURE AS A RESULT OF BLEEDING FROM THE SUTURE HOLES IN THE PATCH. THERE WERE NO REPORTS OF SUTURE PULL-OUT OR PATCH TEARING. THE PATIENT WAS GIVEN TWO UNITS OF BLOOD DURING THE PROCEDURE, AND WAS DOING WELL AFTERWARDS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19471224 ↗
• InjuryJun 5, 2024Lack of Effect; Lack of Effect

  IT WAS REPORTED THE PHYSICIAN SELECTED A GORE-TEX® CARDIOVASCULAR PATCH FOR CAROTID ARTERY REPAIR. THE PHYSICIAN STATED TWO UNITS OF BLOOD WAS LOST DURING THE PROCEDURE AS A RESULT OF BLEEDING FROM THE SUTURE HOLES IN THE PATCH. THERE WERE NO REPORTS OF SUTURE PULL-OUT OR PATCH TEARING. THE PATIENT WAS GIVEN TWO UNITS OF BLOOD DURING THE PROCEDURE, AND WAS DOING WELL AFTERWARDS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19471007 ↗