VASCU-GUARD Peripheral Vascular Patch VG0106NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412530871), received between Jul 18, 2023 and Jul 18, 2023 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A LEFT POPLITEAL ARTERIAL SURGERY IN WHICH VASCU-GUARD PATCHES WERE USED. THIS WAS FURTHER SPECIFIED AS ¿A LONGITUDINAL INCISION WAS MADE, AND THE PATCH WAS INSERTED¿ AND ¿THERE WAS NO REINFORCEMENT¿. APPROXIMATELY FIVE YEARS AND THREE MONTHS LATER, AN ANEURYSM WAS DIAGNOSED AND SUBSEQUENTLY RESECTED. IT WAS REPORTED THE ANEURYSM ORIGINATED FROM THE CENTER OF THE DEVICE. ADDITIONAL TREATMENT OR MEDICAL INTERVENTIONS WERE NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm

  MAUDE report 17342274 ↗