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Vascu-Guard VG0108Recalls & reported problems

Synovis Life Technologies, Inc. · VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412818498), received between Apr 10, 2023 and Apr 10, 2023 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K221032); they may or may not involve this specific model.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PATIENT UNDERWENT A CAROTID ENDARTERECTOMY PROCEDURE IN WHICH VASCU-GUARD PATCHES WERE USED. IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED A SURGICAL SITE INFECTION. THE CAUSE OF THE INFECTION WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: Unspecified Infection

    MAUDE report 16709424 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221032. One submission often covers many models, so check the product and lot details in each record.

  • Z-0666-2024 · Dec 6, 2023 · Open, Classified
    Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TS

Other Intracardiac Patch Or Pledget, Biologically Derived devices

All Intracardiac Patch Or Pledget, Biologically Derived devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.