Bard® Sauvage® Filamentous Knitted Polyester Fabric 007829Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741041051), received between Nov 13, 2018 and Nov 5, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Leak/Splash; Leak/Splash

  A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE ON THE CAROTID ARTERY PROCEDURE USING BARD SAUVAGE FILAMENTOUS FABRIC. DURING THE PROCEDURE, THE PATCH ALLEGEDLY FOUND LEAKING. IT WAS FURTHER REPORTED THAT THE PATCH REMAINED POROUS DESPITE BLOOD SOAKING AND FURTHER USE OF HEMOSTATICS, LEADED TO PERSISTENT BLEEDING AND A LARGE NECK HEMATOMA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23475890 ↗
• MalfunctionNov 9, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE A PROCEDURE, THE OUTER PACKAGE WAS FOUND TORN AND BENT. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757762 ↗
• MalfunctionOct 28, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO SURGICAL GRAFT IMPLANTATION PROCEDURE, PATCH WAS ALLEGEDLY FOUND OPENED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15688929 ↗
• MalfunctionNov 13, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THERE WAS ALLEGEDLY FOREIGN MATERIAL FOUND IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8066911 ↗