Bard® PTFE Felt 007836Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741041105), received between Nov 23, 2020 and Dec 14, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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.

• MalfunctionDec 14, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO THE GRAFT PLACEMENT PROCEDURE, PACKAGE OF THE DEVICE ALLEGEDLY OPENED AND UNSTERILE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12998730 ↗
• MalfunctionNov 23, 2020Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT PRIOR TO THE VASCULAR GRAFT PROCEDURE, THE DEVICE ALLEGEDLY FOUND TO BE OPENED AND UNSTERILE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10884621 ↗