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Bard® PTFE Felt (Thick) 007959Recalls & reported problems

Bard Peripheral Vascular, Inc. · Bard® PTFE Felt (Thick), 15.2 cm x 15.2 cm · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741041297), received between Apr 19, 2019 and Jul 8, 2022 — classified as 2 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

Device problems

  • Device Contamination with Chemical or Other Material1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE FOREIGN MATERIAL WAS ALLEGEDLY FOUND ON THE DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14952789 ↗
  • MalfunctionApr 19, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

    THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 7959 BARD PTFE FELT EXPERIENCED A MATERIAL SPLIT, CUT OR TORN. OF THIS EVENT, THE DEVICE WAS USED ON THE PATIENT WITH NO REPORTED INJURY. THE PATIENT WAS A (B)(6) YEAR-OLD MALE WITH WEIGHT NOT PROVIDED. THE 7959 BARD PTFE FELT WAS NOT RETURNED TO THE MANUFACTURER LIMITING INVESTIGATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8533458 ↗

Other PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE devices

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Sources and updates

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