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Bard® PTFE Felt Pledgets 007970Recalls & reported problems

Bard Peripheral Vascular, Inc. · Bard® PTFE Felt Pledgets, (Rectangle), 4.8 mm x 6 mm · Class 2 · Implant

Quick summary

This Bard PTFE felt pledget is a small rectangular patch used to reinforce surgical sites. All 33 reports describe the same thing: staff opening the package and finding bits of foreign material or contamination on the device, then completing the procedure with another pledget without patient contact. No deaths and no injuries were reported, and there are no recalls naming this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
33
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741041341), received between May 5, 2021 and Jun 7, 2023 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (33 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

Device problems

  • Device Contamination with Chemical or Other Material33

Patient problems

  • No Clinical Signs, Symptoms or Conditions33

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, A MICRO FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17081031 ↗
  • MalfunctionMay 10, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, A CONTAMINATION OF FOREIGN MATERIAL WAS ALLEGEDLY FOUND. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16901288 ↗
  • MalfunctionMay 10, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED ON THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16901235 ↗
  • MalfunctionMay 10, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, A CONTAMINATION OF FOREIGN MATERIAL WAS ALLEGEDLY FOUND. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16900564 ↗
  • MalfunctionMay 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, A MICRO FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16858340 ↗
  • MalfunctionApr 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, UPON OPENING THE PACKAGE, CONTAMINATION OF FOREIGN MATERIAL WAS ALLEGEDLY FOUND. 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 16790580 ↗
  • MalfunctionApr 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, UPON OPENING THE PACKAGE, CONTAMINATION OF FOREIGN MATERIAL WAS ALLEGEDLY FOUND. 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 16790571 ↗
  • MalfunctionApr 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING PREPARATION, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16775440 ↗
  • MalfunctionApr 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE CONTAMINATION OF FOREIGN MATERIAL WAS ALLEGEDLY FOUND. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16671801 ↗
  • MalfunctionMar 24, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16610093 ↗
  • MalfunctionMar 15, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING PREPARATION, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16546692 ↗
  • MalfunctionMar 15, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING PREPARATION, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THERE WAS NO REPORTED PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16545631 ↗
  • MalfunctionMar 2, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING PREPARATION, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THERE WAS NO REPORTED PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16465903 ↗
  • MalfunctionFeb 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT UPON OPENING THE DEVICE, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED ON THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16292431 ↗
  • MalfunctionNov 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15884538 ↗
  • MalfunctionNov 26, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE PACKAGE UPON OPENING THE DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15866795 ↗
  • MalfunctionNov 25, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE PACKAGE UPON OPENING THE DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15864853 ↗
  • MalfunctionNov 21, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT UPON OPENING THE DEVICE, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED ON THE DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15832265 ↗
  • MalfunctionNov 21, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT UPON OPENING THE DEVICE, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED ON THE DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15832170 ↗
  • MalfunctionOct 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15690173 ↗
  • MalfunctionNov 19, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL GRAFT PLACEMENT PROCEDURE, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12846569 ↗
  • MalfunctionMay 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT DURING THE PREPARATION FOR A PROCEDURE, A FOREIGN MATERIAL WAS ALLEGEDLY FOUND INSIDE THE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11853863 ↗
  • MalfunctionMay 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, A FOREIGN MATERIAL WAS ALLEGEDLY FOUND INSIDE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11853832 ↗
  • MalfunctionMay 20, 2021Device 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 IN THE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11853809 ↗
  • MalfunctionMay 18, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11840342 ↗

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

All PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE devices →

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