Bard® PTFE Felt 007976Recalls & reported problems

Bard Peripheral Vascular, Inc. · Bard® PTFE Felt, 2.5 cm x 15.2 cm · Class 2 · Implant

Adverse event reports: 14
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741041402), received between Apr 15, 2020 and Nov 29, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (13 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Incomplete or Missing Packaging13
Missing Information3
Material Erosion1
Material Frayed1

Patient problems

No Clinical Signs, Symptoms or Conditions13
No Consequences Or Impact To Patient1

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 29, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675642 ↗
MalfunctionNov 29, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675641 ↗
MalfunctionNov 29, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE IS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675640 ↗
MalfunctionNov 29, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675639 ↗
MalfunctionNov 29, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675638 ↗
MalfunctionNov 29, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675633 ↗
MalfunctionNov 29, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675628 ↗
MalfunctionNov 29, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. IT WAS REPORTED THAT DURING TO A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675627 ↗
MalfunctionNov 29, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675626 ↗
MalfunctionNov 19, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD. THERE IS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23591697 ↗
MalfunctionNov 3, 2025Incomplete or Missing Packaging; Missing Information; Incomplete or Missing Packaging; Missing Information
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD. THERE IS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23446947 ↗
MalfunctionNov 3, 2025Incomplete or Missing Packaging; Missing Information; Incomplete or Missing Packaging; Missing Information
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD. THERE IS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23446928 ↗
MalfunctionNov 3, 2025Incomplete or Missing Packaging; Missing Information; Incomplete or Missing Packaging; Missing Information
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD. THERE IS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23446926 ↗
MalfunctionApr 15, 2020Material Erosion; Material Frayed; Material Erosion; Material Frayed
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 007976 PTFE FELT ALLEGEDLY EXPERIENCED MATERIAL EROSION AND FRAYED MATERIAL. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9965645 ↗

Device details

UDI-DI	`00801741041402`
Brand	Bard® PTFE Felt
Model	007976
Company	Bard Peripheral Vascular, Inc.
Product code	DXZ · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 5, 2021

Device type (GMDN): Cardiovascular patch, synthetic

An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).

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