Bard® PTFE Felt 007973Recalls & reported problems

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

Adverse event reports: 22
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741041372), received between Oct 29, 2025 and Nov 28, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (22 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 Packaging22
Missing Information2

Patient problems

No Clinical Signs, Symptoms or Conditions22

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669674 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669537 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669535 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669529 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655489 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655258 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655256 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655009 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655008 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654918 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654915 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654913 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654513 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654511 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654510 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654507 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654489 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654487 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654210 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD (PIC) WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654205 ↗
MalfunctionOct 29, 2025Incomplete or Missing Packaging; Missing Information; Incomplete or Missing Packaging; Missing Information
IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23412162 ↗
MalfunctionOct 29, 2025Incomplete or Missing Packaging; Missing Information; Incomplete or Missing Packaging; Missing Information
IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE USING THE PTFE FELT DEVICE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23412129 ↗

Device details

UDI-DI	`00801741041372`
Brand	Bard® PTFE Felt
Model	007973
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.