Bard® PTFE Felt 007975Recalls & reported problems

Bard Peripheral Vascular, Inc. · Bard® PTFE Felt, 1.3 cm x 10.2 cm · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Bard PTFE Felt is a soft surgical patch used to reinforce or repair tissue and blood vessels during operations. The 28 reports filed against it describe packaging and paperwork problems, mainly that the patient information card was not included in the package, rather than problems with the felt itself, and none mention a death or an injury. Most reports arrived recently, with 24 in the past 12 months compared with 4 in the year before. No recalls name 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: 28
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741041396), received between Oct 31, 2025 and Nov 28, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (28 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Incomplete or Missing Packaging28
Missing Information4

Patient problems

No Clinical Signs, Symptoms or Conditions28

Recent adverse event reports

The 25 most recent of 28 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 PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23670162 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23670098 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23670092 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669536 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669219 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669217 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669212 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669209 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669208 ↗
MalfunctionNov 27, 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 WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669123 ↗
MalfunctionNov 27, 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 WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23665082 ↗
MalfunctionNov 27, 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 WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23664430 ↗
MalfunctionNov 27, 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 WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23664427 ↗
MalfunctionNov 27, 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 WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23664425 ↗
MalfunctionNov 27, 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 WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23664424 ↗
MalfunctionNov 27, 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 WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23664183 ↗
MalfunctionNov 27, 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 WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23664091 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE OF PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23663668 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE OF PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23663595 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE OF PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23663592 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE OF PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23663563 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE OF PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23663562 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE OF PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23663560 ↗
MalfunctionNov 27, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE OF PTFE FELT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT INFORMATION CARD WAS NOT RECEIVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23663538 ↗
MalfunctionOct 31, 2025Incomplete or Missing Packaging; Missing Information; Incomplete or Missing Packaging; Missing Information
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE OF PTFE FELT DEVICE. DURING THE PROCEDURE A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23434134 ↗

Device details

UDI-DI	`00801741041396`
Brand	Bard® PTFE Felt
Model	007975
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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Bard® PTFE Felt Pledgets 007963
Bard Peripheral Vascular, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
37 reports

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

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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