Bard® PTFE Felt Pledgets 007963Recalls & reported problems

Bard Peripheral Vascular, Inc. · Bard® PTFE Felt Pledgets, (Rectangle), 9.5 mm x 4.8 mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

These are small rectangular felt pledgets Bard makes to reinforce surgical sites where tissue is stitched. The 37 reports mostly describe packaging arriving incomplete or without the patient information card, and none mention patient injuries or deaths. Reports jumped from 4 in the prior12 months to 33 in the most recent one, and 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: 37
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741041303), received between Oct 23, 2025 and Nov 28, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (37 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 Packaging37
Missing Information4

Patient problems

No Clinical Signs, Symptoms or Conditions37

Recent adverse event reports

The 25 most recent of 37 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 PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669435 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669434 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669433 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669432 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669380 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669378 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669377 ↗
MalfunctionNov 28, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669375 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654211 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654206 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654149 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654087 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654047 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654046 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654033 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654032 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654031 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653873 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653870 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653628 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653627 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653543 ↗
MalfunctionNov 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653542 ↗
MalfunctionNov 25, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23642476 ↗
MalfunctionNov 25, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging
A PATIENT UNDERWENT A SURGICAL PLACEMENT PROCEDURE USING PLEDGETS. IT WAS REPORTED THAT DURING A SURGICAL PLACEMENT PROCEDURE, A CUSTOMER REPORTED NOT RECEIVING THE PATIENT INFORMATION CARD (PIC). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23642475 ↗

Device details

UDI-DI	`00801741041303`
Brand	Bard® PTFE Felt Pledgets
Model	007963
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 007970
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33 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page