Bard® Sauvage® Filamentous Knitted Polyester Fabric 007828Recalls & reported problems

Bard Peripheral Vascular, Inc. · Bard® Sauvage® Filamentous Knitted Polyester Fabric, 10.2 cm x 10.2 cm · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741041044), received between Aug 20, 2024 and Aug 21, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (5 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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Unsealed Device Packaging5

Patient problems

No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 21, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL GRAFT PLACEMENT PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY FOUND TO BE UNSEALED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20014816 ↗
MalfunctionAug 21, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL GRAFT PLACEMENT PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY FOUND TO BE UNSEALED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20014516 ↗
MalfunctionAug 20, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL GRAFT PLACEMENT PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY FOUND TO BE UNSEALED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20006615 ↗
MalfunctionAug 20, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL GRAFT PLACEMENT PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY FOUND TO BE UNSEALED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20005972 ↗
MalfunctionAug 20, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL GRAFT PLACEMENT PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY FOUND TO BE UNSEALED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20004344 ↗

Device details

UDI-DI	`00801741041044`
Brand	Bard® Sauvage® Filamentous Knitted Polyester Fabric
Model	007828
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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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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