Bard® Sauvage® Filamentous Knitted Polyester Fabric 007942Recalls & reported problems
Bard Peripheral Vascular, Inc. · Bard® Sauvage® Filamentous Knitted Polyester Fabric, 2.5 cm x 10.2 cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741041228), received between Jul 7, 2021 and Jul 7, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE DEVICE WAS ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE PATIENT DIAGNOSED WITH HEMATOMA AND BLEEDING. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding
MAUDE report 12126105 ↗
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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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