Venaflo® II ePTFE Vascular Grafts VLT4046CRecalls & reported problems
Bard Peripheral Vascular, Inc. · Venaflo® II ePTFE Vascular Graft WITH CARBON STEPPED, 4-6 mm x 40 cm · Class 2 · Implant
All models of Venaflo II ePTFE Vascular Grafts (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741020582), received between Mar 23, 2020 and Aug 26, 2020 — classified as 5 injuries.
The most frequently reported specific device problem is “Leak/Splash” (4 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.
Most reported problems
Device problems
- Leak/Splash4
- Obstruction of Flow1
Patient problems
- Unspecified Infection4
- Swelling1
- Thrombus1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2020Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED ONE DAY POST VASCULAR GRAFT PLACEMENT, THERE WAS NO MURMUR OR TREMOR. ULTRASOUND DEMONSTRATED THROMBI WITHIN THE GRAFT AND THE GRAFT WAS REMOVED AND REVEALED A COLLAPSED LUMEN. A NEW GRAFT WAS PLACED AND BLOOD FLOW WAS RESTORED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.
Patient problems: Swelling; Thrombus
MAUDE report 10453738 ↗InjuryMar 23, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT POST-SURGICAL GRAFT IMPLANTATION IN AVF, THE SURGICAL GRAFT LEAKED FLUID AND THE PATIENT EXPERIENCED INFECTION WITHIN THE HOSPITAL. IT WAS FURTHER REPORTED THAT THE INFECTION WAS TREATED FOR TWO WEEKS WITH ANTIBIOTICS AND THAT THE SURGICAL GRAFT WILL REMAIN IMPLANTED. THE HEALTHCARE PROVIDER (HCP) WILL CONTINUE TO OBSERVE THE PATIENT'S SYMPTOMS. THE PATIENT IS REPORTEDLY STABLE.
Patient problems: Unspecified Infection
MAUDE report 9869368 ↗InjuryMar 23, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT POST-SURGICAL GRAFT IMPLANTATION IN AVF, THE SURGICAL GRAFT LEAKED FLUID AND THE PATIENT EXPERIENCED INFECTION WITHIN THE HOSPITAL. IT WAS FURTHER REPORTED THAT THE INFECTION WAS TREATED FOR TWO WEEKS WITH ANTIBIOTICS AND THAT THE SURGICAL GRAFT WILL REMAIN IMPLANTED. THE HEALTHCARE PROVIDER (HCP) WILL CONTINUE TO OBSERVE THE PATIENT'S SYMPTOMS. THE PATIENT IS REPORTEDLY STABLE.
Patient problems: Unspecified Infection
MAUDE report 9869204 ↗InjuryMar 23, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT POST-SURGICAL GRAFT IMPLANTATION IN AVF, THE SURGICAL GRAFT LEAKED FLUID AND THE PATIENT EXPERIENCED INFECTION WITHIN THE HOSPITAL. IT WAS FURTHER REPORTED THAT THE INFECTION WAS TREATED FOR TWO WEEKS WITH ANTIBIOTICS AND THAT THE SURGICAL GRAFT WILL REMAIN IMPLANTED. THE PATIENT IS REPORTED AS STABLE.
Patient problems: Unspecified Infection
MAUDE report 9869181 ↗InjuryMar 23, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT POST-SURGICAL GRAFT IMPLANTATION IN AVF, THE SURGICAL GRAFT LEAKED FLUID AND THE PATIENT EXPERIENCED INFECTION WITHIN THE HOSPITAL. IT WAS FURTHER REPORTED THAT THE INFECTION WAS TREATED FOR TWO WEEKS WITH ANTIBIOTICS AND THAT THE SURGICAL GRAFT WILL REMAIN IMPLANTED. THE HEALTHCARE PROVIDER (HCP) WILL CONTINUE TO OBSERVE THE PATIENT'S SYMPTOMS. THE PATIENT IS REPORTEDLY STABLE.
Patient problems: Unspecified Infection
MAUDE report 9868458 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
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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