Venaflo II ePTFE Vascular GraftsRecalls & reported problems across all models

We found 9 models of Venaflo II ePTFE Vascular Grafts by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2016 and Apr 18, 2026 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Venaflo II ePTFE Vascular Grafts problems

Venaflo II ePTFE Vascular Grafts models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Venaflo® II ePTFE Vascular Grafts VLT4046C

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  5 reports
• Venaflo® II ePTFE Vascular Grafts VLT4047C

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  5 reports
• Venaflo® II ePTFE Vascular Grafts VL4006C

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  4 reports
• Venaflo® II ePTFE Vascular Grafts VL5006C

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• Venaflo® II ePTFE Vascular Grafts VL4007C

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• Venaflo® II ePTFE Vascular Grafts VLT2046C

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• Venaflo® II ePTFE Vascular Grafts VLT2546C

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• Venaflo® II ePTFE Vascular Grafts VLT2547C

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• Venaflo® II ePTFE Vascular Grafts VLT4547C

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report

Recent Venaflo II ePTFE Vascular Grafts adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A HEMODIALYSIS ACCESS PROCEDURE USING THE VENAFLO. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT A HAIR IS ENCLOSED WITHIN THE OUTER PACKAGING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919146 ↗
• MalfunctionApr 18, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A HEMODIALYSIS ACCESS PROCEDURE USING THE VENAFLO. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT A HAIR IS ENCLOSED WITHIN THE OUTER PACKAGING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919145 ↗
• MalfunctionApr 18, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A HEMODIALYSIS ACCESS PROCEDURE USING THE VENAFLO. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT A HAIR IS ENCLOSED WITHIN THE OUTER PACKAGING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919143 ↗
• MalfunctionApr 18, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A HEMODIALYSIS ACCESS PROCEDURE USING THE VENAFLO. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT A HAIR IS ENCLOSED WITHIN THE OUTER PACKAGING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919142 ↗
• MalfunctionApr 18, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A HEMODIALYSIS ACCESS PROCEDURE USING THE VENAFLO. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT A HAIR IS ENCLOSED WITHIN THE OUTER PACKAGING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919141 ↗
• InjuryNov 19, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT SURGICAL GRAFT PLACEMENT PROCEDURE USING A VENAFLO PROSTHESIS VIA HUMERAL AXILLARY ARTERIOVENOUS. POST IMPLANTATION, A STERILE FLUID COLLECTION DEVELOPED AND WAS EVACUATED ON (B)(6) 2025. THE COLLECTION REFORMED AND REPEATED SURGERY REVEALED OOZING FROM A FRIABLE SEGMENT OF THE PROSTHESIS. THE SEGMENT WAS REPLACED AND TESTED, CONFIRMING STAPHYLOCOCCUS EPIDERMIDIS CONTAMINATION ON (B)(6) 2025. THE CURRENT STATUS OF THE PATIENT IS STABLE NOW.

  Patient problems: Bacterial Infection

  MAUDE report 23590798 ↗
• MalfunctionAug 26, 2025Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE EXPIRY DATE ON THE PRODUCT WAS ALLEGEDLY INCORRECT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892420 ↗
• MalfunctionJun 16, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO THE GRAFT PLACEMENT PROCEDURE, PACKAGE OF THE DEVICE ALLEGEDLY HAD A SLIT OR CUT AROUND THE ACTUAL GRAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008088 ↗
• MalfunctionOct 22, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL VL5006C VASCULAR GRAFT ALLEGEDLY EXPERIENCED DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. PATIENTS' AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10722926 ↗
• MalfunctionOct 22, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL VL5006C VASCULAR GRAFT ALLEGEDLY EXPERIENCED MATERIAL SPLIT, CUT OR TORN. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD MALE PATIENT IS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722925 ↗
• 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 ↗
• InjuryAug 17, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT POST DIALYSIS GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD TEARS AT THE PUNCTURE SITE. IT WAS FURTHER REPORTED THAT HEMORRHAGE WAS OBSERVED. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10413540 ↗
• 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 ↗

Other Bard Peripheral Vascular, Inc. products

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