Distaflo® Bypass Grafts DF8006SCRecalls & reported problems
Bard Peripheral Vascular, Inc. · Distaflo® Bypass Graft With Flex Small Beading Standard Cuff, 6 mm x 80 cm · Class 2 · Implant
All models of Distaflo Bypass Grafts (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741023590), received between Mar 31, 2017 and Aug 2, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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
- Material Puncture/Hole1
- Torn Material1
Patient problems
- No Patient Involvement1
- Pseudoaneurysm1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THREE MONTHS POST A SURGICAL GRAFT PLACEMENT PROCEDURE, GRAFT MATERIAL ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PSEUDOANEURYSM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Pseudoaneurysm
MAUDE report 17442837 ↗MalfunctionMar 31, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING A PROCEDURE TO REPAIR THE FEMORAL ARTERY, UPON OPENING THE PACKAGE, THE VASCULAR GRAFT WAS ALLEGEDLY SPLIT, RENDERING THE GRAFT UNUSABLE. ANOTHER VASCULAR GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6450643 ↗
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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