Distaflo® Bypass Grafts DFX9006SCRecalls & reported problems
Bard Peripheral Vascular, Inc. · Distaflo® Mini-Cuff Bypass Graft With Flex Small Beading, 6 mm x 90 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741023682), received between Mar 17, 2017 and Dec 10, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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
- Material Split, Cut or Torn2
- Torn Material1
Patient problems
- No Consequences Or Impact To Patient2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY TORE ON THE CUFF WHILE SEWING IT UP. REPORTEDLY, THERE WAS PROFUSE BLEEDING FROM THE PUNCTURE CANAL. IT WAS FURTHER REPORTED THAT THE PATIENT WENT TO SURGERY. THE CURRENT PATIENT STATUS WAS UNKNOWN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12974252 ↗MalfunctionJan 2, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PLACEMENT OF GRAFT, THE GRAFT ALLEGEDLY TORE UPON REMOVAL OF THE SPIRAL BEADING. THE TORN MATERIAL OF THE VASCULAR GRAFT WAS REMOVED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8210728 ↗MalfunctionMar 17, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING A BYPASS GRAFT IMPLANTATION FROM THE RIGHT FEMORAL ARTERY TO THE RIGHT ANTERIOR TIBIAL ARTERY, THE BYPASS GRAFT ALLEGEDLY TORE WHILE POSITIONING IT DISTALLY. REPORTEDLY, THE GRAFT WAS REMOVED AND THE HEALTH CARE PROVIDER SWITCHED TO ANOTHER SITE AND SUCCESSFULLY IMPLANTED ANOTHER BYPASS GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6415669 ↗
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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