Distaflo® Bypass Grafts DFM8006SCRecalls & reported problems
Bard Peripheral Vascular, Inc. · Distaflo® Bypass Graft With Flex Small Beading Small Cuff, 6mm 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741000164), received between Mar 16, 2016 and May 6, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Torn Material” (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.
Reports received per month
Most reported problems
Device problems
- Torn Material4
- Material Split, Cut or Torn2
- Peeled/Delaminated1
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, WHEN INSERTING THE PRODUCT, THE EXTERNAL SPIRAL SUPPORT BEADINGS ALLEGEDLY CAME APART. IT WAS FURTHER REPORTED THAT THE BEADINGS ALLEGEDLY POPPED OFF THE GRAFT AND THE GRAFT HAD FLATTENED. REPORTEDLY, THE GRAFT WAS REMOVED WITH BEADINGS STILL ON IT AND THE PROCEDURE WAS COMPLETED BY INSERTING ANOTHER GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19246635 ↗MalfunctionOct 28, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DFM8006SC BYPASS GRAFT ALLEGEDLY EXPERIENCED MATERIAL SPLIT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE WEIGHT OF (B)(6) YEAR OLD MALE PATIENT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10750348 ↗MalfunctionApr 13, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DFM8006SC EPTFE VASCULAR GRAFT ALLEGEDLY EXPERIENCED MATERIAL SPLIT, CUT OR TORN. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9954586 ↗MalfunctionMar 30, 2018Torn Material; Torn Material
IT WAS REPORTED THAT WHILE SUTURING THE FEMORAL (PROXIMAL) ANASTOMOSIS SITE OF THE EPTFE GRAFT, THE GRAFT ALLEGEDLY TORE. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER MADE REVISIONS TO THE GRAFT AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7386363 ↗MalfunctionFeb 7, 2018Torn Material; Torn Material
IT WAS REPORTED THAT THE VASCULAR GRAFT ALLEGEDLY TORE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7247898 ↗MalfunctionNov 6, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PLACEMENT OF AN EPTFE VASCULAR GRAFT, UPON MANIPULATION OF THE GRAFT WHILE SUTURING, THE GRAFT ALLEGEDLY TORE. IT WAS FURTHER REPORTED THAT THE TORN MATERIAL OF THE VASCULAR GRAFT WAS REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7003615 ↗MalfunctionMar 16, 2016Torn Material; Torn Material
IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, WHILE THE BEADING WAS REMOVED FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 5504752 ↗
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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