Distaflo® Bypass Grafts DFX7006SCRecalls & reported problems
Bard Peripheral Vascular, Inc. · Distaflo® Mini-Cuff Bypass Graft With Flex Small Beading, 6 mm x 70 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 00801741023668), received between Mar 16, 2018 and Nov 25, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 Split, Cut or Torn1
- Obstruction of Flow1
- Torn Material1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED DURING SURGICAL GRAFT PLACEMENT PROCEDURE, THE GRAFT ALLEGEDLY TORNED. IT WAS FURTHER REPORTED THAT GRAFT ALLEGEDLY TORE IN SEVERAL PLACES WAS THEN SEWN BACK ON THE TORN AREAS DURING THE SURGERY. REPORTEDLY, THE GRAFT WAS LEFT IN THE PATIENT AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10902406 ↗InjuryDec 3, 2018Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST BYPASS GRAFT IMPLANTATION IN THE SFA TO THE POPLITEAL ARTERY, THE VASCULAR GRAFT WAS ALLEGEDLY THROMBOSED WITH NO BLOOD FLOW TO THE FOOT. THE PATIENT UNDERWENT SURGERY TO IMPLANT A SECOND BYPASS GRAFT.
Patient problems: No Consequences Or Impact To Patient; Thrombosis
MAUDE report 8124287 ↗MalfunctionMar 16, 2018Torn Material; Torn Material
IT WAS REPORTED THAT DURING INTRAOPERATIVE BEADING REMOVAL, HOLES IN THE GRAFT WERE ALLEGEDLY IDENTIFIED AT THE SITE OF THE REMOVED BEADING. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER REVISED THE GRAFT AND REMOVED THE AFFECTED SEGMENT. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7347155 ↗
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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