Distaflo® Bypass Grafts DF8007SCRecalls & reported problems
Bard Peripheral Vascular, Inc. · Distaflo® Bypass Graft With Flex Small Beading Standard Cuff, 7 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
- 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 00801741023606), received between Nov 23, 2016 and May 7, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Torn Material” (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
- Torn Material2
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient2
- Pseudoaneurysm1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED APPROXIMATELY ONE WEEK POST FEMORAL TIBIAL GRAFT PLACEMENT, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH GROIN PAIN AND WAS DIAGNOSED WITH PSEUDOANEURYSM DUE TO A RUPTURED GRAFT. THE PATIENT UNDERWENT SURGERY TO REPAIR THE AREA. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.
Patient problems: Pseudoaneurysm
MAUDE report 10033057 ↗MalfunctionOct 25, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PLACEMENT OF A VASCULAR GRAFT FOR A BYPASS PROCEDURE, THE GRAFT WAS SUTURED TO THE VESSEL AND ALLEGEDLY TORE UPON REMOVAL OF THE SPIRAL BEADING. THE VASCULAR GRAFT WAS REMOVED AND A NEW GRAFT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6978372 ↗MalfunctionNov 23, 2016Torn Material; Torn Material
IT WAS REPORTED THAT DURING REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE DURING TREATMENT IN A CALCIFIED LEG. REPORTEDLY, THE SURGICAL GRAFT WAS CUT AND THE REMAINDER OF THE GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6125293 ↗
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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