Distaflo® Bypass Grafts DFX8006SCRecalls & reported problems
Bard Peripheral Vascular, Inc. · Distaflo® Mini-Cuff Bypass Graft With Flex Small Beading, 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741023675), received between Sep 19, 2016 and Oct 15, 2019 — classified as 6 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.
Most reported problems
Device problems
- Torn Material4
- Material Split, Cut or Torn2
Patient problems
- No Consequences Or Impact To Patient5
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DFX8006SC DISTAFLO BYPASS GRAFT ALLEGEDLY EXPERIENCED MATERIAL SPLIT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS A (B)(6) MALE WEIGHING (B)(6) KGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9193018 ↗MalfunctionOct 16, 2018Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PLACEMENT OF THE VASCULAR 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 7970823 ↗MalfunctionJun 21, 2018Torn 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 IN THE PTFE UPON REMOVAL OF THE SPIRAL BEADING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7627361 ↗MalfunctionSep 8, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PREPARATION, A VASCULAR GRAFT WAS ALLEGEDLY CRACKED AT THE GRAFT CUFF. A NEW VASCULAR GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6853789 ↗MalfunctionDec 19, 2016Torn Material; Torn Material
IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE, UPON REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE IN THE FEMORAL ARTERY; THEREFORE, THE GRAFT WAS SHORTENED AND THE ANASTOMOSIS WAS COMPLETED WITH THE REMAINDER OF THE GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6187549 ↗MalfunctionSep 19, 2016Torn Material; Torn Material
IT WAS REPORTED THAT THE VASCULAR BYPASS GRAFT ALLEGEDLY TORE DURING IMPLANTATION IN THE FEMORAL POPLITEAL ARTERY. REPORTEDLY, ANOTHER GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5960366 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER devices
- ADVANTA SLIDER GDS 22115Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22116Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall1 report
- ADVANTA SLIDER GDS 22267Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22011Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22061Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22016Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- IMPRA® ePTFE Vascular Grafts F8006TWSCBard Peripheral Vascular, Inc. · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER7 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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