Distaflo® Bypass Grafts DF7007SCRecalls & reported problems
Bard Peripheral Vascular, Inc. · Distaflo® Bypass Graft With Flex Small Beading Standard Cuff, 7 mm x 70 cm · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741023576), received between Sep 8, 2017 and Dec 7, 2020 — classified as 3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Torn Material2
- Material Split, Cut or Torn1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING GRAFT PLACEMENT PROCEDURE, THE GRAFT ALLEGEDLY TORN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10957796 ↗MalfunctionDec 6, 2017Torn Material; Torn Material
IT WAS REPORTED THAT PRIOR TO PLACEMENT OF THE EPTFE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE UPON REMOVAL OF THE SPIRAL BEADING. REPORTEDLY, ANOTHER VASCULAR GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 7088517 ↗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 6853775 ↗
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 22061Atrium 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 22267Atrium 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
- ADVANTA SLIDER GDS 22058Atrium 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.