IMPRA® ePTFE Vascular Grafts F7007TWSCRecalls & reported problems
Bard Peripheral Vascular, Inc. · IMPRA® ePTFE Vascular Graft, Carboflo® Flex Thinwall Small Beading Carbon-Lined, 7 mm x 70 cm · Class 2 · Implant
All models of IMPRA ePTFE Vascular Grafts (52)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00801741021602), received between Sep 12, 2016 and Jun 20, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Torn Material” (3 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 Material3
Patient problems
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING A DEMONSTRATION FOR REMOVAL OF BEADING ON A SURGICAL GRAFT, THE GRAFT TORE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6654400 ↗MalfunctionJun 19, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING A SURGICAL GRAFT IMPLANT, THE GRAFT TORE WHEN THE BEADING WAS REMOVED. ANOTHER SURGICAL GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6652554 ↗MalfunctionSep 12, 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. REPORTEDLY, ANOTHER VASCULAR GRAFT WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5943215 ↗
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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