IMPRA® ePTFE Vascular Grafts F8008TWSCRecalls & reported problems
Bard Peripheral Vascular, Inc. · IMPRA® ePTFE Vascular Graft, Carboflo® Flex Thinwall Small Beading Carbon-Lined, 8 mm x 80 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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741021640), received between Jan 17, 2017 and Dec 14, 2022 — classified as 1 injury, 4 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 Torn1
Patient problems
- No Consequences Or Impact To Patient3
- Hematoma1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
LOG. IT WAS REPORTED THAT DURING SURGICAL GRAFT PLACEMENT PROCEDURE, THE GRAFT WAS ALLEGEDLY TORN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15975732 ↗MalfunctionSep 8, 2017Torn Material; Torn Material
IT WAS REPORTED DURING AN INTRAOPERATIVE PROCEDURE, AN ALLEGED TEAR IN THE VASCULAR GRAFT WAS IDENTIFIED UPON REMOVAL OF THE 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 6853425 ↗MalfunctionMay 30, 2017Torn Material; Torn Material
IT WAS REPORTED THAT AFTER SUTURING THE FIRST VESSEL DURING A CROSS OVER BYPASS PROCEDURE, THE PHYSICIAN WAS REMOVING THE STABILIZING SPIRAL AND NOTED TEARS/HOLES IN THE VASCULAR GRAFT. THE GRAFT WAS REMOVED AND ANOTHER GRAFT WAS SUCCESSFULLY PREPPED AND SUTURED IN PLACE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6598719 ↗MalfunctionMar 21, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE, UPON REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6423276 ↗InjuryJan 17, 2017Torn Material; Torn Material
IT WAS REPORTED THAT A FEMORAL SURGICAL GRAFT WAS SUCCESSFULLY SUTURED IN A PERPENDICULAR PLACEMENT TO AN EXISTING FEMORAL SURGICAL GRAFT. WHILE MOVING THE PATIENT OFF THE SURGICAL TABLE A HEMATOMA WAS IDENTIFIED AT THE ANASTOMOSIS OF THE SURGICAL GRAFT PLACEMENT. A REVISION OF THE LEAKING SURGICAL GRAFT WAS PERFORMED AT THE ANASTOMOSIS OF THE GRAFT TO GRAFT PLACEMENT. THE PATIENT WAS ADMITTED TO HOSPITAL EIGHT DAYS POST SURGICAL GRAFT PLACEMENT FOR BLEEDING AT THE ANASTOMOSIS OF THE GRAFT TO GRAFT PLACEMENT. A REVISION OF THE SURGICAL GRAFT WAS PERFORMED. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Hematoma
MAUDE report 6258990 ↗
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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