IMPRA® ePTFE Vascular Grafts F5008TWSCRecalls & reported problems
Bard Peripheral Vascular, Inc. · IMPRA® ePTFE Vascular Graft, Carboflo® Flex Thinwall Small Beading Carbon-Lined, 8 mm x 50 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741021565), received between Nov 22, 2017 and Feb 9, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn2
- Torn Material2
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT UPON REMOVAL OF C-ARM AFTER SURGICAL GRAFT IMPLANTATION PROCEDURE IN EXTERNAL ILIAC ARTERY, PROSTHESIS WAS ALLEGEDLY TORN. IT WAS FURTHER REPORTED THAT TORN PART WAS SUTURED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16331508 ↗MalfunctionAug 7, 2018Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT 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 AND THE REMAINDER OF THE GRAFT WAS SUTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7760107 ↗MalfunctionNov 22, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING IMPLANTATION OF THE EPTFE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE DURING BEADING REMOVAL. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7053741 ↗MalfunctionNov 22, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING IMPLANTATION OF THE EPTFE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE DURING BEADING REMOVAL. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER REMOVED THE SEGMENT OF TORN GRAFT MATERIAL AND COMPLETED THE PROCEDURE WITH THE REMAINING LENGTH OF THE GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7053585 ↗
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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