IMPRA® ePTFE Vascular Grafts F5006CRecalls & reported problems
Bard Peripheral Vascular, Inc. · IMPRA® ePTFE Vascular Graft, Carboflo® Flex Carbon-Lined, 6 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741021350), received between May 20, 2021 and Mar 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Leak/Splash1
- Material Split, Cut or Torn1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Fluid/Blood Leak; Leak/Splash; Peeled/Delaminated; Material Split, Cut or Torn
ON (B)(6) 2026, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING A CARBOFLO DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE RING ON THE GRAFT ALLEGEDLY FELL OFF, CAUSING THE BLOOD TO LEAK FROM THE GRAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24554738 ↗MalfunctionMay 20, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11853714 ↗
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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