IMPRA® ePTFE Vascular Grafts F8006TWSCRecalls & reported problems
Bard Peripheral Vascular, Inc. · IMPRA® ePTFE Vascular Graft, Carboflo® Flex Thinwall Small Beading Carbon-Lined, 6 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
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741021626), received between Oct 26, 2016 and Dec 11, 2025 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn3
- Improper or Incorrect Procedure or Method2
- Separation Failure2
- Torn Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Improper or Incorrect Procedure or Method; Separation Failure; Improper or Incorrect Procedure or Method; Separation Failure
ON (B)(6) 2025, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING THE CARBOFLO. DURING THE PROCEDURE THE CLINICIAN WAS UNABLE TO REMOVE THE SPIRAL BEADING FROM GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776878 ↗MalfunctionDec 11, 2025Improper or Incorrect Procedure or Method; Separation Failure; Improper or Incorrect Procedure or Method; Separation Failure
ON (B)(6) 2025, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING THE CARBOFLO. DURING THE PROCEDURE THE CLINICIAN WAS UNABLE TO REMOVE THE SPIRAL BEADING FROM GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776876 ↗MalfunctionJun 30, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING THE PROCEDURE THROUGH RIGHT FEMORAL-POPLITEAL BYPASS, THE FRAMEWORK OF THE DEVICE ALLEGEDLY DETACHED WHEN THE SURGEON TOOK IT IN THE HAND. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12093815 ↗MalfunctionNov 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE GRAFT ALLEGEDLY HAD A HOLE WHILE REMOVING THE OUTER PROTECTIVE RING. IT WAS FURTHER REPORTED THAT THE HCP SUTURED THE HOLE AND CLOSED BEFORE IMPLANTING THE GRAFT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10917799 ↗MalfunctionJul 6, 2018Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING IMPLANTATION OF THE EPTFE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE DURING BEADING REMOVAL. IT WAS FURTHER REPORTED THAT ANOTHER VASCULAR GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7667148 ↗InjuryOct 3, 2017Torn Material; Torn Material
IT WAS REPORTED THAT FIVE WEEKS POST IMPLANT OF A VASCULAR GRAFT FOR AN AXILLO-FEMORAL BYPASS PROCEDURE, THE PATIENT ALLEGEDLY HAD PAIN. A CT ANGIOGRAM REVEALED THAT THERE WAS A FIVE CENTIMETER SEPARATION BETWEEN THE TORN GRAFT. ANOTHER VASCULAR GRAFT WAS PLACED TO CONNECT THE TWO ENDS OF THE GRAFT.
Patient problems: Pain
MAUDE report 6909737 ↗MalfunctionOct 26, 2016Torn Material; Torn Material
IT WAS REPORTED THAT AFTER IMPLANTATION OF THE VASCULAR GRAFT AN ALLEGED SPLIT WAS IDENTIFIED APPROXIMATELY ¾ OF THE WAY DOWN FROM THE SUTURE SITE; THEREFORE, THE TORN SECTION OF THE GRAFT WAS CUT AND REMOVED. IT WAS FURTHER REPORTED THAT THE REMAINDER OF THE GRAFT WAS RE SUTURED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6059392 ↗
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 F7006TWSCBard Peripheral Vascular, Inc. · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER6 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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