IMPRA® ePTFE Vascular Grafts F7006TWSCRecalls & reported problems
Bard Peripheral Vascular, Inc. · IMPRA® ePTFE Vascular Graft, Carboflo® Flex Thinwall Small Beading Carbon-Lined, 6 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741021596), received between Jun 19, 2017 and Oct 15, 2025 — classified as 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
- Torn Material3
Patient problems
- No Consequences Or Impact To Patient4
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PATIENT WAS GETTING PREPARED FOR A SURGICAL GRAFT PLACEMENT PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE MATERIAL TORE REPEATEDLY WHILE STITCHING. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23298301 ↗MalfunctionOct 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL F7006TWSC, VASCULAR GRAFT, ALLEGEDLY HAD CUTS IN THE MATERIAL. A PATIENT WAS INVOLVED WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER ARE UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9215220 ↗MalfunctionJul 11, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL F7006TWSC EPTFE VASCULAR GRAFTS ALLEGEDLY EXPERIENCED MATERIAL BEING SPLIT, CUT OR TORN. THIS REPORT WAS RECEIVED FROM VARIOUS SOURCES. OF THE TWO ALLEGED INCIDENCES OF MATERIAL BEING SPLIT, CUT OR TORN, NEITHER INVOLVED PATIENTS AS THERE WAS NO PATIENT CONTACT. THE PATIENTS AGES AND WEIGHTS WERE NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8783029 ↗MalfunctionJul 14, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PREPARATION OF A SURGICAL GRAFT, A TEAR IN THE GRAFT OCCURRED WHILE REMOVING THE BEADING. A NEW SURGICAL GRAFT WAS PREPPED AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6715014 ↗MalfunctionJul 14, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PREPARATION OF A SURGICAL GRAFT, A TEAR IN THE GRAFT OCCURRED WHILE REMOVING THE BEADING. A NEW SURGICAL GRAFT WAS PREPPED AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6715011 ↗MalfunctionJun 19, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PREPARATION OF A SURGICAL GRAFT, A TEAR IN THE GRAFT OCCURRED WHILE REMOVING THE BEADING. A NEW SURGICAL GRAFT WAS PREPPED AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 6652610 ↗
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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