IMPRA® ePTFE Vascular Grafts F7008TWSRecalls & reported problems
Bard Peripheral Vascular, Inc. · IMPRA® ePTFE Vascular Graft, Flex™ Thinwall Small Beading, 8 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741023279), received between Jan 12, 2017 and Jul 11, 2019 — classified as 5 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 Patient Involvement5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE EVENTS INDICATED THAT MODEL F7008TWS EPTFE VASCULAR GRAFT EXPERIENCED SPLIT, CUT, OR TORN MATERIAL. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. BOTH DEVICES DID NOT INVOLVE PATIENTS. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8783144 ↗MalfunctionJan 13, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PREPARATION, UPON REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6250045 ↗MalfunctionJan 13, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PREPARATION, UPON REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6250040 ↗MalfunctionJan 12, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PREPARATION, UPON REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6248094 ↗MalfunctionJan 12, 2017Torn Material; Torn Material
IT WAS REPORTED THAT DURING PREPARATION, UPON REMOVAL OF THE BEADING FROM THE VASCULAR GRAFT, THE GRAFT ALLEGEDLY TORE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6248033 ↗
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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