MAXIFLO™ T8008ERecalls & reported problems
Vascutek Ltd · MAXIFLO ePTFE Vascular Prosthesis ULTRATHIN Wrap with Unity Construction · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881151380), received between Jul 4, 2019 and Jul 4, 2019 — classified as 3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Split, Cut or Torn3
Patient problems
- No Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 4, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT IS BEING SUBMITTED AS FOLLOW UP # 1 FOR MFR. REPORT # 9612515-2019-00014 TO PROVIDE CLOSURE INFORMATION FOR THE CASE.
Patient problems: No Information
MAUDE report 8762624 ↗MalfunctionJul 4, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT IS BEING SUBMITTED AS FOLLOW UP # 1 FOR MFR. REPORT # 9612515-2019-00016 TO PROVIDE CLOSURE INFORMATION FOR THE CASE.
Patient problems: No Information
MAUDE report 8762623 ↗MalfunctionJul 4, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THIS REPORT IS BEING SUBMITTED AS FOLLOW UP # 1 FOR MFR. REPORT # 9612515-2019-00017 TO PROVIDE CLOSURE INFORMATION FOR THE CASE.
Patient problems: No Information
MAUDE report 8762621 ↗
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
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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