AlboGraft Polyester Vascular Graft AMC4008Recalls & reported problems
Lemaitre Vascular, Inc. · AlboGraft Polyester Vascular Graft 40cmx8mm · Class 2 · Implant
All models of AlboGraft Polyester Vascular Graft (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663102891), received between Aug 14, 2020 and Aug 14, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (1 report).
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
- Material Rupture1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2020Material Rupture; Material Rupture
SPONTANEOUS VERTICAL RUPTURE OF THE GRAFT IN THE AREA OF THE PROXIMAL UPPER THIRD IN LENGTH, AWAY FROM THE ANASTOMOSIS.
Patient problems: Failure of Implant
MAUDE report 10408881 ↗
Other Graft, Vascular, Synthetic/Biologic Composite devices
- Hemashield M00202166168P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall3 reports
- Hemashield M002020851890Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall2 reports
- Hemashield M002020952070Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite1 recall0 reports
- Hemashield M00202175928P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite10 reports
- Hemashield M00202175210P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite8 reports
- Hemashield M00202175208P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite8 reports
- AlboGraft Polyester Vascular Graft AMC1407Lemaitre Vascular, Inc. · Graft, Vascular, Synthetic/Biologic Composite6 reports
- Hemashield M00202175430P0Intervascular Sas · Graft, Vascular, Synthetic/Biologic Composite6 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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