AlboGraft Polyester Vascular Graft AMC2010Recalls & reported problems
Lemaitre Vascular, Inc. · AlboGraft Polyester Vascular Graft 20cmx10mm · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840663103492), received between Dec 15, 2017 and May 16, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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
- Fluid/Blood Leak2
Patient problems
- Aneurysm1
- Blood Loss1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2018Fluid/Blood Leak; Fluid/Blood Leak
DURING ABDOMINAL ANEURYSM REPAIR, AFTER THE ANASTOMOSIS WAS PERFORMED DISTALLY AND THE AORTIC CLAMP WAS REMOVED, THE BLOOD LEAKED THROUGH THE ENTIRE LENGTH OF THE GRAFT.
Patient problems: Blood Loss
MAUDE report 7519388 ↗InjuryDec 15, 2017Fluid/Blood Leak; Fluid/Blood Leak
ALBOGRAFT VASCULAR GRAFT AMC2010 LOT# 140129 SERIAL NUMBER (B)(4) WAS USED DURING OPEN AORTA ANEURISM TREATMENT. AFTER PERFORMING PROXIMAL ANASTOMOSIS, THE GRAFT START TO BLEED WHEN THE CLAMP WAS REMOVED. SO, ANOTHER LEMAITRE ALBOGRAFT WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Aneurysm
MAUDE report 7123279 ↗
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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