AlboGraft Polyester Vascular Graft ATC1520Recalls & reported problems
Lemaitre Vascular, Inc. · AlboGraft Polyester Vascular Graft 15cmx20mm · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663103867), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated at the User Facility” (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
- Device Contaminated at the User Facility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2023Device Contaminated at the User Facility; Device Contaminated at the User Facility
DURING A MEETING WITH THE SWEDISH MOH WE WERE INFORMED OF AN INCIDENT WHERE WHILE PREPARING THE ALBOGRAFT, THE NURSE OVERLOOKED THE LABELS ON THE PACKAGING AND INTRODUCED THE NON-STERILE PACKAGING INTO THE STERILE FIELD. THE STATUS OF THE PATIENT IS UNKNOWN. THE NURSE DID NOT REPORT THE EVENT AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16762228 ↗
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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