AlboGraft Polyester Vascular Graft ATC2211Recalls & reported problems
Lemaitre Vascular, Inc. · AlboGraft Polyester Vascular Graft 22cmx11 · 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 00840663104239), received between Sep 20, 2022 and Sep 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1
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.
MalfunctionSep 20, 2022Material Puncture/Hole; Material Puncture/Hole
AN IMPLANT OF ALBOGRAFT AMC3008 FOR BYPASS WAS IN PROCESS. AT THE DISTAL PART OF THE GRAFT, THEY FOUND A SMALL HOLE. THIS PART WAS NOT AIMED TO BE USED, SO IT WAS CUT OFF AND WAS NOT USED. CONCLUSION A SMALL HOLE IN THE GRAFT WAS RECOGNIZED, BUT IT WAS NOT IN CONTACT OR BEEN USED IN THE PATIENT. THE GRAFT WAS DISCARDED BY THE HOSPITAL. THERE WAS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15456844 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page