AlboGraft Polyester Vascular Graft AMC1407Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840663103430), received between May 5, 2016 and Sep 2, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING AN INFRARENAL AORTIC REPLACEMENT, AFTER COMPLETING PROXIMAL ANASTOMOSIS, THE SURGEON OBSERVED A DEFECT IN THE Y SECTION OF THE GRAFT. HE OBSERVED A HOLE IN BETWEEN THE TWO BIFURCATES. IT WAS ABOUT 1 MM WITH A VISIBLE MESH DEFECT. THE HOLE WAS CLOSED WITH A SUTURE. NO OTHER DEFECTS WERE PRESENT IN THE GRAFT. THERE WAS NO HARM TO THE USER OR THE PATIENT BECAUSE OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416062 ↗
• InjuryApr 22, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING PROCEDURE, AFTER COMPLETING DISTAL ANASTOMOSIS, SURGEON OBSERVED A SMALL HOLE IN ONE OF THE BIFURCATED LEG WHEN FLUSHING IT WITH SALINE. THE SECTION OF THE GRAFT WITH THE HOLE WAS DISCARDED. THERE WAS NO HARM TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711245 ↗
• MalfunctionAug 10, 2017Leak/Splash; Leak/Splash

  DURING TREATMENT OF PATIENT WITH ABNORMAL AORTIC ANEURYSM, ALBOGRAFT WAS IMPLANTED. AFTER UNCLAMPING AT THE AORTA, THE GRAFT STARTED OOZING BLOOD. PATIENT HAD BEEN TREATED WITH STANDARD LOAD OF HEPARIN. AFTER 10 MINUTES OF IMPLANTATION, BLEEDING STOPPED. GRAFT REMAINS IMPLANTED IN THE PATIENT WITH NO CLINICAL SEQUELAE.

  Patient problems: Aneurysm

  MAUDE report 6785741 ↗
• MalfunctionMar 1, 2017Leak/Splash; Leak/Splash

  THE SURGEON COMMENTED THAT WHEN HE UNCLAMPED, HE FOUND THE BLOOD LEAKING FROM THE BODY OF THE ALBOGRAFT.

  Patient problems: Blood Loss

  MAUDE report 6369965 ↗
• MalfunctionFeb 10, 2017Leak/Splash; Leak/Splash

  THE SURGEON FOUND BLOOD LEAKAGE AT THE BODY OF THE ALBOGRAFT WHEN HE UNCLAMPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6324269 ↗
• MalfunctionMay 5, 2016Device Issue; Device Issue

  DURING IMPLANTATION THE PHYSICIAN NOTICED A "JELLY" MATERIAL STUCK TO THE WALLS OF THE GRAFT'S LEG. IT CAME OFF WHEN THE PHYSICIAN TAPERED THE GRAFT'S LEG WITH SCISSORS. THE GRAFT WAS IMPLANTED AND REMAINS IMPLANTED. A SMALL PORTION OF THE GRAFT WAS CUT AND RETURNED FOR EVALUATION. THE PHYSICIAN NOTED THAT THIS OBSERVATION DID NOT AFFECT THE OUTCOME OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5635183 ↗