AlboGraft Polyester Vascular Graft AMC1608Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840663103454), received between Jun 17, 2016 and Jun 26, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ALBOGRAFT WALL WAS LEAKING AFTER BEING CLOSED WITH SUTURES FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. LEAKAGE OCCURRED FROM THE GRAFT RESULTING IN LONGER OPERATION TIME AND BLOOD LOSS. AN ALTERNATE GRAFT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATION OR INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19617006 ↗
• InjuryJun 10, 2020Material Puncture/Hole; Material Puncture/Hole

  INTRAOPERATIVELY, A HOLE WAS NOTICED IN THE GRAFT. THE HOLE WAS 3-4MM IN SIZE. ON ONE PICTURE IS A 1.2MM DULL- HEADED CANNULA IN THE HOLE OF THE GRAFT. THE HOLE WAS SEWN OVER. THE PATIENT WAS STILL IN THE OPERATION ROOM, WHEN THEY CALLED US. THERE WAS NO IMPACT ON PATIENT'S HEALTH AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138111 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem

  A FEW YEARS AGO ( EXACT DATE UNKNOWN), A PATIENT RECEIVED A BIFURCATED AORTIC PROSTHESIS ( FROM A DIFFERENT MANUFACTURER ). THE PATIENT WAS DIAGNOSED WITH A PERIGRAFT SEROMA FROM THIS GRAFT. ON (B)(6) 2017, THE PROSTHESIS WAS REPLACED WITH AN ALBOGRAFT PROSTHESIS ( CATALOG# AMC1608; LOT# 180381 SERIAL NUMBER# (B)(4)). THE PATIENT HAD AN ALLERGIC REACTION TO THIS GRAFT AS WELL. SO, THE PATIENT WAS TREATED FOR AN ALLERGIC REACTION. THE PATIENT RESPONDED WELL TO MEDICATION. HOWEVER, SINCE THE BEGINNING OF (B)(6) 2018, THE PATIENT DID NOT RESPOND WELL TO THE PRESCRIBED MEDICATION. A BLOOD TEST CONDUCTED ON THE PATIENT'S BLOOD SAMPLE DETECTED PRESENCE OF METHY- PROPYL-4-HYDROXYBENZOATE.

  Patient problems: Irritation

  MAUDE report 8162158 ↗
• InjuryJun 17, 2016Leak/Splash; Leak/Splash

  THE GRAFT WAS LEAKING DURING THE IMPLANTATION. THE PHYSICIAN HAD TO USE THE BLOOD CIRCULATING MACHINE FOR BLOOD TRANSFUSION (ABOUT 800 CC). THE BLEEDING WAS STOPPED WITH CELLULOSE WADDING. THE GRAFT REMAINS IMPLANTED. PATIENT IS OKAY.

  Patient problems: Blood Loss

  MAUDE report 5732537 ↗