AlboGraft Polyester Vascular GraftRecalls & reported problems across all models

We found 11 models of AlboGraft Polyester Vascular Graft by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between May 5, 2016 and Jul 17, 2024 — classified as 10 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AlboGraft Polyester Vascular Graft problems

AlboGraft Polyester Vascular Graft models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AlboGraft Polyester Vascular Graft AMC1407

  Graft, Vascular, Synthetic/Biologic Composite
  6 reports
• AlboGraft Polyester Vascular Graft AMC1608

  Graft, Vascular, Synthetic/Biologic Composite
  4 reports
• AlboGraft Polyester Vascular Graft AMC3006

  Graft, Vascular, Synthetic/Biologic Composite
  2 reports
• AlboGraft Polyester Vascular Graft AMC1207

  Graft, Vascular, Synthetic/Biologic Composite
  2 reports
• AlboGraft Polyester Vascular Graft AMC2010

  Graft, Vascular, Synthetic/Biologic Composite
  2 reports
• AlboGraft Polyester Vascular Graft AMC4008

  Graft, Vascular, Synthetic/Biologic Composite
  1 report
• AlboGraft Polyester Vascular Graft AMC1809

  Graft, Vascular, Synthetic/Biologic Composite
  1 report
• AlboGraft Polyester Vascular Graft ATC1520

  Graft, Vascular, Synthetic/Biologic Composite
  1 report
• AlboGraft Polyester Vascular Graft ATC3028

  Graft, Vascular, Synthetic/Biologic Composite
  1 report
• AlboGraft Polyester Vascular Graft ATC2211

  Graft, Vascular, Synthetic/Biologic Composite
  1 report
• AlboGraft Polyester Vascular Graft ATC3036

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report

Recent AlboGraft Polyester Vascular Graft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2024Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE MATERIAL OF THE GRAFT STARTED TO DISINTEGRATE AS THE SUTURE WENT THROUGH IT; FURTHER SUTURING MADE THE GRAFT DISINTEGRATE MORE. ANOTHER GRAFT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761147 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PROSTHESIS THROMBOSIS. FEM-POP ARTERIAL BYPASS. NEED OF ANOTHER SURGERY TO REPLACE IT.

  Patient problems: Insufficient Information

  MAUDE report 10795871 ↗
• InjuryNov 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PROSTHESIS THROMBOSIS. FEM-POP ARTERIAL BYPASS. NEED OF ANOTHER SURGERY TO REPLACE IT.

  Patient problems: Insufficient Information

  MAUDE report 10795852 ↗
• InjuryAug 14, 2020Material Rupture; Material Rupture

  SPONTANEOUS VERTICAL RUPTURE OF THE GRAFT IN THE AREA OF THE PROXIMAL UPPER THIRD IN LENGTH, AWAY FROM THE ANASTOMOSIS.

  Patient problems: Failure of Implant

  MAUDE report 10408881 ↗
• 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 ↗
• MalfunctionOct 10, 2018Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  DURING CAROTID ENDARTERECTOMY, THE INTERNAL CAROTID BALLOON FAILED TO INFLATE PROPERLY. AS A RESULT, BLOOD WAS LEAKING OUT FROM THE PATIENT'S VESSEL DURING ANASTOMOSIS SINCE THE BALLOON WAS UNABLE TO COMPLETELY OCCLUDE THE ARTERY. THIS IS A FOLLOW-UP REPORT OF MANUFACTURER'S INCIDENT REPORT 1220948-2018-00059 THAT WAS INITIALLY PROVIDED ON (B)(6) 2018.

  Patient problems: Aneurysm

  MAUDE report 7952761 ↗
• MalfunctionMay 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  BLOOD WAS OOZING FROM LEFT LIMB OF THE GRAFT NEAR THE SITE OF BIFURCATION ONCE THE SUPPORTING CLAMP WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7523406 ↗
• 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 ↗

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