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AlboGraft Polyester Vascular Graft

Model AMC4024 · Lemaitre Vascular, Inc. · DI 00840663110445

MAL — Graft, Vascular, Synthetic/Biologic Composite · Class II · 21 CFR 870.3450

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

24572019-01: 0 reports for this device; peer average 3/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 3/device2019-04: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 6/device2019-10: 0 reports for this device; peer average 5.33/device2019-11: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 6/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 4.8/device2020-08: 0 reports for this device; peer average 3/device2020-11: 0 reports for this device; peer average 2.67/device2021-01: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 4.5/device2021-05: 0 reports for this device; peer average 6.75/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2.67/device2021-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 3/device2022-01: 0 reports for this device; peer average 4.5/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 4.5/device2022-05: 0 reports for this device; peer average 6/device2022-06: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 3.6/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 6/device2023-04: 0 reports for this device; peer average 3/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 3/device2023-09: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 6/device2023-12: 0 reports for this device; peer average 6/device2024-05: 0 reports for this device; peer average 6/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 3.5/device2024-10: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 3.5/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 3/device2025-07: 0 reports for this device; peer average 7/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 4/device2025-10: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 2.5/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 6/device2026-06: 0 reports for this device; peer average 6/device010203040607091011010204060708110104050607080910111201020305060910010203040506091112050607100405060708091012010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0203
2019-0303
2019-0403
2019-0603
2019-0703
2019-0906
2019-1005.33
2019-1103
2020-0101
2020-0203
2020-0406
2020-0603
2020-0704.8
2020-0803
2020-1102.67
2021-0103
2021-0404.5
2021-0506.75
2021-0602
2021-0702.67
2021-0803
2021-0903
2021-1003
2021-1103
2021-1203
2022-0104.5
2022-0203
2022-0304.5
2022-0506
2022-0603
2022-0903
2022-1003.6
2023-0102
2023-0203
2023-0306
2023-0403
2023-0503
2023-0603
2023-0902
2023-1106
2023-1206
2024-0506
2024-0602
2024-0703.5
2024-1003
2025-0403.5
2025-0503
2025-0603
2025-0707
2025-0801.5
2025-0904
2025-1003
2025-1203
2026-0102.5
2026-0202
2026-0303
2026-0403
2026-0506
2026-0606
This device (reports/month)Average device in MAL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Lemaitre Vascular, Inc.

  • Warning Letter 2025-08-11 LeMaitre Vascular, Inc.
  • Warning Letter 2025-08-11 LeMaitre Vascular, Inc.
  • Warning Letter 2010-05-11 LeMaitre Vascular, Inc.
  • Warning Letter 2010-05-11 LeMaitre Vascular, Inc.
  • OAI 2025-04-16 LeMaitre Vascular, Inc. · 8 citations
  • OAI 2025-04-16 LeMaitre Vascular, Inc. · 8 citations
  • VAI 2023-05-16 LeMaitre Vascular, Inc. · 1 citations
  • VAI 2023-05-16 LeMaitre Vascular, Inc. · 1 citations
  • VAI 2023-04-13 LeMaitre Vascular, Inc. · 4 citations
  • VAI 2023-04-13 LeMaitre Vascular, Inc. · 4 citations
  • VAI 2022-06-15 LeMaitre Vascular, Inc. · 5 citations
  • VAI 2022-06-15 LeMaitre Vascular, Inc. · 5 citations
  • NAI 2020-08-27 LeMaitre Vascular, Inc. · 0 citations
  • NAI 2020-08-27 LeMaitre Vascular, Inc. · 0 citations
  • NAI 2018-02-16 LeMaitre Vascular, Inc. · 0 citations
  • NAI 2018-02-16 LeMaitre Vascular, Inc. · 0 citations
  • NAI 2017-08-01 LeMaitre Vascular, Inc. · 0 citations
  • NAI 2017-08-01 LeMaitre Vascular, Inc. · 0 citations
  • VAI 2015-01-28 LeMaitre Vascular, Inc. · 5 citations
  • VAI 2015-01-28 LeMaitre Vascular, Inc. · 5 citations
  • VAI 2013-03-04 LeMaitre Vascular, Inc. · 3 citations
  • VAI 2013-03-04 LeMaitre Vascular, Inc. · 3 citations
  • NAI 2013-01-25 LeMaitre Vascular, Inc. · 0 citations
  • NAI 2013-01-25 LeMaitre Vascular, Inc. · 0 citations