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LifeSpan ePTFE Vascular Graft

Model R10080 · Lemaitre Vascular, Inc. · DI 00840663105403

DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · Class II · 21 CFR 870.3450

UDILibrary device dossier · generated 2026-09-11 · 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 2.43/device2019-02: 0 reports for this device; peer average 3.17/device2019-03: 0 reports for this device; peer average 2.38/device2019-04: 0 reports for this device; peer average 2.71/device2019-05: 0 reports for this device; peer average 2.2/device2019-06: 0 reports for this device; peer average 1.83/device2019-07: 0 reports for this device; peer average 2.06/device2019-08: 0 reports for this device; peer average 5.89/device2019-09: 0 reports for this device; peer average 2.27/device2019-10: 0 reports for this device; peer average 3.87/device2019-11: 0 reports for this device; peer average 3.75/device2019-12: 0 reports for this device; peer average 3.25/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2.17/device2020-03: 0 reports for this device; peer average 3.43/device2020-04: 0 reports for this device; peer average 2.43/device2020-05: 0 reports for this device; peer average 4.29/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 2.67/device2020-08: 0 reports for this device; peer average 2.13/device2020-09: 0 reports for this device; peer average 2.25/device2020-10: 0 reports for this device; peer average 2.67/device2020-11: 0 reports for this device; peer average 2.69/device2020-12: 0 reports for this device; peer average 2.54/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 2.67/device2021-03: 0 reports for this device; peer average 2.13/device2021-04: 0 reports for this device; peer average 2.09/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 3.23/device2021-07: 0 reports for this device; peer average 4.67/device2021-08: 0 reports for this device; peer average 1.83/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 2.67/device2021-11: 0 reports for this device; peer average 2.13/device2021-12: 0 reports for this device; peer average 3.11/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2.8/device2022-03: 0 reports for this device; peer average 4.14/device2022-04: 0 reports for this device; peer average 2.7/device2022-05: 0 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 4.5/device2022-07: 0 reports for this device; peer average 1.88/device2022-08: 0 reports for this device; peer average 2.86/device2022-09: 0 reports for this device; peer average 2.4/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 4/device2022-12: 0 reports for this device; peer average 4/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 3.29/device2023-03: 0 reports for this device; peer average 4.5/device2023-04: 0 reports for this device; peer average 3.83/device2023-05: 0 reports for this device; peer average 3.5/device2023-06: 0 reports for this device; peer average 3.4/device2023-07: 0 reports for this device; peer average 4.36/device2023-08: 0 reports for this device; peer average 2.79/device2023-09: 0 reports for this device; peer average 3/device2023-10: 0 reports for this device; peer average 2.25/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 2.4/device2024-01: 0 reports for this device; peer average 5/device2024-02: 0 reports for this device; peer average 4.43/device2024-03: 0 reports for this device; peer average 2.38/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2.17/device2024-06: 0 reports for this device; peer average 4/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1.83/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1.5/device2024-12: 0 reports for this device; peer average 2.14/device2025-01: 0 reports for this device; peer average 2.36/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2.5/device2025-05: 0 reports for this device; peer average 3.71/device2025-06: 0 reports for this device; peer average 1.78/device2025-07: 0 reports for this device; peer average 4.57/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 3/device2025-11: 0 reports for this device; peer average 2.75/device2025-12: 0 reports for this device; peer average 2.5/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 1.8/device2026-03: 0 reports for this device; peer average 3.35/device2026-04: 0 reports for this device; peer average 7.33/device2026-05: 0 reports for this device; peer average 3.44/device2026-06: 0 reports for this device; peer average 4.2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.43
2019-0203.17
2019-0302.38
2019-0402.71
2019-0502.2
2019-0601.83
2019-0702.06
2019-0805.89
2019-0902.27
2019-1003.87
2019-1103.75
2019-1203.25
2020-0103
2020-0202.17
2020-0303.43
2020-0402.43
2020-0504.29
2020-0603
2020-0702.67
2020-0802.13
2020-0902.25
2020-1002.67
2020-1102.69
2020-1202.54
2021-0102
2021-0202.67
2021-0302.13
2021-0402.09
2021-0502
2021-0603.23
2021-0704.67
2021-0801.83
2021-0903
2021-1002.67
2021-1102.13
2021-1203.11
2022-0102
2022-0202.8
2022-0304.14
2022-0402.7
2022-0502.5
2022-0604.5
2022-0701.88
2022-0802.86
2022-0902.4
2022-1003
2022-1104
2022-1204
2023-0102.5
2023-0203.29
2023-0304.5
2023-0403.83
2023-0503.5
2023-0603.4
2023-0704.36
2023-0802.79
2023-0903
2023-1002.25
2023-1102
2023-1202.4
2024-0105
2024-0204.43
2024-0302.38
2024-0402
2024-0502.17
2024-0604
2024-0702
2024-0801.83
2024-0901.5
2024-1002
2024-1101.5
2024-1202.14
2025-0102.36
2025-0201
2025-0302
2025-0402.5
2025-0503.71
2025-0601.78
2025-0704.57
2025-0802
2025-0901
2025-1003
2025-1102.75
2025-1202.5
2026-0101.5
2026-0201.8
2026-0303.35
2026-0407.33
2026-0503.44
2026-0604.2
This device (reports/month)Average device in DSY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K130016 — cites (transitively): K032900 (d1), K933590 (d1), K944844 (d1), K944858 (d1)

Lineage extracted from public 510(k) summary text (heuristic).

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