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Acculink™

Model 1011344-40 · ABBOTT VASCULAR INC. · DI 08717648076398

NIM — Stent, Carotid · Class III

UDILibrary device dossier · generated 2026-09-12 · 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 (64)

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.

Malfunction: 45 · Injury: 19

23562019-01: 0 reports for this device; peer average 1.5/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.75/device2019-04: 0 reports for this device; peer average 3/device2019-05: 0 reports for this device; peer average 2.67/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2.88/device2019-08: 0 reports for this device; peer average 2.25/device2019-09: 2 reports for this device; peer average 2.83/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 2.67/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 3.25/device2020-02: 0 reports for this device; peer average 3.5/device2020-03: 0 reports for this device; peer average 2.67/device2020-04: 0 reports for this device; peer average 2.25/device2020-05: 3 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.2/device2020-07: 0 reports for this device; peer average 4.5/device2020-08: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 3.25/device2020-10: 0 reports for this device; peer average 3/device2020-11: 3 reports for this device; peer average 2.44/device2020-12: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 3/device2021-02: 6 reports for this device; peer average 5/device2021-03: 0 reports for this device; peer average 4.33/device2021-04: 0 reports for this device; peer average 3.14/device2021-05: 0 reports for this device; peer average 2.6/device2021-06: 0 reports for this device; peer average 3.6/device2021-07: 0 reports for this device; peer average 4/device2021-08: 3 reports for this device; peer average 2.6/device2021-09: 0 reports for this device; peer average 2.5/device2021-10: 3 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 3/device2021-12: 3 reports for this device; peer average 2.2/device2022-01: 0 reports for this device; peer average 3/device2022-02: 0 reports for this device; peer average 2.82/device2022-03: 0 reports for this device; peer average 6/device2022-04: 0 reports for this device; peer average 3/device2022-05: 3 reports for this device; peer average 3.5/device2022-06: 3 reports for this device; peer average 2.78/device2022-07: 3 reports for this device; peer average 3.17/device2022-08: 3 reports for this device; peer average 3.67/device2022-09: 0 reports for this device; peer average 3.8/device2022-10: 0 reports for this device; peer average 2.67/device2022-11: 0 reports for this device; peer average 3.2/device2022-12: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 4/device2023-02: 0 reports for this device; peer average 2.6/device2023-03: 0 reports for this device; peer average 2.6/device2023-04: 0 reports for this device; peer average 4/device2023-05: 0 reports for this device; peer average 2.29/device2023-06: 3 reports for this device; peer average 2.75/device2023-07: 3 reports for this device; peer average 2.29/device2023-08: 0 reports for this device; peer average 2.6/device2023-09: 0 reports for this device; peer average 2.29/device2023-10: 0 reports for this device; peer average 4.25/device2023-11: 0 reports for this device; peer average 4.4/device2023-12: 0 reports for this device; peer average 2.25/device2024-01: 0 reports for this device; peer average 1.33/device2024-02: 2 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 2.75/device2024-04: 2 reports for this device; peer average 3.5/device2024-05: 5 reports for this device; peer average 3.42/device2024-06: 0 reports for this device; peer average 3.4/device2024-07: 0 reports for this device; peer average 2.5/device2024-08: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 2.75/device2024-10: 2 reports for this device; peer average 1.67/device2024-11: 0 reports for this device; peer average 4.27/device2024-12: 0 reports for this device; peer average 2.33/device2025-01: 0 reports for this device; peer average 2.08/device2025-02: 0 reports for this device; peer average 2.5/device2025-03: 0 reports for this device; peer average 2.22/device2025-04: 0 reports for this device; peer average 3.25/device2025-05: 3 reports for this device; peer average 3.13/device2025-06: 0 reports for this device; peer average 3.56/device2025-07: 0 reports for this device; peer average 4.21/device2025-08: 0 reports for this device; peer average 3.5/device2025-09: 0 reports for this device; peer average 3.54/device2025-10: 0 reports for this device; peer average 2.84/device2025-11: 0 reports for this device; peer average 2.89/device2025-12: 6 reports for this device; peer average 2.18/device2026-01: 0 reports for this device; peer average 3.68/device2026-02: 0 reports for this device; peer average 4/device2026-03: 3 reports for this device; peer average 2.53/device2026-04: 0 reports for this device; peer average 2.88/device2026-05: 0 reports for this device; peer average 2.84/device2026-06: 0 reports for this device; peer average 5.37/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0201
2019-0302.75
2019-0403
2019-0502.67
2019-0602
2019-0702.88
2019-0802.25
2019-0922.83
2019-1002
2019-1102.67
2019-1203
2020-0103.25
2020-0203.5
2020-0302.67
2020-0402.25
2020-0532
2020-0602.2
2020-0704.5
2020-0803
2020-0903.25
2020-1003
2020-1132.44
2020-1203
2021-0103
2021-0265
2021-0304.33
2021-0403.14
2021-0502.6
2021-0603.6
2021-0704
2021-0832.6
2021-0902.5
2021-1034
2021-1103
2021-1232.2
2022-0103
2022-0202.82
2022-0306
2022-0403
2022-0533.5
2022-0632.78
2022-0733.17
2022-0833.67
2022-0903.8
2022-1002.67
2022-1103.2
2022-1203
2023-0104
2023-0202.6
2023-0302.6
2023-0404
2023-0502.29
2023-0632.75
2023-0732.29
2023-0802.6
2023-0902.29
2023-1004.25
2023-1104.4
2023-1202.25
2024-0101.33
2024-0223
2024-0302.75
2024-0423.5
2024-0553.42
2024-0603.4
2024-0702.5
2024-0803
2024-0902.75
2024-1021.67
2024-1104.27
2024-1202.33
2025-0102.08
2025-0202.5
2025-0302.22
2025-0403.25
2025-0533.13
2025-0603.56
2025-0704.21
2025-0803.5
2025-0903.54
2025-1002.84
2025-1102.89
2025-1262.18
2026-0103.68
2026-0204
2026-0332.53
2026-0402.88
2026-0502.84
2026-0605.37
This device (reports/month)Average device in NIM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ABBOTT VASCULAR INC.

  • NAI 2023-12-08 Abbott Vascular · 0 citations
  • OAI 2023-11-16 Abbott Vascular · 0 citations
  • NAI 2023-10-27 Abbott Vascular Inc · 0 citations
  • NAI 2022-08-23 Abbott Vascular Inc · 0 citations
  • NAI 2021-11-03 Abbott Vascular Inc · 0 citations
  • NAI 2019-10-24 Abbott Vascular · 0 citations
  • VAI 2017-11-15 Abbott Vascular · 2 citations
  • NAI 2017-10-10 Abbott Vascular · 0 citations
  • NAI 2017-10-04 Abbott Vascular Inc · 0 citations
  • NAI 2016-12-09 Abbott Vascular · 0 citations
  • NAI 2016-04-15 Abbott Vascular Inc · 0 citations
  • NAI 2015-12-10 Abbott Vascular · 0 citations
  • NAI 2015-09-11 Abbott Vascular · 0 citations
  • NAI 2015-08-14 Abbott Vascular, Inc. · 0 citations
  • NAI 2015-07-23 Abbott Vascular · 0 citations
  • NAI 2014-11-24 Abbott Vascular Inc · 0 citations
  • NAI 2014-08-21 Abbott Vascular · 0 citations
  • NAI 2014-03-14 Abbott Vascular · 0 citations
  • NAI 2014-02-19 Abbott Vascular · 0 citations
  • VAI 2014-02-11 Abbott Vascular Inc · 3 citations