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AVVIGO™ Guidance System

Model H749009761Z0 · BOSTON SCIENTIFIC CORPORATION · DI 08714729996552

DQK — Computer, Diagnostic, Programmable · Class II · 21 CFR 870.1425

DSK — Computer, Blood-Pressure · Class II · 21 CFR 870.1110

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.

23572019-01: 0 reports for this device; peer average 2.91/device2019-02: 0 reports for this device; peer average 1.64/device2019-03: 0 reports for this device; peer average 3.11/device2019-04: 0 reports for this device; peer average 2.71/device2019-05: 0 reports for this device; peer average 1.63/device2019-06: 0 reports for this device; peer average 2.53/device2019-07: 0 reports for this device; peer average 2.14/device2019-08: 0 reports for this device; peer average 2.19/device2019-09: 0 reports for this device; peer average 2.08/device2019-10: 0 reports for this device; peer average 2.89/device2019-11: 0 reports for this device; peer average 2.29/device2019-12: 0 reports for this device; peer average 2.47/device2020-01: 0 reports for this device; peer average 1.55/device2020-02: 0 reports for this device; peer average 2.19/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 2.75/device2020-05: 0 reports for this device; peer average 2.25/device2020-06: 0 reports for this device; peer average 2.38/device2020-07: 0 reports for this device; peer average 1.94/device2020-08: 0 reports for this device; peer average 2.86/device2020-09: 0 reports for this device; peer average 1.83/device2020-10: 0 reports for this device; peer average 2.29/device2020-11: 0 reports for this device; peer average 3.25/device2020-12: 0 reports for this device; peer average 2.42/device2021-01: 0 reports for this device; peer average 2.83/device2021-02: 0 reports for this device; peer average 2.41/device2021-03: 0 reports for this device; peer average 2.73/device2021-04: 0 reports for this device; peer average 3.06/device2021-05: 0 reports for this device; peer average 6.5/device2021-06: 0 reports for this device; peer average 2.69/device2021-07: 0 reports for this device; peer average 2.32/device2021-08: 0 reports for this device; peer average 4.73/device2021-09: 0 reports for this device; peer average 3.72/device2021-10: 0 reports for this device; peer average 2.41/device2021-11: 0 reports for this device; peer average 3.22/device2021-12: 0 reports for this device; peer average 3.86/device2022-01: 0 reports for this device; peer average 3.75/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 3.9/device2022-04: 0 reports for this device; peer average 3.23/device2022-05: 0 reports for this device; peer average 3.14/device2022-06: 0 reports for this device; peer average 2.84/device2022-07: 0 reports for this device; peer average 2.44/device2022-08: 0 reports for this device; peer average 2.35/device2022-09: 0 reports for this device; peer average 3.16/device2022-10: 0 reports for this device; peer average 2.93/device2022-11: 0 reports for this device; peer average 2.31/device2022-12: 0 reports for this device; peer average 3.36/device2023-01: 0 reports for this device; peer average 2.85/device2023-02: 0 reports for this device; peer average 3.76/device2023-03: 0 reports for this device; peer average 3.21/device2023-04: 0 reports for this device; peer average 2.77/device2023-05: 0 reports for this device; peer average 3.05/device2023-06: 0 reports for this device; peer average 3.64/device2023-07: 0 reports for this device; peer average 2.38/device2023-08: 0 reports for this device; peer average 2.07/device2023-09: 0 reports for this device; peer average 2.31/device2023-10: 0 reports for this device; peer average 2.23/device2023-11: 0 reports for this device; peer average 3.93/device2023-12: 0 reports for this device; peer average 6.88/device2024-01: 0 reports for this device; peer average 3.86/device2024-02: 0 reports for this device; peer average 4.57/device2024-03: 0 reports for this device; peer average 4.29/device2024-04: 0 reports for this device; peer average 5.05/device2024-05: 0 reports for this device; peer average 6.04/device2024-06: 0 reports for this device; peer average 6.22/device2024-07: 0 reports for this device; peer average 3.22/device2024-08: 0 reports for this device; peer average 4.25/device2024-09: 0 reports for this device; peer average 4.47/device2024-10: 0 reports for this device; peer average 3.1/device2024-11: 0 reports for this device; peer average 3.82/device2024-12: 0 reports for this device; peer average 3.38/device2025-01: 0 reports for this device; peer average 4/device2025-02: 0 reports for this device; peer average 3.35/device2025-03: 0 reports for this device; peer average 3.28/device2025-04: 0 reports for this device; peer average 2.95/device2025-05: 0 reports for this device; peer average 5.05/device2025-06: 0 reports for this device; peer average 1.83/device2025-07: 0 reports for this device; peer average 2.62/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 2.22/device2025-10: 0 reports for this device; peer average 2.12/device2025-11: 0 reports for this device; peer average 3.24/device2025-12: 0 reports for this device; peer average 2.68/device2026-01: 0 reports for this device; peer average 2.88/device2026-02: 0 reports for this device; peer average 3.53/device2026-03: 0 reports for this device; peer average 2.38/device2026-04: 0 reports for this device; peer average 2.46/device2026-05: 0 reports for this device; peer average 2.71/device2026-06: 0 reports for this device; peer average 2.34/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.91
2019-0201.64
2019-0303.11
2019-0402.71
2019-0501.63
2019-0602.53
2019-0702.14
2019-0802.19
2019-0902.08
2019-1002.89
2019-1102.29
2019-1202.47
2020-0101.55
2020-0202.19
2020-0303
2020-0402.75
2020-0502.25
2020-0602.38
2020-0701.94
2020-0802.86
2020-0901.83
2020-1002.29
2020-1103.25
2020-1202.42
2021-0102.83
2021-0202.41
2021-0302.73
2021-0403.06
2021-0506.5
2021-0602.69
2021-0702.32
2021-0804.73
2021-0903.72
2021-1002.41
2021-1103.22
2021-1203.86
2022-0103.75
2022-0203
2022-0303.9
2022-0403.23
2022-0503.14
2022-0602.84
2022-0702.44
2022-0802.35
2022-0903.16
2022-1002.93
2022-1102.31
2022-1203.36
2023-0102.85
2023-0203.76
2023-0303.21
2023-0402.77
2023-0503.05
2023-0603.64
2023-0702.38
2023-0802.07
2023-0902.31
2023-1002.23
2023-1103.93
2023-1206.88
2024-0103.86
2024-0204.57
2024-0304.29
2024-0405.05
2024-0506.04
2024-0606.22
2024-0703.22
2024-0804.25
2024-0904.47
2024-1003.1
2024-1103.82
2024-1203.38
2025-0104
2025-0203.35
2025-0303.28
2025-0402.95
2025-0505.05
2025-0601.83
2025-0702.62
2025-0802.5
2025-0902.22
2025-1002.12
2025-1103.24
2025-1202.68
2026-0102.88
2026-0203.53
2026-0302.38
2026-0402.46
2026-0502.71
2026-0602.34
This device (reports/month)Average device in DQK, DSK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BOSTON SCIENTIFIC CORPORATION

  • Warning Letter 2014-04-10 Boston Scientific Corporation
  • OAI 2025-04-07 Boston Scientific Corporation · 9 citations
  • OAI 2025-04-07 Boston Scientific Corporation · 9 citations
  • NAI 2025-03-18 Boston Scientific Corporation · 0 citations
  • NAI 2025-03-18 Boston Scientific Corporation · 0 citations
  • NAI 2024-12-06 Nalu Medical, Inc. · 0 citations
  • VAI 2024-11-26 Boston Scientific Corporation · 3 citations
  • VAI 2024-11-26 Boston Scientific Corporation · 3 citations
  • NAI 2024-06-13 Elutia Inc · 0 citations
  • VAI 2024-01-23 Silk Road Medical · 1 citations
  • NAI 2023-12-05 Valencia Technologies Corporation · 0 citations
  • VAI 2023-12-01 Corbin Clinical Resources, Llc · 1 citations
  • NAI 2023-08-01 Boston Scientific Corporation · 0 citations
  • NAI 2023-08-01 Boston Scientific Corporation · 0 citations
  • NAI 2023-04-05 Intera Oncology, Inc. · 0 citations
  • NAI 2022-07-28 Boston Scientific Corporation · 0 citations
  • NAI 2022-07-28 Boston Scientific Corporation · 0 citations
  • VAI 2022-06-02 Boston Scientific de Costa Rica SRL · 0 citations
  • NAI 2022-03-23 Axonics, Inc. · 0 citations
  • VAI 2021-11-17 Valencia Technologies Corporation · 1 citations
  • NAI 2021-10-29 Boston Scientific Corporation · 0 citations