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2D Helical - 35

Model M0013729060 · BOSTON SCIENTIFIC CORPORATION · DI 08714729237266

KRD — Device, Vascular, For Promoting Embolization · Class II · 21 CFR 870.3300

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 (1)

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: 1

12342019-01: 0 reports for this device; peer average 1.37/device2019-02: 0 reports for this device; peer average 1.37/device2019-03: 0 reports for this device; peer average 1.48/device2019-04: 0 reports for this device; peer average 1.49/device2019-05: 0 reports for this device; peer average 1.17/device2019-06: 0 reports for this device; peer average 1.12/device2019-07: 0 reports for this device; peer average 1.11/device2019-08: 0 reports for this device; peer average 1.13/device2019-09: 0 reports for this device; peer average 1.61/device2019-10: 0 reports for this device; peer average 1.62/device2019-11: 0 reports for this device; peer average 2.63/device2019-12: 0 reports for this device; peer average 1.2/device2020-01: 0 reports for this device; peer average 1.19/device2020-02: 1 reports for this device; peer average 1.77/device2020-03: 0 reports for this device; peer average 1.66/device2020-04: 0 reports for this device; peer average 2.65/device2020-05: 0 reports for this device; peer average 1.44/device2020-06: 0 reports for this device; peer average 1.2/device2020-07: 0 reports for this device; peer average 1.89/device2020-08: 0 reports for this device; peer average 1.9/device2020-09: 0 reports for this device; peer average 4.48/device2020-10: 0 reports for this device; peer average 2.06/device2020-11: 0 reports for this device; peer average 1.27/device2020-12: 0 reports for this device; peer average 1.97/device2021-01: 0 reports for this device; peer average 1.27/device2021-02: 0 reports for this device; peer average 1.19/device2021-03: 0 reports for this device; peer average 1.33/device2021-04: 0 reports for this device; peer average 1.88/device2021-05: 0 reports for this device; peer average 1.77/device2021-06: 0 reports for this device; peer average 1.3/device2021-07: 0 reports for this device; peer average 1.91/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.26/device2021-10: 0 reports for this device; peer average 1.87/device2021-11: 0 reports for this device; peer average 1.9/device2021-12: 0 reports for this device; peer average 3.67/device2022-01: 0 reports for this device; peer average 3.14/device2022-02: 0 reports for this device; peer average 1.43/device2022-03: 0 reports for this device; peer average 1.81/device2022-04: 0 reports for this device; peer average 1.38/device2022-05: 0 reports for this device; peer average 1.13/device2022-06: 0 reports for this device; peer average 1.11/device2022-07: 0 reports for this device; peer average 1.36/device2022-08: 0 reports for this device; peer average 1.82/device2022-09: 0 reports for this device; peer average 1.1/device2022-10: 0 reports for this device; peer average 3.21/device2022-11: 0 reports for this device; peer average 1.13/device2022-12: 0 reports for this device; peer average 1.13/device2023-01: 0 reports for this device; peer average 1.14/device2023-02: 0 reports for this device; peer average 1.13/device2023-03: 0 reports for this device; peer average 1.85/device2023-04: 0 reports for this device; peer average 2.6/device2023-05: 0 reports for this device; peer average 1.12/device2023-06: 0 reports for this device; peer average 1.81/device2023-07: 0 reports for this device; peer average 1.89/device2023-08: 0 reports for this device; peer average 1.51/device2023-09: 0 reports for this device; peer average 1.4/device2023-10: 0 reports for this device; peer average 1.45/device2023-11: 0 reports for this device; peer average 1.53/device2023-12: 0 reports for this device; peer average 1.29/device2024-01: 0 reports for this device; peer average 1.55/device2024-02: 0 reports for this device; peer average 1.3/device2024-03: 0 reports for this device; peer average 1.43/device2024-04: 0 reports for this device; peer average 1.38/device2024-05: 0 reports for this device; peer average 1.37/device2024-06: 0 reports for this device; peer average 1.4/device2024-07: 0 reports for this device; peer average 1.42/device2024-08: 0 reports for this device; peer average 1.34/device2024-09: 0 reports for this device; peer average 1.54/device2024-10: 0 reports for this device; peer average 1.54/device2024-11: 0 reports for this device; peer average 1.65/device2024-12: 0 reports for this device; peer average 1.75/device2025-01: 0 reports for this device; peer average 1.56/device2025-02: 0 reports for this device; peer average 1.86/device2025-03: 0 reports for this device; peer average 1.71/device2025-04: 0 reports for this device; peer average 1.71/device2025-05: 0 reports for this device; peer average 1.65/device2025-06: 0 reports for this device; peer average 1.94/device2025-07: 0 reports for this device; peer average 1.84/device2025-08: 0 reports for this device; peer average 1.74/device2025-09: 0 reports for this device; peer average 1.63/device2025-10: 0 reports for this device; peer average 1.85/device2025-11: 0 reports for this device; peer average 1.54/device2025-12: 0 reports for this device; peer average 2.05/device2026-01: 0 reports for this device; peer average 1.72/device2026-02: 0 reports for this device; peer average 1.81/device2026-03: 0 reports for this device; peer average 1.73/device2026-04: 0 reports for this device; peer average 2.01/device2026-05: 0 reports for this device; peer average 1.89/device2026-06: 0 reports for this device; peer average 1.84/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.37
2019-0201.37
2019-0301.48
2019-0401.49
2019-0501.17
2019-0601.12
2019-0701.11
2019-0801.13
2019-0901.61
2019-1001.62
2019-1102.63
2019-1201.2
2020-0101.19
2020-0211.77
2020-0301.66
2020-0402.65
2020-0501.44
2020-0601.2
2020-0701.89
2020-0801.9
2020-0904.48
2020-1002.06
2020-1101.27
2020-1201.97
2021-0101.27
2021-0201.19
2021-0301.33
2021-0401.88
2021-0501.77
2021-0601.3
2021-0701.91
2021-0802
2021-0901.26
2021-1001.87
2021-1101.9
2021-1203.67
2022-0103.14
2022-0201.43
2022-0301.81
2022-0401.38
2022-0501.13
2022-0601.11
2022-0701.36
2022-0801.82
2022-0901.1
2022-1003.21
2022-1101.13
2022-1201.13
2023-0101.14
2023-0201.13
2023-0301.85
2023-0402.6
2023-0501.12
2023-0601.81
2023-0701.89
2023-0801.51
2023-0901.4
2023-1001.45
2023-1101.53
2023-1201.29
2024-0101.55
2024-0201.3
2024-0301.43
2024-0401.38
2024-0501.37
2024-0601.4
2024-0701.42
2024-0801.34
2024-0901.54
2024-1001.54
2024-1101.65
2024-1201.75
2025-0101.56
2025-0201.86
2025-0301.71
2025-0401.71
2025-0501.65
2025-0601.94
2025-0701.84
2025-0801.74
2025-0901.63
2025-1001.85
2025-1101.54
2025-1202.05
2026-0101.72
2026-0201.81
2026-0301.73
2026-0402.01
2026-0501.89
2026-0601.84
This device (reports/month)Average device in KRD (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