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CRE Wireguided

Model M00558390 · BOSTON SCIENTIFIC CORPORATION · DI 08714729339328

FDF — Colonoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500

FDT — Duodenoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500

KNQ — Dilator, Esophageal · Class II · 21 CFR 876.5365

UDILibrary device dossier · generated 2026-09-14 · 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 (37)

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: 37

122435472019-01: 0 reports for this device; peer average 3.87/device2019-02: 0 reports for this device; peer average 2.72/device2019-03: 2 reports for this device; peer average 2.96/device2019-04: 0 reports for this device; peer average 2.34/device2019-05: 0 reports for this device; peer average 3.5/device2019-06: 2 reports for this device; peer average 3.07/device2019-07: 2 reports for this device; peer average 4.67/device2019-08: 4 reports for this device; peer average 2.58/device2019-09: 0 reports for this device; peer average 2.32/device2019-10: 0 reports for this device; peer average 2.89/device2019-11: 0 reports for this device; peer average 3.66/device2019-12: 2 reports for this device; peer average 3.36/device2020-01: 0 reports for this device; peer average 2.58/device2020-02: 0 reports for this device; peer average 3.61/device2020-03: 0 reports for this device; peer average 3.57/device2020-04: 0 reports for this device; peer average 2.66/device2020-05: 0 reports for this device; peer average 4.78/device2020-06: 2 reports for this device; peer average 3.05/device2020-07: 2 reports for this device; peer average 7.65/device2020-08: 2 reports for this device; peer average 4.6/device2020-09: 0 reports for this device; peer average 4.93/device2020-10: 2 reports for this device; peer average 5.16/device2020-11: 0 reports for this device; peer average 5.22/device2020-12: 0 reports for this device; peer average 6.96/device2021-01: 0 reports for this device; peer average 7.7/device2021-02: 0 reports for this device; peer average 8.54/device2021-03: 0 reports for this device; peer average 11.25/device2021-04: 0 reports for this device; peer average 8.47/device2021-05: 0 reports for this device; peer average 7.84/device2021-06: 0 reports for this device; peer average 7.66/device2021-07: 0 reports for this device; peer average 6.83/device2021-08: 2 reports for this device; peer average 6.6/device2021-09: 0 reports for this device; peer average 10.21/device2021-10: 0 reports for this device; peer average 7.58/device2021-11: 0 reports for this device; peer average 9.04/device2021-12: 0 reports for this device; peer average 11.07/device2022-01: 0 reports for this device; peer average 7.83/device2022-02: 0 reports for this device; peer average 12.36/device2022-03: 0 reports for this device; peer average 10.63/device2022-04: 0 reports for this device; peer average 11.37/device2022-05: 0 reports for this device; peer average 11.04/device2022-06: 0 reports for this device; peer average 12.57/device2022-07: 2 reports for this device; peer average 9.38/device2022-08: 0 reports for this device; peer average 9.12/device2022-09: 0 reports for this device; peer average 10.89/device2022-10: 0 reports for this device; peer average 11.28/device2022-11: 0 reports for this device; peer average 9.71/device2022-12: 0 reports for this device; peer average 10.9/device2023-01: 0 reports for this device; peer average 9.57/device2023-02: 0 reports for this device; peer average 9.61/device2023-03: 0 reports for this device; peer average 11.7/device2023-04: 0 reports for this device; peer average 12.12/device2023-05: 2 reports for this device; peer average 10.43/device2023-06: 2 reports for this device; peer average 10.88/device2023-07: 0 reports for this device; peer average 13.01/device2023-08: 0 reports for this device; peer average 11.75/device2023-09: 2 reports for this device; peer average 10.87/device2023-10: 0 reports for this device; peer average 13.42/device2023-11: 0 reports for this device; peer average 13.96/device2023-12: 2 reports for this device; peer average 12.2/device2024-01: 0 reports for this device; peer average 11.83/device2024-02: 0 reports for this device; peer average 12.29/device2024-03: 0 reports for this device; peer average 14.75/device2024-04: 0 reports for this device; peer average 11.63/device2024-05: 0 reports for this device; peer average 10.75/device2024-06: 0 reports for this device; peer average 11.37/device2024-07: 0 reports for this device; peer average 11.58/device2024-08: 0 reports for this device; peer average 9.35/device2024-09: 0 reports for this device; peer average 10.02/device2024-10: 0 reports for this device; peer average 12.57/device2024-11: 0 reports for this device; peer average 7.01/device2024-12: 1 reports for this device; peer average 4.92/device2025-01: 0 reports for this device; peer average 6.15/device2025-02: 0 reports for this device; peer average 5.52/device2025-03: 4 reports for this device; peer average 6.71/device2025-04: 0 reports for this device; peer average 7.18/device2025-05: 0 reports for this device; peer average 8.77/device2025-06: 0 reports for this device; peer average 8.46/device2025-07: 0 reports for this device; peer average 8.25/device2025-08: 0 reports for this device; peer average 9.83/device2025-09: 0 reports for this device; peer average 6.72/device2025-10: 0 reports for this device; peer average 13.32/device2025-11: 0 reports for this device; peer average 22.15/device2025-12: 0 reports for this device; peer average 47.11/device2026-01: 0 reports for this device; peer average 36.87/device2026-02: 0 reports for this device; peer average 22.32/device2026-03: 0 reports for this device; peer average 21.97/device2026-04: 0 reports for this device; peer average 28.1/device2026-05: 0 reports for this device; peer average 32.9/device2026-06: 0 reports for this device; peer average 33.73/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.87
2019-0202.72
2019-0322.96
2019-0402.34
2019-0503.5
2019-0623.07
2019-0724.67
2019-0842.58
2019-0902.32
2019-1002.89
2019-1103.66
2019-1223.36
2020-0102.58
2020-0203.61
2020-0303.57
2020-0402.66
2020-0504.78
2020-0623.05
2020-0727.65
2020-0824.6
2020-0904.93
2020-1025.16
2020-1105.22
2020-1206.96
2021-0107.7
2021-0208.54
2021-03011.25
2021-0408.47
2021-0507.84
2021-0607.66
2021-0706.83
2021-0826.6
2021-09010.21
2021-1007.58
2021-1109.04
2021-12011.07
2022-0107.83
2022-02012.36
2022-03010.63
2022-04011.37
2022-05011.04
2022-06012.57
2022-0729.38
2022-0809.12
2022-09010.89
2022-10011.28
2022-1109.71
2022-12010.9
2023-0109.57
2023-0209.61
2023-03011.7
2023-04012.12
2023-05210.43
2023-06210.88
2023-07013.01
2023-08011.75
2023-09210.87
2023-10013.42
2023-11013.96
2023-12212.2
2024-01011.83
2024-02012.29
2024-03014.75
2024-04011.63
2024-05010.75
2024-06011.37
2024-07011.58
2024-0809.35
2024-09010.02
2024-10012.57
2024-1107.01
2024-1214.92
2025-0106.15
2025-0205.52
2025-0346.71
2025-0407.18
2025-0508.77
2025-0608.46
2025-0708.25
2025-0809.83
2025-0906.72
2025-10013.32
2025-11022.15
2025-12047.11
2026-01036.87
2026-02022.32
2026-03021.97
2026-04028.1
2026-05032.9
2026-06033.73
This device (reports/month)Average device in FDF, FDT, KNQ (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
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  • VAI 2024-11-26 Boston Scientific Corporation · 3 citations
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  • 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