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CRE Pulmonary

Model M00550300 · BOSTON SCIENTIFIC CORPORATION · DI 08714729456186

KTI — Bronchoscope Accessory · Class II · 21 CFR 874.4680

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 (26)

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: 26

4711142019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1.67/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 2.5/device2019-07: 0 reports for this device; peer average 4/device2019-08: 0 reports for this device; peer average 14/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 2/device2019-11: 2 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 3.5/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 4/device2020-08: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 8/device2020-10: 2 reports for this device; peer average 2/device2020-12: 2 reports for this device; peer average 4/device2021-01: 0 reports for this device; peer average 6/device2021-02: 0 reports for this device; peer average 1.67/device2021-03: 0 reports for this device; peer average 2.5/device2021-04: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 2.5/device2021-07: 0 reports for this device; peer average 3/device2021-08: 2 reports for this device; peer average 2.25/device2021-09: 6 reports for this device; peer average 3.67/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 5/device2021-12: 2 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2.67/device2022-03: 0 reports for this device; peer average 11/device2022-04: 0 reports for this device; peer average 3.33/device2022-05: 0 reports for this device; peer average 6.67/device2022-06: 4 reports for this device; peer average 4.67/device2022-07: 0 reports for this device; peer average 10/device2022-08: 0 reports for this device; peer average 12.67/device2022-09: 0 reports for this device; peer average 9.5/device2022-10: 0 reports for this device; peer average 4.75/device2022-11: 0 reports for this device; peer average 3.5/device2022-12: 0 reports for this device; peer average 3.2/device2023-01: 0 reports for this device; peer average 11/device2023-02: 0 reports for this device; peer average 5/device2023-03: 0 reports for this device; peer average 7.33/device2023-04: 0 reports for this device; peer average 11.75/device2023-05: 0 reports for this device; peer average 9/device2023-06: 0 reports for this device; peer average 2.5/device2023-07: 0 reports for this device; peer average 3/device2023-08: 0 reports for this device; peer average 4/device2023-09: 2 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 5.67/device2023-11: 0 reports for this device; peer average 5.83/device2023-12: 0 reports for this device; peer average 5.8/device2024-01: 0 reports for this device; peer average 10/device2024-02: 0 reports for this device; peer average 3.75/device2024-03: 0 reports for this device; peer average 5.33/device2024-04: 0 reports for this device; peer average 4.4/device2024-05: 0 reports for this device; peer average 6.75/device2024-06: 0 reports for this device; peer average 8.5/device2024-07: 0 reports for this device; peer average 9.5/device2024-08: 0 reports for this device; peer average 5/device2024-09: 0 reports for this device; peer average 5/device2024-10: 0 reports for this device; peer average 3.8/device2024-11: 0 reports for this device; peer average 8/device2024-12: 2 reports for this device; peer average 3.5/device2025-01: 0 reports for this device; peer average 4.67/device2025-02: 0 reports for this device; peer average 4/device2025-03: 0 reports for this device; peer average 6.67/device2025-04: 0 reports for this device; peer average 9.5/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 8.75/device2025-07: 0 reports for this device; peer average 9.67/device2025-08: 0 reports for this device; peer average 5.6/device2025-09: 0 reports for this device; peer average 5/device2025-10: 0 reports for this device; peer average 7.17/device2025-11: 0 reports for this device; peer average 8.2/device2025-12: 0 reports for this device; peer average 9.17/device2026-01: 0 reports for this device; peer average 7.83/device2026-02: 0 reports for this device; peer average 8.5/device2026-03: 0 reports for this device; peer average 3.5/device2026-04: 2 reports for this device; peer average 4.14/device2026-05: 0 reports for this device; peer average 3.25/device2026-06: 0 reports for this device; peer average 4.5/device0103040506070809101112010203040607080910120102030405060708091011120103040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0301.67
2019-0401
2019-0502
2019-0602.5
2019-0704
2019-08014
2019-0902
2019-1002
2019-1122
2019-1201
2020-0103
2020-0201.5
2020-0302
2020-0403.5
2020-0602
2020-0704
2020-0803
2020-0908
2020-1022
2020-1224
2021-0106
2021-0201.67
2021-0302.5
2021-0403
2021-0503
2021-0602.5
2021-0703
2021-0822.25
2021-0963.67
2021-1001
2021-1105
2021-1222
2022-0102.67
2022-03011
2022-0403.33
2022-0506.67
2022-0644.67
2022-07010
2022-08012.67
2022-0909.5
2022-1004.75
2022-1103.5
2022-1203.2
2023-01011
2023-0205
2023-0307.33
2023-04011.75
2023-0509
2023-0602.5
2023-0703
2023-0804
2023-0922
2023-1005.67
2023-1105.83
2023-1205.8
2024-01010
2024-0203.75
2024-0305.33
2024-0404.4
2024-0506.75
2024-0608.5
2024-0709.5
2024-0805
2024-0905
2024-1003.8
2024-1108
2024-1223.5
2025-0104.67
2025-0204
2025-0306.67
2025-0409.5
2025-0503
2025-0608.75
2025-0709.67
2025-0805.6
2025-0905
2025-1007.17
2025-1108.2
2025-1209.17
2026-0107.83
2026-0208.5
2026-0303.5
2026-0424.14
2026-0503.25
2026-0604.5
This device (reports/month)Average device in KTI (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
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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