Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Genesys HTA ProCerva

Model M006580210 · BOSTON SCIENTIFIC CORPORATION · DI 08714729809456

MNB — Device, Thermal Ablation, Endometrial · Class III

UDILibrary device dossier · generated 2026-09-15 · 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 (124)

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.

Injury: 70 · Malfunction: 54

4811152019-01: 6 reports for this device; peer average 2.29/device2019-02: 9 reports for this device; peer average 3/device2019-03: 12 reports for this device; peer average 4.43/device2019-04: 6 reports for this device; peer average 3.67/device2019-05: 14 reports for this device; peer average 5.83/device2019-06: 0 reports for this device; peer average 1.75/device2019-07: 10 reports for this device; peer average 4.17/device2019-08: 0 reports for this device; peer average 5/device2019-09: 5 reports for this device; peer average 2.57/device2019-10: 4 reports for this device; peer average 4.22/device2019-11: 12 reports for this device; peer average 4.25/device2019-12: 3 reports for this device; peer average 2.5/device2020-01: 3 reports for this device; peer average 2.78/device2020-02: 1 reports for this device; peer average 3.2/device2020-03: 0 reports for this device; peer average 2.43/device2020-04: 0 reports for this device; peer average 2.17/device2020-05: 0 reports for this device; peer average 3.33/device2020-06: 0 reports for this device; peer average 2.5/device2020-07: 0 reports for this device; peer average 2.71/device2020-08: 0 reports for this device; peer average 3.5/device2020-09: 15 reports for this device; peer average 4.86/device2020-10: 2 reports for this device; peer average 2.83/device2020-11: 8 reports for this device; peer average 3.6/device2020-12: 0 reports for this device; peer average 8/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 4/device2021-03: 0 reports for this device; peer average 8.2/device2021-04: 2 reports for this device; peer average 6.5/device2021-05: 0 reports for this device; peer average 7.8/device2021-06: 1 reports for this device; peer average 8/device2021-07: 0 reports for this device; peer average 4.83/device2021-08: 0 reports for this device; peer average 8.67/device2021-09: 2 reports for this device; peer average 3.71/device2021-10: 1 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 13/device2021-12: 0 reports for this device; peer average 13.75/device2022-01: 0 reports for this device; peer average 4.33/device2022-02: 1 reports for this device; peer average 2.17/device2022-03: 0 reports for this device; peer average 5.83/device2022-04: 0 reports for this device; peer average 2.25/device2022-05: 1 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 3.43/device2022-07: 0 reports for this device; peer average 5.5/device2022-08: 0 reports for this device; peer average 7.75/device2022-09: 0 reports for this device; peer average 3.4/device2022-10: 0 reports for this device; peer average 5.43/device2022-11: 0 reports for this device; peer average 4.63/device2022-12: 0 reports for this device; peer average 11.2/device2023-01: 0 reports for this device; peer average 5.83/device2023-02: 2 reports for this device; peer average 3.71/device2023-03: 2 reports for this device; peer average 5.57/device2023-04: 0 reports for this device; peer average 7.2/device2023-05: 1 reports for this device; peer average 5.6/device2023-06: 0 reports for this device; peer average 6.17/device2023-07: 0 reports for this device; peer average 5.75/device2023-08: 0 reports for this device; peer average 6/device2023-09: 0 reports for this device; peer average 3.22/device2023-10: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 5.44/device2023-12: 0 reports for this device; peer average 7/device2024-01: 0 reports for this device; peer average 4.22/device2024-02: 0 reports for this device; peer average 12.75/device2024-03: 0 reports for this device; peer average 6.17/device2024-04: 0 reports for this device; peer average 3.8/device2024-05: 0 reports for this device; peer average 10.5/device2024-06: 0 reports for this device; peer average 3.71/device2024-07: 0 reports for this device; peer average 2.75/device2024-08: 0 reports for this device; peer average 2.33/device2024-09: 0 reports for this device; peer average 5.67/device2024-10: 0 reports for this device; peer average 3.8/device2024-11: 1 reports for this device; peer average 5.5/device2024-12: 0 reports for this device; peer average 3/device2025-01: 0 reports for this device; peer average 4.56/device2025-02: 0 reports for this device; peer average 4.67/device2025-03: 0 reports for this device; peer average 6.33/device2025-04: 0 reports for this device; peer average 5.14/device2025-05: 0 reports for this device; peer average 7.25/device2025-06: 0 reports for this device; peer average 6.14/device2025-07: 0 reports for this device; peer average 3/device2025-08: 0 reports for this device; peer average 9/device2025-09: 0 reports for this device; peer average 4.17/device2025-10: 0 reports for this device; peer average 4/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 5.33/device2026-01: 0 reports for this device; peer average 5.5/device2026-02: 0 reports for this device; peer average 4.4/device2026-03: 0 reports for this device; peer average 11/device2026-04: 0 reports for this device; peer average 4.5/device2026-05: 0 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 8.5/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0162.29
2019-0293
2019-03124.43
2019-0463.67
2019-05145.83
2019-0601.75
2019-07104.17
2019-0805
2019-0952.57
2019-1044.22
2019-11124.25
2019-1232.5
2020-0132.78
2020-0213.2
2020-0302.43
2020-0402.17
2020-0503.33
2020-0602.5
2020-0702.71
2020-0803.5
2020-09154.86
2020-1022.83
2020-1183.6
2020-1208
2021-0102.67
2021-0204
2021-0308.2
2021-0426.5
2021-0507.8
2021-0618
2021-0704.83
2021-0808.67
2021-0923.71
2021-1014
2021-11013
2021-12013.75
2022-0104.33
2022-0212.17
2022-0305.83
2022-0402.25
2022-0512.5
2022-0603.43
2022-0705.5
2022-0807.75
2022-0903.4
2022-1005.43
2022-1104.63
2022-12011.2
2023-0105.83
2023-0223.71
2023-0325.57
2023-0407.2
2023-0515.6
2023-0606.17
2023-0705.75
2023-0806
2023-0903.22
2023-1004
2023-1105.44
2023-1207
2024-0104.22
2024-02012.75
2024-0306.17
2024-0403.8
2024-05010.5
2024-0603.71
2024-0702.75
2024-0802.33
2024-0905.67
2024-1003.8
2024-1115.5
2024-1203
2025-0104.56
2025-0204.67
2025-0306.33
2025-0405.14
2025-0507.25
2025-0606.14
2025-0703
2025-0809
2025-0904.17
2025-1004
2025-1103
2025-1205.33
2026-0105.5
2026-0204.4
2026-03011
2026-0404.5
2026-0502.33
2026-0608.5
This device (reports/month)Average device in MNB (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