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SOLO FLEX Hybrid Guidewires

Model HW38FS · HERAEUS MEDICAL COMPONENTS LLC · DI 00816840020340

EZB — Stylet For Catheter, Gastro-Urology · Class I · 21 CFR 876.5130

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 (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.

24682019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1.33/device2019-08: 0 reports for this device; peer average 1.33/device2019-09: 0 reports for this device; peer average 1.4/device2019-10: 0 reports for this device; peer average 1.2/device2019-11: 0 reports for this device; peer average 1.33/device2019-12: 0 reports for this device; peer average 1.67/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 3.33/device2020-07: 0 reports for this device; peer average 1.8/device2020-08: 0 reports for this device; peer average 1.75/device2020-09: 0 reports for this device; peer average 1.75/device2020-10: 0 reports for this device; peer average 1.25/device2020-11: 0 reports for this device; peer average 1.2/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1.43/device2021-04: 0 reports for this device; peer average 1.33/device2021-05: 0 reports for this device; peer average 1.29/device2021-06: 0 reports for this device; peer average 2.33/device2021-07: 0 reports for this device; peer average 2.67/device2021-08: 0 reports for this device; peer average 1.2/device2021-09: 0 reports for this device; peer average 1.75/device2021-10: 0 reports for this device; peer average 2.33/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1.25/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 2.75/device2022-06: 0 reports for this device; peer average 4/device2022-07: 0 reports for this device; peer average 2.33/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1.6/device2022-10: 0 reports for this device; peer average 1.5/device2022-11: 0 reports for this device; peer average 7.5/device2022-12: 0 reports for this device; peer average 1.8/device2023-01: 0 reports for this device; peer average 4/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 5.5/device2023-05: 0 reports for this device; peer average 4.5/device2023-06: 0 reports for this device; peer average 1.75/device2023-07: 0 reports for this device; peer average 2.71/device2023-08: 0 reports for this device; peer average 2.56/device2023-09: 0 reports for this device; peer average 3.14/device2023-10: 0 reports for this device; peer average 2.75/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 2.33/device2024-01: 0 reports for this device; peer average 1.67/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2.5/device2024-05: 0 reports for this device; peer average 2.5/device2024-06: 0 reports for this device; peer average 1.33/device2024-07: 0 reports for this device; peer average 3.33/device2024-08: 0 reports for this device; peer average 2.86/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 0 reports for this device; peer average 3.2/device2024-11: 0 reports for this device; peer average 1.71/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 4.5/device2025-02: 0 reports for this device; peer average 2.5/device2025-03: 0 reports for this device; peer average 2.33/device2025-04: 0 reports for this device; peer average 3.33/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.75/device2025-07: 0 reports for this device; peer average 1.67/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 2.6/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 3.4/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.75/device2026-03: 0 reports for this device; peer average 2.5/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 3.67/device2026-06: 0 reports for this device; peer average 1.75/device03040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0301
2019-0402
2019-0501
2019-0601
2019-0701.33
2019-0801.33
2019-0901.4
2019-1001.2
2019-1101.33
2019-1201.67
2020-0101.67
2020-0201.5
2020-0301
2020-0401
2020-0501
2020-0603.33
2020-0701.8
2020-0801.75
2020-0901.75
2020-1001.25
2020-1101.2
2020-1201
2021-0101.5
2021-0201
2021-0301.43
2021-0401.33
2021-0501.29
2021-0602.33
2021-0702.67
2021-0801.2
2021-0901.75
2021-1002.33
2021-1101.5
2021-1202
2022-0102
2022-0202
2022-0301.25
2022-0401
2022-0502.75
2022-0604
2022-0702.33
2022-0802
2022-0901.6
2022-1001.5
2022-1107.5
2022-1201.8
2023-0104
2023-0201.5
2023-0303
2023-0405.5
2023-0504.5
2023-0601.75
2023-0702.71
2023-0802.56
2023-0903.14
2023-1002.75
2023-1101.5
2023-1202.33
2024-0101.67
2024-0201.5
2024-0302
2024-0402.5
2024-0502.5
2024-0601.33
2024-0703.33
2024-0802.86
2024-0901.67
2024-1003.2
2024-1101.71
2024-1201.67
2025-0104.5
2025-0202.5
2025-0302.33
2025-0403.33
2025-0502
2025-0601.75
2025-0701.67
2025-0802
2025-0902.6
2025-1004
2025-1103
2025-1203.4
2026-0102
2026-0201.75
2026-0302.5
2026-0402
2026-0503.67
2026-0601.75
This device (reports/month)Average device in EZB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — HERAEUS MEDICAL COMPONENTS LLC

  • NAI 2026-05-14 Heraeus Medical Components Caribe, Inc. · 0 citations
  • VAI 2023-08-03 Heraeus Medical Components, Srl · 5 citations
  • VAI 2023-08-03 Heraeus Medical Components, Srl · 5 citations
  • NAI 2023-02-14 Heraeus Medical Components Caribe, Inc. · 0 citations
  • NAI 2017-03-07 Heraeus Medical Components Caribe, Inc. · 0 citations
  • NAI 2016-10-05 Heraeus Medical Components LLC · 0 citations
  • VAI 2016-07-14 HERAEUS MEDICAL COMPONENTS, SRL · 4 citations
  • VAI 2013-07-02 Heraeus Medical Components LLC · 2 citations
  • NAI 2010-08-25 Heraeus Medical Components LLC · 0 citations