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AVANTI

Model 402607P · Cordis US Corp. · DI 10705032000642

DRE — Dilator, Vessel, For Percutaneous Catheterization · Class II · 21 CFR 870.1310

UDILibrary device dossier · generated 2026-09-07 · 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

13452019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.4/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.78/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 1.5/device2019-08: 0 reports for this device; peer average 1.45/device2019-09: 0 reports for this device; peer average 3/device2019-10: 0 reports for this device; peer average 1.33/device2019-11: 0 reports for this device; peer average 3.88/device2019-12: 0 reports for this device; peer average 1.33/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.86/device2020-03: 0 reports for this device; peer average 1.5/device2020-04: 0 reports for this device; peer average 1.75/device2020-05: 0 reports for this device; peer average 1.83/device2020-06: 0 reports for this device; peer average 4.75/device2020-07: 0 reports for this device; peer average 2.25/device2020-08: 0 reports for this device; peer average 1.33/device2020-09: 0 reports for this device; peer average 1.8/device2020-10: 0 reports for this device; peer average 1.6/device2020-11: 0 reports for this device; peer average 1.3/device2020-12: 0 reports for this device; peer average 1.8/device2021-01: 0 reports for this device; peer average 1.75/device2021-02: 0 reports for this device; peer average 1.5/device2021-03: 0 reports for this device; peer average 1.5/device2021-04: 0 reports for this device; peer average 2.17/device2021-05: 0 reports for this device; peer average 1.5/device2021-06: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 2.6/device2021-08: 0 reports for this device; peer average 3.33/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1.4/device2021-12: 0 reports for this device; peer average 1.86/device2022-01: 0 reports for this device; peer average 1.14/device2022-02: 0 reports for this device; peer average 1.45/device2022-03: 0 reports for this device; peer average 2.69/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 2.45/device2022-06: 0 reports for this device; peer average 1.67/device2022-07: 0 reports for this device; peer average 1.67/device2022-08: 0 reports for this device; peer average 1.67/device2022-09: 0 reports for this device; peer average 1.91/device2022-10: 0 reports for this device; peer average 1.4/device2022-11: 0 reports for this device; peer average 1.5/device2022-12: 0 reports for this device; peer average 1.78/device2023-01: 0 reports for this device; peer average 1.4/device2023-02: 0 reports for this device; peer average 1.67/device2023-03: 0 reports for this device; peer average 2.62/device2023-04: 0 reports for this device; peer average 1.91/device2023-05: 0 reports for this device; peer average 2.3/device2023-06: 0 reports for this device; peer average 2.55/device2023-07: 0 reports for this device; peer average 3.8/device2023-08: 0 reports for this device; peer average 2.95/device2023-09: 0 reports for this device; peer average 4.67/device2023-10: 0 reports for this device; peer average 2.17/device2023-11: 0 reports for this device; peer average 3.36/device2023-12: 0 reports for this device; peer average 3.32/device2024-01: 0 reports for this device; peer average 2.31/device2024-02: 0 reports for this device; peer average 3.25/device2024-03: 0 reports for this device; peer average 2.45/device2024-04: 0 reports for this device; peer average 2.29/device2024-05: 0 reports for this device; peer average 3.27/device2024-06: 0 reports for this device; peer average 3.14/device2024-07: 0 reports for this device; peer average 1.81/device2024-08: 0 reports for this device; peer average 2.18/device2024-09: 0 reports for this device; peer average 2.57/device2024-10: 0 reports for this device; peer average 2.26/device2024-11: 0 reports for this device; peer average 2.25/device2024-12: 1 reports for this device; peer average 1.86/device2025-01: 0 reports for this device; peer average 2.15/device2025-02: 0 reports for this device; peer average 3.63/device2025-03: 0 reports for this device; peer average 2.71/device2025-04: 0 reports for this device; peer average 1.84/device2025-05: 0 reports for this device; peer average 2.05/device2025-06: 0 reports for this device; peer average 2.7/device2025-07: 0 reports for this device; peer average 3.32/device2025-08: 0 reports for this device; peer average 2.62/device2025-09: 0 reports for this device; peer average 1.85/device2025-10: 0 reports for this device; peer average 3.06/device2025-11: 0 reports for this device; peer average 1.86/device2025-12: 0 reports for this device; peer average 2.14/device2026-01: 0 reports for this device; peer average 2.2/device2026-02: 0 reports for this device; peer average 2.24/device2026-03: 0 reports for this device; peer average 3.11/device2026-04: 0 reports for this device; peer average 2.44/device2026-05: 0 reports for this device; peer average 5.14/device2026-06: 0 reports for this device; peer average 2.31/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0302.4
2019-0402
2019-0501.78
2019-0601.5
2019-0701.5
2019-0801.45
2019-0903
2019-1001.33
2019-1103.88
2019-1201.33
2020-0101.67
2020-0201.86
2020-0301.5
2020-0401.75
2020-0501.83
2020-0604.75
2020-0702.25
2020-0801.33
2020-0901.8
2020-1001.6
2020-1101.3
2020-1201.8
2021-0101.75
2021-0201.5
2021-0301.5
2021-0402.17
2021-0501.5
2021-0603
2021-0702.6
2021-0803.33
2021-0903
2021-1001
2021-1101.4
2021-1201.86
2022-0101.14
2022-0201.45
2022-0302.69
2022-0401
2022-0502.45
2022-0601.67
2022-0701.67
2022-0801.67
2022-0901.91
2022-1001.4
2022-1101.5
2022-1201.78
2023-0101.4
2023-0201.67
2023-0302.62
2023-0401.91
2023-0502.3
2023-0602.55
2023-0703.8
2023-0802.95
2023-0904.67
2023-1002.17
2023-1103.36
2023-1203.32
2024-0102.31
2024-0203.25
2024-0302.45
2024-0402.29
2024-0503.27
2024-0603.14
2024-0701.81
2024-0802.18
2024-0902.57
2024-1002.26
2024-1102.25
2024-1211.86
2025-0102.15
2025-0203.63
2025-0302.71
2025-0401.84
2025-0502.05
2025-0602.7
2025-0703.32
2025-0802.62
2025-0901.85
2025-1003.06
2025-1101.86
2025-1202.14
2026-0102.2
2026-0202.24
2026-0303.11
2026-0402.44
2026-0505.14
2026-0602.31
This device (reports/month)Average device in DRE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Cordis US Corp.

  • Warning Letter 2011-02-16 Cordis LLC
  • VAI 2022-06-29 Cordis US Corp · 0 citations
  • VAI 2022-06-29 Cordis US Corp · 0 citations
  • VAI 2018-01-12 Cordis US Corp · 1 citations
  • VAI 2018-01-12 Cordis US Corp · 1 citations
  • VAI 2017-09-15 AccessClosure, Inc., A Cardinal Health Company · 1 citations
  • NAI 2016-07-06 Cordis US Corp · 0 citations
  • NAI 2016-07-06 Cordis US Corp · 0 citations
  • NAI 2016-03-31 Cordis US Corp · 0 citations
  • NAI 2016-03-31 Cordis US Corp · 0 citations
  • VAI 2016-02-12 Cardinal Health Mexico 244 S de RL de CV · 3 citations
  • NAI 2016-02-01 AccessClosure, Inc., A Cardinal Health Company · 0 citations
  • NAI 2015-05-08 Cordis US Corp · 0 citations
  • NAI 2015-05-08 Cordis US Corp · 0 citations
  • VAI 2014-08-05 AccessClosure, Inc., A Cardinal Health Company · 3 citations
  • NAI 2014-04-03 Cardinal Health Mexico 244 S de RL de CV · 0 citations
  • NAI 2014-01-30 Cordis US Corp · 0 citations
  • NAI 2014-01-30 Cordis US Corp · 0 citations
  • NAI 2013-12-18 Cordis US Corp · 0 citations
  • NAI 2013-12-18 Cordis US Corp · 0 citations
  • NAI 2012-07-03 Cordis US Corp · 0 citations