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ADMIRAL XTREME

Model ADM070200130 · MEDTRONIC, INC. · DI 08033477057408

DQY — Catheter, Percutaneous · Class II · 21 CFR 870.1250

LIT — Catheter, Angioplasty, Peripheral, Transluminal · Class II · 21 CFR 870.1250

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 (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.

12342019-01: 0 reports for this device; peer average 2.43/device2019-02: 0 reports for this device; peer average 1.88/device2019-03: 0 reports for this device; peer average 1.74/device2019-04: 0 reports for this device; peer average 2.26/device2019-05: 0 reports for this device; peer average 1.81/device2019-06: 0 reports for this device; peer average 1.93/device2019-07: 0 reports for this device; peer average 2.53/device2019-08: 0 reports for this device; peer average 2.09/device2019-09: 0 reports for this device; peer average 1.87/device2019-10: 0 reports for this device; peer average 2.74/device2019-11: 0 reports for this device; peer average 1.94/device2019-12: 0 reports for this device; peer average 2.04/device2020-01: 0 reports for this device; peer average 2.8/device2020-02: 0 reports for this device; peer average 2.14/device2020-03: 0 reports for this device; peer average 2.24/device2020-04: 0 reports for this device; peer average 2.75/device2020-05: 0 reports for this device; peer average 2.13/device2020-06: 0 reports for this device; peer average 2.32/device2020-07: 0 reports for this device; peer average 3.12/device2020-08: 0 reports for this device; peer average 2.29/device2020-09: 0 reports for this device; peer average 2.28/device2020-10: 0 reports for this device; peer average 3.12/device2020-11: 0 reports for this device; peer average 2.19/device2020-12: 0 reports for this device; peer average 2.55/device2021-01: 0 reports for this device; peer average 2.46/device2021-02: 0 reports for this device; peer average 2.6/device2021-03: 0 reports for this device; peer average 2.51/device2021-04: 0 reports for this device; peer average 2.41/device2021-05: 0 reports for this device; peer average 2.68/device2021-06: 0 reports for this device; peer average 2.53/device2021-07: 0 reports for this device; peer average 2.44/device2021-08: 0 reports for this device; peer average 2.48/device2021-09: 0 reports for this device; peer average 2.34/device2021-10: 0 reports for this device; peer average 2.46/device2021-11: 0 reports for this device; peer average 2.27/device2021-12: 0 reports for this device; peer average 2.34/device2022-01: 0 reports for this device; peer average 2.34/device2022-02: 0 reports for this device; peer average 2.36/device2022-03: 0 reports for this device; peer average 2.3/device2022-04: 0 reports for this device; peer average 2.3/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 2.3/device2022-07: 0 reports for this device; peer average 2.22/device2022-08: 0 reports for this device; peer average 2.42/device2022-09: 0 reports for this device; peer average 2.18/device2022-10: 0 reports for this device; peer average 2.29/device2022-11: 0 reports for this device; peer average 2.13/device2022-12: 0 reports for this device; peer average 2.18/device2023-01: 0 reports for this device; peer average 2.15/device2023-02: 0 reports for this device; peer average 2.12/device2023-03: 0 reports for this device; peer average 2.28/device2023-04: 0 reports for this device; peer average 2.26/device2023-05: 0 reports for this device; peer average 1.95/device2023-06: 0 reports for this device; peer average 2.25/device2023-07: 0 reports for this device; peer average 2.22/device2023-08: 0 reports for this device; peer average 1.86/device2023-09: 0 reports for this device; peer average 1.85/device2023-10: 0 reports for this device; peer average 2.14/device2023-11: 0 reports for this device; peer average 2.18/device2023-12: 0 reports for this device; peer average 2.12/device2024-01: 0 reports for this device; peer average 1.85/device2024-02: 0 reports for this device; peer average 1.92/device2024-03: 0 reports for this device; peer average 1.84/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.97/device2024-06: 0 reports for this device; peer average 2.05/device2024-07: 0 reports for this device; peer average 2.06/device2024-08: 0 reports for this device; peer average 1.97/device2024-09: 0 reports for this device; peer average 2.11/device2024-10: 0 reports for this device; peer average 2.37/device2024-11: 0 reports for this device; peer average 2.69/device2024-12: 0 reports for this device; peer average 2.83/device2025-01: 0 reports for this device; peer average 2.97/device2025-02: 0 reports for this device; peer average 3.08/device2025-03: 0 reports for this device; peer average 2.85/device2025-04: 0 reports for this device; peer average 2.71/device2025-05: 0 reports for this device; peer average 2.85/device2025-06: 0 reports for this device; peer average 3.2/device2025-07: 0 reports for this device; peer average 3.11/device2025-08: 0 reports for this device; peer average 3.08/device2025-09: 0 reports for this device; peer average 2.96/device2025-10: 0 reports for this device; peer average 3.04/device2025-11: 0 reports for this device; peer average 3.31/device2025-12: 0 reports for this device; peer average 3.85/device2026-01: 0 reports for this device; peer average 3.53/device2026-02: 0 reports for this device; peer average 3.5/device2026-03: 0 reports for this device; peer average 3.32/device2026-04: 0 reports for this device; peer average 3.31/device2026-05: 0 reports for this device; peer average 3.31/device2026-06: 0 reports for this device; peer average 3.55/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.43
2019-0201.88
2019-0301.74
2019-0402.26
2019-0501.81
2019-0601.93
2019-0702.53
2019-0802.09
2019-0901.87
2019-1002.74
2019-1101.94
2019-1202.04
2020-0102.8
2020-0202.14
2020-0302.24
2020-0402.75
2020-0502.13
2020-0602.32
2020-0703.12
2020-0802.29
2020-0902.28
2020-1003.12
2020-1102.19
2020-1202.55
2021-0102.46
2021-0202.6
2021-0302.51
2021-0402.41
2021-0502.68
2021-0602.53
2021-0702.44
2021-0802.48
2021-0902.34
2021-1002.46
2021-1102.27
2021-1202.34
2022-0102.34
2022-0202.36
2022-0302.3
2022-0402.3
2022-0502.13
2022-0602.3
2022-0702.22
2022-0802.42
2022-0902.18
2022-1002.29
2022-1102.13
2022-1202.18
2023-0102.15
2023-0202.12
2023-0302.28
2023-0402.26
2023-0501.95
2023-0602.25
2023-0702.22
2023-0801.86
2023-0901.85
2023-1002.14
2023-1102.18
2023-1202.12
2024-0101.85
2024-0201.92
2024-0301.84
2024-0402
2024-0501.97
2024-0602.05
2024-0702.06
2024-0801.97
2024-0902.11
2024-1002.37
2024-1102.69
2024-1202.83
2025-0102.97
2025-0203.08
2025-0302.85
2025-0402.71
2025-0502.85
2025-0603.2
2025-0703.11
2025-0803.08
2025-0902.96
2025-1003.04
2025-1103.31
2025-1203.85
2026-0103.53
2026-0203.5
2026-0303.32
2026-0403.31
2026-0503.31
2026-0603.55
This device (reports/month)Average device in DQY, LIT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K100921 — cites (transitively): K062809 (d1) — cited as predicate by K103464, K111899, K173515

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — MEDTRONIC, INC.

  • Warning Letter 2021-12-09 Medtronic MiniMed, Inc.
  • Warning Letter 2018-08-23 Medtronic Puerto Rico Operations Co.
  • Warning Letter 2018-07-30 Medtronic, Inc.
  • Warning Letter 2018-07-30 Medtronic, Inc.
  • Injunction 2015-04-29 Medtronic Neuromodulation
  • Warning Letter 2014-06-02 Heartware, Inc.
  • Warning Letter 2013-09-19 Medtronic MiniMed, Inc.
  • Warning Letter 2012-07-17 Medtronic Neuromodulation
  • Warning Letter 2010-05-07 Medtronic Navigation, Inc.
  • Warning Letter 2009-11-09 Medtronic, Inc.
  • NAI 2026-05-27 SPR Therapeutics Inc. · 0 citations
  • NAI 2026-02-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2025-12-15 MEDTRONIC GRAND RAPIDS · 2 citations
  • VAI 2025-11-11 Scientia Vascular, Inc. · 1 citations
  • NAI 2025-03-14 Medtronic Puerto Rico Operations Co. · 0 citations
  • VAI 2025-02-10 Medtronic, Inc. · 1 citations
  • VAI 2025-02-10 Medtronic, Inc. · 1 citations
  • NAI 2024-12-05 Medtronic Powered Surgical Solutions · 0 citations
  • VAI 2024-10-31 Medtronic CryoCath LP · 1 citations
  • NAI 2024-08-09 Medtronic, Inc. · 0 citations
  • NAI 2024-08-09 Medtronic, Inc. · 0 citations
  • VAI 2024-06-17 Medtronic Xomed, Inc. · 1 citations
  • VAI 2024-06-11 Medtronic Navigation, Inc.-Boxborough · 2 citations
  • VAI 2024-02-09 Medtronic Navigation, Inc. · 3 citations
  • NAI 2024-02-01 MEDTRONIC CARE MANAGEMENT SERVICES · 0 citations
  • NAI 2024-01-03 Medtronic MiniMed, Inc. · 0 citations
  • NAI 2023-09-01 Medtronic, Inc. · 0 citations
  • NAI 2023-09-01 Medtronic, Inc. · 0 citations
  • VAI 2023-05-05 Medtronic Neuromodulation · 4 citations
  • VAI 2023-03-10 Medtronic MiniMed, Inc. · 3 citations