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Penumbra System

Model 5MAXJET7 · PENUMBRA, INC. · DI 00814548019857

NRY — Catheter, Thrombus Retriever · 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 (2)

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: 2

13462019-01: 0 reports for this device; peer average 2.64/device2019-02: 0 reports for this device; peer average 3.27/device2019-03: 0 reports for this device; peer average 2.21/device2019-04: 0 reports for this device; peer average 2.4/device2019-05: 0 reports for this device; peer average 2.18/device2019-06: 0 reports for this device; peer average 3.28/device2019-07: 0 reports for this device; peer average 3.95/device2019-08: 0 reports for this device; peer average 3.9/device2019-09: 0 reports for this device; peer average 2.53/device2019-10: 0 reports for this device; peer average 3.61/device2019-11: 0 reports for this device; peer average 3.11/device2019-12: 0 reports for this device; peer average 3.55/device2020-01: 0 reports for this device; peer average 3.91/device2020-02: 0 reports for this device; peer average 5.88/device2020-03: 0 reports for this device; peer average 3.63/device2020-04: 0 reports for this device; peer average 3.42/device2020-05: 0 reports for this device; peer average 4.13/device2020-06: 0 reports for this device; peer average 3.5/device2020-07: 0 reports for this device; peer average 3.28/device2020-08: 0 reports for this device; peer average 3.71/device2020-09: 0 reports for this device; peer average 3.21/device2020-10: 1 reports for this device; peer average 3.89/device2020-11: 0 reports for this device; peer average 4.39/device2020-12: 0 reports for this device; peer average 4.48/device2021-01: 0 reports for this device; peer average 3.62/device2021-02: 0 reports for this device; peer average 3.65/device2021-03: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 3.29/device2021-05: 0 reports for this device; peer average 3.35/device2021-06: 0 reports for this device; peer average 2.53/device2021-07: 0 reports for this device; peer average 2.68/device2021-08: 0 reports for this device; peer average 3.19/device2021-09: 0 reports for this device; peer average 4/device2021-10: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 4.62/device2021-12: 0 reports for this device; peer average 4.36/device2022-01: 0 reports for this device; peer average 4.08/device2022-02: 0 reports for this device; peer average 5.7/device2022-03: 0 reports for this device; peer average 4.5/device2022-04: 0 reports for this device; peer average 2.69/device2022-05: 0 reports for this device; peer average 2.38/device2022-06: 0 reports for this device; peer average 3.81/device2022-07: 0 reports for this device; peer average 3.17/device2022-08: 0 reports for this device; peer average 1.84/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 3.67/device2022-11: 0 reports for this device; peer average 1.77/device2022-12: 0 reports for this device; peer average 3.07/device2023-01: 0 reports for this device; peer average 2.73/device2023-02: 0 reports for this device; peer average 2.82/device2023-03: 0 reports for this device; peer average 2.85/device2023-04: 0 reports for this device; peer average 2.62/device2023-05: 0 reports for this device; peer average 2.88/device2023-06: 0 reports for this device; peer average 3.52/device2023-07: 0 reports for this device; peer average 2.31/device2023-08: 0 reports for this device; peer average 3.3/device2023-09: 0 reports for this device; peer average 2.5/device2023-10: 0 reports for this device; peer average 3.17/device2023-11: 0 reports for this device; peer average 3.07/device2023-12: 0 reports for this device; peer average 2.79/device2024-01: 0 reports for this device; peer average 2.65/device2024-02: 0 reports for this device; peer average 3.08/device2024-03: 1 reports for this device; peer average 2.45/device2024-04: 0 reports for this device; peer average 3.24/device2024-05: 0 reports for this device; peer average 2.7/device2024-06: 0 reports for this device; peer average 1.73/device2024-07: 0 reports for this device; peer average 2.53/device2024-08: 0 reports for this device; peer average 3.2/device2024-09: 0 reports for this device; peer average 2.36/device2024-10: 0 reports for this device; peer average 2.81/device2024-11: 0 reports for this device; peer average 2.44/device2024-12: 0 reports for this device; peer average 2.55/device2025-01: 0 reports for this device; peer average 1.89/device2025-02: 0 reports for this device; peer average 2.82/device2025-03: 0 reports for this device; peer average 1.65/device2025-04: 0 reports for this device; peer average 3.24/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2.68/device2025-07: 0 reports for this device; peer average 2.21/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.88/device2025-10: 0 reports for this device; peer average 2.43/device2025-11: 0 reports for this device; peer average 1.6/device2025-12: 0 reports for this device; peer average 2.35/device2026-01: 0 reports for this device; peer average 1.94/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1.76/device2026-04: 0 reports for this device; peer average 4.18/device2026-05: 0 reports for this device; peer average 3.5/device2026-06: 0 reports for this device; peer average 2.58/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.64
2019-0203.27
2019-0302.21
2019-0402.4
2019-0502.18
2019-0603.28
2019-0703.95
2019-0803.9
2019-0902.53
2019-1003.61
2019-1103.11
2019-1203.55
2020-0103.91
2020-0205.88
2020-0303.63
2020-0403.42
2020-0504.13
2020-0603.5
2020-0703.28
2020-0803.71
2020-0903.21
2020-1013.89
2020-1104.39
2020-1204.48
2021-0103.62
2021-0203.65
2021-0303
2021-0403.29
2021-0503.35
2021-0602.53
2021-0702.68
2021-0803.19
2021-0904
2021-1004
2021-1104.62
2021-1204.36
2022-0104.08
2022-0205.7
2022-0304.5
2022-0402.69
2022-0502.38
2022-0603.81
2022-0703.17
2022-0801.84
2022-0902.82
2022-1003.67
2022-1101.77
2022-1203.07
2023-0102.73
2023-0202.82
2023-0302.85
2023-0402.62
2023-0502.88
2023-0603.52
2023-0702.31
2023-0803.3
2023-0902.5
2023-1003.17
2023-1103.07
2023-1202.79
2024-0102.65
2024-0203.08
2024-0312.45
2024-0403.24
2024-0502.7
2024-0601.73
2024-0702.53
2024-0803.2
2024-0902.36
2024-1002.81
2024-1102.44
2024-1202.55
2025-0101.89
2025-0202.82
2025-0301.65
2025-0403.24
2025-0502
2025-0602.68
2025-0702.21
2025-0801.5
2025-0901.88
2025-1002.43
2025-1101.6
2025-1202.35
2026-0101.94
2026-0202
2026-0301.76
2026-0404.18
2026-0503.5
2026-0602.58
This device (reports/month)Average device in NRY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K173761 — cites (transitively): K161640 (d1), K162901 (d1), K160449 (d2), K153071 (d2), K113455 (d3), K123378 (d3), K141491 (d3), K051758 (d3), K072718 (d3), K090752 (d3), K100769 (d3), K113163 (d3), K122756 (d3), K133317 (d3), K142458 (d3), K151623 (d3), K152541 (d3), K063774 (d4), K081305 (d4), K082034 (d4), K090085 (d4) — cited as predicate by K182522, K190010, K191946, K211654, K242104

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

Manufacturer compliance record — PENUMBRA, INC.

  • Warning Letter 2009-12-31 Penumbra Inc.
  • Warning Letter 2009-12-31 Penumbra Inc.
  • NAI 2021-06-21 Penumbra Inc. · 0 citations
  • NAI 2021-06-21 Penumbra Inc. · 0 citations
  • NAI 2017-02-13 Penumbra Inc. · 0 citations
  • NAI 2017-02-13 Penumbra Inc. · 0 citations
  • VAI 2016-02-23 Penumbra Inc. · 0 citations
  • VAI 2016-02-23 Penumbra Inc. · 0 citations
  • VAI 2015-08-04 Penumbra Inc. · 1 citations
  • VAI 2015-08-04 Penumbra Inc. · 1 citations
  • VAI 2015-07-15 Penumbra Inc. · 1 citations
  • VAI 2015-07-15 Penumbra Inc. · 1 citations
  • NAI 2014-04-30 Penumbra Inc. · 0 citations
  • NAI 2014-04-30 Penumbra Inc. · 0 citations
  • NAI 2012-02-27 Penumbra Inc. · 0 citations
  • NAI 2012-02-27 Penumbra Inc. · 0 citations
  • VAI 2010-08-24 Penumbra Inc. · 1 citations
  • VAI 2010-08-24 Penumbra Inc. · 1 citations