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Penumbra System

Model ACE603D3MXSYS-A · PENUMBRA, INC. · DI 00815948020092

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

NRY — Catheter, Thrombus Retriever · Class II · 21 CFR 870.1250

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2017-06-09Z-2702-2017Class ITerminatedPenumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.k number procode

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 2.61/device2019-02: 0 reports for this device; peer average 2.09/device2019-03: 0 reports for this device; peer average 1.88/device2019-04: 0 reports for this device; peer average 2.37/device2019-05: 0 reports for this device; peer average 1.84/device2019-06: 0 reports for this device; peer average 2.09/device2019-07: 0 reports for this device; peer average 2.66/device2019-08: 0 reports for this device; peer average 2.26/device2019-09: 0 reports for this device; peer average 1.79/device2019-10: 0 reports for this device; peer average 2.8/device2019-11: 0 reports for this device; peer average 2.11/device2019-12: 0 reports for this device; peer average 2.24/device2020-01: 0 reports for this device; peer average 2.98/device2020-02: 0 reports for this device; peer average 2.51/device2020-03: 0 reports for this device; peer average 2.36/device2020-04: 0 reports for this device; peer average 2.7/device2020-05: 0 reports for this device; peer average 2.4/device2020-06: 0 reports for this device; peer average 2.44/device2020-07: 0 reports for this device; peer average 3.17/device2020-08: 0 reports for this device; peer average 2.44/device2020-09: 0 reports for this device; peer average 2.46/device2020-10: 0 reports for this device; peer average 3.19/device2020-11: 0 reports for this device; peer average 2.57/device2020-12: 0 reports for this device; peer average 2.83/device2021-01: 0 reports for this device; peer average 2.7/device2021-02: 0 reports for this device; peer average 2.66/device2021-03: 0 reports for this device; peer average 2.47/device2021-04: 0 reports for this device; peer average 2.32/device2021-05: 0 reports for this device; peer average 2.83/device2021-06: 0 reports for this device; peer average 2.46/device2021-07: 0 reports for this device; peer average 2.26/device2021-08: 0 reports for this device; peer average 2.57/device2021-09: 0 reports for this device; peer average 2.39/device2021-10: 0 reports for this device; peer average 2.48/device2021-11: 0 reports for this device; peer average 2.39/device2021-12: 0 reports for this device; peer average 2.48/device2022-01: 0 reports for this device; peer average 2.36/device2022-02: 0 reports for this device; peer average 2.44/device2022-03: 0 reports for this device; peer average 2.2/device2022-04: 0 reports for this device; peer average 2.3/device2022-05: 0 reports for this device; peer average 1.91/device2022-06: 0 reports for this device; peer average 2.42/device2022-07: 0 reports for this device; peer average 2.15/device2022-08: 0 reports for this device; peer average 2.29/device2022-09: 0 reports for this device; peer average 2.28/device2022-10: 0 reports for this device; peer average 2.41/device2022-11: 0 reports for this device; peer average 2.04/device2022-12: 0 reports for this device; peer average 2.04/device2023-01: 0 reports for this device; peer average 1.91/device2023-02: 0 reports for this device; peer average 2.11/device2023-03: 0 reports for this device; peer average 2.11/device2023-04: 0 reports for this device; peer average 2.22/device2023-05: 0 reports for this device; peer average 2.01/device2023-06: 0 reports for this device; peer average 2.34/device2023-07: 0 reports for this device; peer average 2.08/device2023-08: 0 reports for this device; peer average 2.06/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2.37/device2023-11: 0 reports for this device; peer average 2.52/device2023-12: 0 reports for this device; peer average 2.48/device2024-01: 0 reports for this device; peer average 1.93/device2024-02: 0 reports for this device; peer average 2.14/device2024-03: 0 reports for this device; peer average 1.91/device2024-04: 0 reports for this device; peer average 2.09/device2024-05: 0 reports for this device; peer average 2.04/device2024-06: 0 reports for this device; peer average 2.04/device2024-07: 0 reports for this device; peer average 2.08/device2024-08: 0 reports for this device; peer average 2.14/device2024-09: 0 reports for this device; peer average 2.1/device2024-10: 0 reports for this device; peer average 2.35/device2024-11: 0 reports for this device; peer average 2.42/device2024-12: 0 reports for this device; peer average 2.91/device2025-01: 0 reports for this device; peer average 2.75/device2025-02: 0 reports for this device; peer average 2.86/device2025-03: 0 reports for this device; peer average 2.53/device2025-04: 0 reports for this device; peer average 2.57/device2025-05: 0 reports for this device; peer average 2.57/device2025-06: 0 reports for this device; peer average 3.15/device2025-07: 0 reports for this device; peer average 3.09/device2025-08: 0 reports for this device; peer average 2.53/device2025-09: 0 reports for this device; peer average 2.77/device2025-10: 0 reports for this device; peer average 3.2/device2025-11: 0 reports for this device; peer average 2.99/device2025-12: 0 reports for this device; peer average 3.65/device2026-01: 0 reports for this device; peer average 3.28/device2026-02: 0 reports for this device; peer average 3.16/device2026-03: 0 reports for this device; peer average 3.1/device2026-04: 0 reports for this device; peer average 3.14/device2026-05: 0 reports for this device; peer average 3.42/device2026-06: 0 reports for this device; peer average 3.31/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.61
2019-0202.09
2019-0301.88
2019-0402.37
2019-0501.84
2019-0602.09
2019-0702.66
2019-0802.26
2019-0901.79
2019-1002.8
2019-1102.11
2019-1202.24
2020-0102.98
2020-0202.51
2020-0302.36
2020-0402.7
2020-0502.4
2020-0602.44
2020-0703.17
2020-0802.44
2020-0902.46
2020-1003.19
2020-1102.57
2020-1202.83
2021-0102.7
2021-0202.66
2021-0302.47
2021-0402.32
2021-0502.83
2021-0602.46
2021-0702.26
2021-0802.57
2021-0902.39
2021-1002.48
2021-1102.39
2021-1202.48
2022-0102.36
2022-0202.44
2022-0302.2
2022-0402.3
2022-0501.91
2022-0602.42
2022-0702.15
2022-0802.29
2022-0902.28
2022-1002.41
2022-1102.04
2022-1202.04
2023-0101.91
2023-0202.11
2023-0302.11
2023-0402.22
2023-0502.01
2023-0602.34
2023-0702.08
2023-0802.06
2023-0902
2023-1002.37
2023-1102.52
2023-1202.48
2024-0101.93
2024-0202.14
2024-0301.91
2024-0402.09
2024-0502.04
2024-0602.04
2024-0702.08
2024-0802.14
2024-0902.1
2024-1002.35
2024-1102.42
2024-1202.91
2025-0102.75
2025-0202.86
2025-0302.53
2025-0402.57
2025-0502.57
2025-0603.15
2025-0703.09
2025-0802.53
2025-0902.77
2025-1003.2
2025-1102.99
2025-1203.65
2026-0103.28
2026-0203.16
2026-0303.1
2026-0403.14
2026-0503.42
2026-0603.31
This device (reports/month)Average device in DQY, NRY (reports/device/month)

Regulatory clearances

  • K162901 SESE 2017-04-20 (k number procode)
  • K160449 SESE 2016-05-25 (k number procode)

Predicate lineage

K113163 — cites (transitively): K072718 (d1), K090752 (d1), K100769 (d1) — cited as predicate by K142458, K160449, K161506, K190338, K223913, K240917, K252707

K152840 — cites (transitively): K100826 (d1), K042568 (d2), K070970 (d2), K082290 (d2) — cited as predicate by K242033

K160449 — cites (transitively): K051758 (d1), K072718 (d1), K090752 (d1), K100769 (d1), K113163 (d1), K122756 (d1), K133317 (d1), K142458 (d1), K151623 (d1), K152541 (d1) — cited as predicate by K161506, K161640, K162901, K171332, K172448, K173841

K162901 — cites (transitively): K153071 (d1), K160449 (d1), K161640 (d1), K113455 (d2), K123378 (d2), K141491 (d2), K051758 (d2), K072718 (d2), K090752 (d2), K100769 (d2), K113163 (d2), K122756 (d2), K133317 (d2), K142458 (d2), K151623 (d2), K152541 (d2), K063774 (d3), K081305 (d3), K082034 (d3), K090085 (d3) — cited as predicate by K173761, K180008, K182522, K190464, K203440, K211411, K260599

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