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FlowGate2

Model 90495 · Stryker Corporation · DI 00815742004953

DQY — Catheter, Percutaneous · 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 (2)

InitiatedRecall #ClassStatusReasonLink basis
2024-04-23Z-1907-2024Class IIOpen, ClassifiedNeurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.code info di
2018-04-11Z-2569-2018Class IITerminatedThere may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device would be used, which could potentially prolong a procedure.k number procode

Adverse-event reports — MAUDE (83)

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: 78 · Injury: 5

23562019-01: 3 reports for this device; peer average 2.61/device2019-02: 1 reports for this device; peer average 1.91/device2019-03: 2 reports for this device; peer average 1.82/device2019-04: 3 reports for this device; peer average 2.36/device2019-05: 1 reports for this device; peer average 1.75/device2019-06: 4 reports for this device; peer average 1.88/device2019-07: 1 reports for this device; peer average 2.51/device2019-08: 0 reports for this device; peer average 1.98/device2019-09: 0 reports for this device; peer average 1.7/device2019-10: 0 reports for this device; peer average 2.7/device2019-11: 0 reports for this device; peer average 1.95/device2019-12: 2 reports for this device; peer average 2.02/device2020-01: 0 reports for this device; peer average 2.84/device2020-02: 0 reports for this device; peer average 2.03/device2020-03: 1 reports for this device; peer average 2.19/device2020-04: 2 reports for this device; peer average 2.62/device2020-05: 1 reports for this device; peer average 2/device2020-06: 1 reports for this device; peer average 2.3/device2020-07: 2 reports for this device; peer average 3.16/device2020-08: 1 reports for this device; peer average 2.25/device2020-09: 3 reports for this device; peer average 2.27/device2020-10: 0 reports for this device; peer average 3.12/device2020-11: 4 reports for this device; peer average 2.26/device2020-12: 2 reports for this device; peer average 2.59/device2021-01: 2 reports for this device; peer average 2.54/device2021-02: 1 reports for this device; peer average 2.54/device2021-03: 0 reports for this device; peer average 2.38/device2021-04: 4 reports for this device; peer average 2.24/device2021-05: 0 reports for this device; peer average 2.74/device2021-06: 1 reports for this device; peer average 2.46/device2021-07: 3 reports for this device; peer average 2.21/device2021-08: 0 reports for this device; peer average 2.49/device2021-09: 3 reports for this device; peer average 2.25/device2021-10: 0 reports for this device; peer average 2.36/device2021-11: 1 reports for this device; peer average 2.08/device2021-12: 1 reports for this device; peer average 2.26/device2022-01: 0 reports for this device; peer average 2.18/device2022-02: 3 reports for this device; peer average 2.17/device2022-03: 2 reports for this device; peer average 1.97/device2022-04: 1 reports for this device; peer average 2.25/device2022-05: 2 reports for this device; peer average 1.86/device2022-06: 1 reports for this device; peer average 2.22/device2022-07: 6 reports for this device; peer average 2.06/device2022-08: 1 reports for this device; peer average 2.37/device2022-09: 1 reports for this device; peer average 2.18/device2022-10: 1 reports for this device; peer average 2.2/device2022-11: 0 reports for this device; peer average 2.06/device2022-12: 2 reports for this device; peer average 1.92/device2023-01: 0 reports for this device; peer average 1.8/device2023-02: 0 reports for this device; peer average 1.96/device2023-03: 0 reports for this device; peer average 2.01/device2023-04: 0 reports for this device; peer average 2.13/device2023-05: 1 reports for this device; peer average 1.85/device2023-06: 0 reports for this device; peer average 2.11/device2023-07: 1 reports for this device; peer average 2.05/device2023-08: 1 reports for this device; peer average 1.85/device2023-09: 0 reports for this device; peer average 1.92/device2023-10: 0 reports for this device; peer average 2.21/device2023-11: 0 reports for this device; peer average 2.39/device2023-12: 0 reports for this device; peer average 2.42/device2024-01: 2 reports for this device; peer average 1.77/device2024-02: 0 reports for this device; peer average 1.96/device2024-03: 0 reports for this device; peer average 1.83/device2024-04: 0 reports for this device; peer average 1.92/device2024-05: 0 reports for this device; peer average 1.94/device2024-06: 0 reports for this device; peer average 2.12/device2024-07: 1 reports for this device; peer average 1.99/device2024-08: 0 reports for this device; peer average 1.97/device2024-09: 0 reports for this device; peer average 2.07/device2024-10: 0 reports for this device; peer average 2.28/device2024-11: 2 reports for this device; peer average 2.41/device2024-12: 0 reports for this device; peer average 2.97/device2025-01: 2 reports for this device; peer average 2.91/device2025-02: 0 reports for this device; peer average 2.87/device2025-03: 1 reports for this device; peer average 2.68/device2025-04: 1 reports for this device; peer average 2.49/device2025-05: 0 reports for this device; peer average 2.66/device2025-06: 0 reports for this device; peer average 3.23/device2025-07: 0 reports for this device; peer average 3.2/device2025-08: 0 reports for this device; peer average 2.73/device2025-09: 0 reports for this device; peer average 2.88/device2025-10: 0 reports for this device; peer average 3.24/device2025-11: 1 reports for this device; peer average 3.19/device2025-12: 0 reports for this device; peer average 3.84/device2026-01: 0 reports for this device; peer average 3.49/device2026-02: 0 reports for this device; peer average 3.34/device2026-03: 0 reports for this device; peer average 3.29/device2026-04: 0 reports for this device; peer average 3.06/device2026-05: 0 reports for this device; peer average 3.41/device2026-06: 0 reports for this device; peer average 3.38/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0132.61
2019-0211.91
2019-0321.82
2019-0432.36
2019-0511.75
2019-0641.88
2019-0712.51
2019-0801.98
2019-0901.7
2019-1002.7
2019-1101.95
2019-1222.02
2020-0102.84
2020-0202.03
2020-0312.19
2020-0422.62
2020-0512
2020-0612.3
2020-0723.16
2020-0812.25
2020-0932.27
2020-1003.12
2020-1142.26
2020-1222.59
2021-0122.54
2021-0212.54
2021-0302.38
2021-0442.24
2021-0502.74
2021-0612.46
2021-0732.21
2021-0802.49
2021-0932.25
2021-1002.36
2021-1112.08
2021-1212.26
2022-0102.18
2022-0232.17
2022-0321.97
2022-0412.25
2022-0521.86
2022-0612.22
2022-0762.06
2022-0812.37
2022-0912.18
2022-1012.2
2022-1102.06
2022-1221.92
2023-0101.8
2023-0201.96
2023-0302.01
2023-0402.13
2023-0511.85
2023-0602.11
2023-0712.05
2023-0811.85
2023-0901.92
2023-1002.21
2023-1102.39
2023-1202.42
2024-0121.77
2024-0201.96
2024-0301.83
2024-0401.92
2024-0501.94
2024-0602.12
2024-0711.99
2024-0801.97
2024-0902.07
2024-1002.28
2024-1122.41
2024-1202.97
2025-0122.91
2025-0202.87
2025-0312.68
2025-0412.49
2025-0502.66
2025-0603.23
2025-0703.2
2025-0802.73
2025-0902.88
2025-1003.24
2025-1113.19
2025-1203.84
2026-0103.49
2026-0203.34
2026-0303.29
2026-0403.06
2026-0503.41
2026-0603.38
This device (reports/month)Average device in DQY (reports/device/month)

Regulatory clearances

  • K153729 SESE 2016-01-27 (k number procode)

Predicate lineage

K153729 — cites (transitively): K122581 (d1), K131492 (d1), K112404 (d2), K122681 (d2) — cited as predicate by K190749, K192525, K193607, K200910, K203723, K212340, K221846, K232437

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

Manufacturer compliance record — Stryker Corporation

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
  • NAI 2026-06-18 International Life Sciences · 0 citations
  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations