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Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

102 linked reportsMalfunction 90Injury 12
25792019-01: 0 reports for this device; peer average 1.64/device2019-02: 0 reports for this device; peer average 1.52/device2019-03: 0 reports for this device; peer average 1.76/device2019-04: 0 reports for this device; peer average 1.69/device2019-05: 0 reports for this device; peer average 1.69/device2019-06: 0 reports for this device; peer average 1.55/device2019-07: 0 reports for this device; peer average 2.02/device2019-08: 0 reports for this device; peer average 2.38/device2019-09: 0 reports for this device; peer average 2.08/device2019-10: 0 reports for this device; peer average 2.24/device2019-11: 0 reports for this device; peer average 2.03/device2019-12: 0 reports for this device; peer average 2.52/device2020-01: 0 reports for this device; peer average 2.27/device2020-02: 0 reports for this device; peer average 2.9/device2020-03: 0 reports for this device; peer average 2.85/device2020-04: 0 reports for this device; peer average 2.16/device2020-05: 0 reports for this device; peer average 2.68/device2020-06: 0 reports for this device; peer average 2.46/device2020-07: 0 reports for this device; peer average 2.83/device2020-08: 0 reports for this device; peer average 2.54/device2020-09: 0 reports for this device; peer average 2.39/device2020-10: 0 reports for this device; peer average 2.62/device2020-11: 0 reports for this device; peer average 2.65/device2020-12: 0 reports for this device; peer average 2.71/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 2.12/device2021-03: 0 reports for this device; peer average 2.65/device2021-04: 0 reports for this device; peer average 2.6/device2021-05: 0 reports for this device; peer average 2.02/device2021-06: 0 reports for this device; peer average 2.4/device2021-07: 0 reports for this device; peer average 2.95/device2021-08: 0 reports for this device; peer average 2.36/device2021-09: 1 reports for this device; peer average 2.32/device2021-10: 0 reports for this device; peer average 1.97/device2021-11: 1 reports for this device; peer average 2.33/device2021-12: 5 reports for this device; peer average 2.59/device2022-01: 1 reports for this device; peer average 2.58/device2022-02: 4 reports for this device; peer average 2.37/device2022-03: 9 reports for this device; peer average 2.41/device2022-04: 2 reports for this device; peer average 2.51/device2022-05: 0 reports for this device; peer average 2.78/device2022-06: 3 reports for this device; peer average 2.69/device2022-07: 1 reports for this device; peer average 2.47/device2022-08: 1 reports for this device; peer average 2.92/device2022-09: 3 reports for this device; peer average 2.5/device2022-10: 1 reports for this device; peer average 2.18/device2022-11: 0 reports for this device; peer average 2.58/device2022-12: 1 reports for this device; peer average 2.33/device2023-01: 1 reports for this device; peer average 1.86/device2023-02: 2 reports for this device; peer average 2.53/device2023-03: 1 reports for this device; peer average 2.51/device2023-04: 3 reports for this device; peer average 2.18/device2023-05: 0 reports for this device; peer average 2.87/device2023-06: 1 reports for this device; peer average 2.34/device2023-07: 3 reports for this device; peer average 2.57/device2023-08: 4 reports for this device; peer average 2.62/device2023-09: 1 reports for this device; peer average 2.63/device2023-10: 2 reports for this device; peer average 2.51/device2023-11: 1 reports for this device; peer average 2.55/device2023-12: 0 reports for this device; peer average 2.68/device2024-01: 0 reports for this device; peer average 2.57/device2024-02: 1 reports for this device; peer average 2.6/device2024-03: 1 reports for this device; peer average 2.76/device2024-04: 0 reports for this device; peer average 2.2/device2024-05: 1 reports for this device; peer average 3.17/device2024-06: 0 reports for this device; peer average 2.94/device2024-07: 1 reports for this device; peer average 2.24/device2024-08: 3 reports for this device; peer average 3.44/device2024-09: 1 reports for this device; peer average 2.96/device2024-10: 1 reports for this device; peer average 3.8/device2024-11: 0 reports for this device; peer average 3.29/device2024-12: 0 reports for this device; peer average 3.67/device2025-01: 8 reports for this device; peer average 2.94/device2025-02: 3 reports for this device; peer average 3.07/device2025-03: 1 reports for this device; peer average 3.1/device2025-04: 1 reports for this device; peer average 3.32/device2025-05: 1 reports for this device; peer average 3.15/device2025-06: 0 reports for this device; peer average 2.88/device2025-07: 1 reports for this device; peer average 2.97/device2025-08: 3 reports for this device; peer average 3.12/device2025-09: 2 reports for this device; peer average 3.33/device2025-10: 1 reports for this device; peer average 3.11/device2025-11: 1 reports for this device; peer average 3.84/device2025-12: 4 reports for this device; peer average 4.14/device2026-01: 7 reports for this device; peer average 3.52/device2026-02: 3 reports for this device; peer average 3.82/device2026-03: 1 reports for this device; peer average 3.83/device2026-04: 0 reports for this device; peer average 2.94/device2026-05: 4 reports for this device; peer average 2.6/device2026-06: 0 reports for this device; peer average 2.77/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.64
2019-0201.52
2019-0301.76
2019-0401.69
2019-0501.69
2019-0601.55
2019-0702.02
2019-0802.38
2019-0902.08
2019-1002.24
2019-1102.03
2019-1202.52
2020-0102.27
2020-0202.9
2020-0302.85
2020-0402.16
2020-0502.68
2020-0602.46
2020-0702.83
2020-0802.54
2020-0902.39
2020-1002.62
2020-1102.65
2020-1202.71
2021-0103
2021-0202.12
2021-0302.65
2021-0402.6
2021-0502.02
2021-0602.4
2021-0702.95
2021-0802.36
2021-0912.32
2021-1001.97
2021-1112.33
2021-1252.59
2022-0112.58
2022-0242.37
2022-0392.41
2022-0422.51
2022-0502.78
2022-0632.69
2022-0712.47
2022-0812.92
2022-0932.5
2022-1012.18
2022-1102.58
2022-1212.33
2023-0111.86
2023-0222.53
2023-0312.51
2023-0432.18
2023-0502.87
2023-0612.34
2023-0732.57
2023-0842.62
2023-0912.63
2023-1022.51
2023-1112.55
2023-1202.68
2024-0102.57
2024-0212.6
2024-0312.76
2024-0402.2
2024-0513.17
2024-0602.94
2024-0712.24
2024-0833.44
2024-0912.96
2024-1013.8
2024-1103.29
2024-1203.67
2025-0182.94
2025-0233.07
2025-0313.1
2025-0413.32
2025-0513.15
2025-0602.88
2025-0712.97
2025-0833.12
2025-0923.33
2025-1013.11
2025-1113.84
2025-1244.14
2026-0173.52
2026-0233.82
2026-0313.83
2026-0402.94
2026-0542.6
2026-0602.77
This device (reports/month)Average device in DQX, MOF (reports/device/month)
Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-04-18Z-1940-2024Class IIOpen, ClassifiedStryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.Distribution: Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.41,074code info di
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-05-193012931345-2026-00091MalfunctionAvailableexact di
2026-05-133012931345-2026-00086MalfunctionAvailableexact di
2026-05-083012931345-2026-00084MalfunctionAvailableexact di
2026-05-083012931345-2026-00083MalfunctionAvailableexact di
2026-03-063012931345-2026-00042MalfunctionAvailableexact di
2026-02-163012931345-2026-00030MalfunctionAvailableexact di
2026-02-163012931345-2026-00032MalfunctionAvailableexact di
2026-02-163012931345-2026-00031MalfunctionAvailableexact di
2026-01-303012931345-2026-00018MalfunctionAvailableexact di
2026-01-303012931345-2026-00019MalfunctionAvailableexact di
2026-01-303012931345-2026-00020MalfunctionAvailableexact di
2026-01-173012931345-2026-00010MalfunctionAvailableexact di
2026-01-023012931345-2026-00002MalfunctionAvailableexact di
2026-01-023012931345-2026-00003MalfunctionAvailableexact di
2026-01-023012931345-2026-00001MalfunctionAvailableexact di

Showing the most recent 101 of 102 linked reports.

Showing 1–15 of 101
Regulatory clearances

    Predicate lineage

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2026-06-18NAINo action indicatedInternational Life Sciences0
    2026-02-20VAIVoluntary action indicatedStryker Puerto Rico, LLC2
    2025-12-11NAINo action indicatedStryker Manufacturing Kalamazoo0
    2025-05-22NAINo action indicatedStryker Macroom0
    2025-03-27VAIVoluntary action indicatedStryker GmbH1
    2025-03-27VAIVoluntary action indicatedStryker GmbH1
    2025-02-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
    2025-01-30NAINo action indicatedSerf0
    2024-12-18VAIVoluntary action indicatedStryker Neurovascular1
    2024-11-15VAIVoluntary action indicatedStryker Medical Division of Stryker Corporation2
    2024-11-13NAINo action indicatedPOM Medical LLC0
    2024-07-25VAIVoluntary action indicatedStryker Ireland, Ltd., Instruments Division1
    2024-05-03NAINo action indicatedStryker Neurovascular, Inc.0
    2024-04-18NAINo action indicatedPhysio-Control, Inc.0
    2023-12-01VAIVoluntary action indicatedHowmedica Osteonics Corp.1
    2023-05-15VAIVoluntary action indicatedLimFlow, Inc.2
    2023-04-25NAINo action indicatedStryker Puerto Rico, LLC0
    2023-01-24VAIVoluntary action indicatedStryker Corporation2
    2023-01-24VAIVoluntary action indicatedStryker Corporation2
    2022-03-08VAIVoluntary action indicatedPOM Medical LLC0
    2017-04-06WLWarning LetterEntellus Medical Inc.—
    2015-04-08WLWarning LetterThermedx LLC—
    2013-11-26INJInjunctionPhysio-Control, Inc.—
    2013-03-06WLWarning LetterStryker Corporation—
    2013-03-06WLWarning LetterStryker Corporation—
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