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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

  • European UnioniBur08858251002452SR
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.

2 linked reportsMalfunction 2
4811152019-01: 0 reports for this device; peer average 2.29/device2019-02: 0 reports for this device; peer average 3.68/device2019-03: 0 reports for this device; peer average 4.9/device2019-04: 0 reports for this device; peer average 3.39/device2019-05: 0 reports for this device; peer average 4/device2019-06: 0 reports for this device; peer average 3.65/device2019-07: 0 reports for this device; peer average 3.23/device2019-08: 0 reports for this device; peer average 3.89/device2019-09: 0 reports for this device; peer average 2.94/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 3.32/device2019-12: 0 reports for this device; peer average 3.76/device2020-01: 0 reports for this device; peer average 3.19/device2020-02: 0 reports for this device; peer average 6.36/device2020-03: 0 reports for this device; peer average 5.11/device2020-04: 0 reports for this device; peer average 3.12/device2020-05: 0 reports for this device; peer average 2.9/device2020-06: 0 reports for this device; peer average 4.24/device2020-07: 0 reports for this device; peer average 3.8/device2020-08: 0 reports for this device; peer average 3.06/device2020-09: 0 reports for this device; peer average 4.6/device2020-10: 0 reports for this device; peer average 3.78/device2020-11: 0 reports for this device; peer average 4.29/device2020-12: 0 reports for this device; peer average 4.34/device2021-01: 0 reports for this device; peer average 3.3/device2021-02: 0 reports for this device; peer average 3.03/device2021-03: 0 reports for this device; peer average 3.51/device2021-04: 0 reports for this device; peer average 2.92/device2021-05: 0 reports for this device; peer average 2.73/device2021-06: 0 reports for this device; peer average 3.62/device2021-07: 0 reports for this device; peer average 3.29/device2021-08: 0 reports for this device; peer average 4.9/device2021-09: 0 reports for this device; peer average 3.59/device2021-10: 0 reports for this device; peer average 2.88/device2021-11: 0 reports for this device; peer average 3.54/device2021-12: 0 reports for this device; peer average 4.3/device2022-01: 0 reports for this device; peer average 2.93/device2022-02: 0 reports for this device; peer average 3.79/device2022-03: 0 reports for this device; peer average 3.94/device2022-04: 0 reports for this device; peer average 2.55/device2022-05: 0 reports for this device; peer average 3.36/device2022-06: 0 reports for this device; peer average 3.9/device2022-07: 0 reports for this device; peer average 3.02/device2022-08: 0 reports for this device; peer average 3.9/device2022-09: 0 reports for this device; peer average 4.04/device2022-10: 0 reports for this device; peer average 3.41/device2022-11: 1 reports for this device; peer average 3.62/device2022-12: 0 reports for this device; peer average 4.61/device2023-01: 0 reports for this device; peer average 3.21/device2023-02: 0 reports for this device; peer average 3.83/device2023-03: 0 reports for this device; peer average 3.93/device2023-04: 0 reports for this device; peer average 3.25/device2023-05: 0 reports for this device; peer average 4.68/device2023-06: 0 reports for this device; peer average 4.04/device2023-07: 0 reports for this device; peer average 2.9/device2023-08: 0 reports for this device; peer average 3.5/device2023-09: 0 reports for this device; peer average 3.58/device2023-10: 0 reports for this device; peer average 2.62/device2023-11: 0 reports for this device; peer average 4.11/device2023-12: 1 reports for this device; peer average 2.85/device2024-01: 0 reports for this device; peer average 3.18/device2024-02: 0 reports for this device; peer average 3.13/device2024-03: 0 reports for this device; peer average 3.59/device2024-04: 0 reports for this device; peer average 2.68/device2024-05: 0 reports for this device; peer average 2.7/device2024-06: 0 reports for this device; peer average 3.29/device2024-07: 0 reports for this device; peer average 2.6/device2024-08: 0 reports for this device; peer average 2.75/device2024-09: 0 reports for this device; peer average 3.49/device2024-10: 0 reports for this device; peer average 2.67/device2024-11: 0 reports for this device; peer average 2.16/device2024-12: 0 reports for this device; peer average 3.35/device2025-01: 0 reports for this device; peer average 2.56/device2025-02: 0 reports for this device; peer average 3.52/device2025-03: 0 reports for this device; peer average 2.34/device2025-04: 0 reports for this device; peer average 1.85/device2025-05: 0 reports for this device; peer average 2.19/device2025-06: 0 reports for this device; peer average 2.48/device2025-07: 0 reports for this device; peer average 2.47/device2025-08: 0 reports for this device; peer average 1.85/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2.75/device2025-11: 0 reports for this device; peer average 3.08/device2025-12: 0 reports for this device; peer average 2.91/device2026-01: 0 reports for this device; peer average 2.01/device2026-02: 0 reports for this device; peer average 2.5/device2026-03: 0 reports for this device; peer average 4.3/device2026-04: 0 reports for this device; peer average 4.4/device2026-05: 0 reports for this device; peer average 4.84/device2026-06: 0 reports for this device; peer average 15.24/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.29
2019-0203.68
2019-0304.9
2019-0403.39
2019-0504
2019-0603.65
2019-0703.23
2019-0803.89
2019-0902.94
2019-1003
2019-1103.32
2019-1203.76
2020-0103.19
2020-0206.36
2020-0305.11
2020-0403.12
2020-0502.9
2020-0604.24
2020-0703.8
2020-0803.06
2020-0904.6
2020-1003.78
2020-1104.29
2020-1204.34
2021-0103.3
2021-0203.03
2021-0303.51
2021-0402.92
2021-0502.73
2021-0603.62
2021-0703.29
2021-0804.9
2021-0903.59
2021-1002.88
2021-1103.54
2021-1204.3
2022-0102.93
2022-0203.79
2022-0303.94
2022-0402.55
2022-0503.36
2022-0603.9
2022-0703.02
2022-0803.9
2022-0904.04
2022-1003.41
2022-1113.62
2022-1204.61
2023-0103.21
2023-0203.83
2023-0303.93
2023-0403.25
2023-0504.68
2023-0604.04
2023-0702.9
2023-0803.5
2023-0903.58
2023-1002.62
2023-1104.11
2023-1212.85
2024-0103.18
2024-0203.13
2024-0303.59
2024-0402.68
2024-0502.7
2024-0603.29
2024-0702.6
2024-0802.75
2024-0903.49
2024-1002.67
2024-1102.16
2024-1203.35
2025-0102.56
2025-0203.52
2025-0302.34
2025-0401.85
2025-0502.19
2025-0602.48
2025-0702.47
2025-0801.85
2025-0902
2025-1002.75
2025-1103.08
2025-1202.91
2026-0102.01
2026-0202.5
2026-0304.3
2026-0404.4
2026-0504.84
2026-06015.24
This device (reports/month)Average device in HBE (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-12-063015967359-2023-02552MalfunctionAvailableexact di
2022-11-113015967359-2022-02271MalfunctionAvailableexact di
Regulatory clearances

None linked.

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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