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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 UnionFlyte08858250000483S5
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.

4 linked reportsMalfunction 4
01112019-07: 1 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-04: 1 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2022-01: 1 reports for this device; peer average 1/device2022-04: 1 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device07100102100104100104070707
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0711
2019-1001
2020-0101
2020-0201
2020-1001
2021-0101
2021-0411
2021-1001
2022-0111
2022-0411
2022-0701
2023-0701
2025-0701
This device (reports/month)Average device in FXZ (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2022-04-253015967359-2022-00744MalfunctionAvailableexact di
2022-01-193015967359-2022-00085MalfunctionAvailableexact di
2021-04-263015967359-2021-00547MalfunctionAvailableexact di
2019-07-230001811755-2019-02384MalfunctionAvailableexact 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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