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XprESS LoProfile

Model MSB&LLF · STRYKER CORPORATION · DI 00857326005017

LRC — Instrument, Ent Manual Surgical · Class I · 21 CFR 874.4420

PNZ — Eustachian Tube Balloon Dilation Device · Class II · 21 CFR 874.4180

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (3)

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.

Injury: 3

4811152019-01: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2.5/device2019-07: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1.4/device2019-10: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.57/device2020-01: 0 reports for this device; peer average 1.25/device2020-02: 0 reports for this device; peer average 2.33/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1.33/device2020-06: 0 reports for this device; peer average 3/device2020-08: 0 reports for this device; peer average 3/device2020-09: 1 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 2.14/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 5/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 15/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 3/device2023-03: 1 reports for this device; peer average 1.5/device2023-04: 0 reports for this device; peer average 3/device2023-05: 0 reports for this device; peer average 2.5/device2023-06: 0 reports for this device; peer average 6/device2023-08: 0 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1.5/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 3.33/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 11.75/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 3.5/device2024-10: 0 reports for this device; peer average 1.33/device2024-12: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 1.2/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 4/device2025-04: 0 reports for this device; peer average 4/device2025-05: 0 reports for this device; peer average 1.4/device2025-06: 0 reports for this device; peer average 1.33/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1.33/device2025-12: 1 reports for this device; peer average 1.5/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 1.33/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device010304070910120102030405060809111201020305070809101112010203060708091011120203040506081112010203040506070809101201020304050609101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0302
2019-0402.5
2019-0701
2019-0901.4
2019-1001
2019-1201.57
2020-0101.25
2020-0202.33
2020-0303
2020-0402
2020-0501.33
2020-0603
2020-0803
2020-0911
2020-1103
2020-1201
2021-0103
2021-0202
2021-0303
2021-0502
2021-0702
2021-0802.14
2021-0902
2021-1003
2021-1103
2021-1202
2022-0101
2022-0203
2022-0305
2022-0603
2022-0703
2022-0802
2022-0901
2022-1001
2022-11015
2022-1201
2023-0203
2023-0311.5
2023-0403
2023-0502.5
2023-0606
2023-0801.5
2023-1102
2023-1202
2024-0101.5
2024-0201.5
2024-0303.33
2024-0402
2024-05011.75
2024-0601.5
2024-0701
2024-0802
2024-0903.5
2024-1001.33
2024-1204
2025-0101.2
2025-0202
2025-0304
2025-0404
2025-0501.4
2025-0601.33
2025-0901
2025-1001
2025-1101.33
2025-1211.5
2026-0101
2026-0201.5
2026-0302
2026-0401.33
2026-0501
2026-0601
This device (reports/month)Average device in LRC, PNZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

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