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.
16 linked reportsMalfunction 12Injury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 1 |
| 2019-06 | 0 | 1 |
| 2020-04 | 1 | 1 |
| 2020-07 | 1 | 1 |
| 2020-10 | 0 | 1 |
| 2021-01 | 3 | 3 |
| 2021-02 | 1 | 1 |
| 2021-03 | 1 | 1 |
| 2021-10 | 0 | 1 |
| 2022-01 | 1 | 1 |
| 2022-04 | 0 | 1 |
| 2023-02 | 0 | 5 |
| 2023-03 | 1 | 1.5 |
| 2023-04 | 1 | 1 |
| 2023-06 | 0 | 2 |
| 2023-10 | 0 | 1 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 2 |
| 2024-04 | 1 | 1 |
| 2024-06 | 0 | 1 |
| 2024-10 | 0 | 1 |
| 2025-01 | 1 | 1 |
| 2025-04 | 1 | 1 |
| 2025-06 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-11 | 0 | 6 |
| 2025-12 | 0 | 3 |
| 2026-01 | 1 | 1 |
| 2026-02 | 0 | 2 |
| 2026-04 | 1 | 1 |
| 2026-06 | 0 | 2 |
Failure-mode summaryAI-generated
16 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-05-12 | Z-2215-2021 | Class II | Open, Classified | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionalsDistribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand. | 1 unit | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-23 | 0001831750-2026-99230 | Malfunction | Available | exact di |
| 2026-01-27 | 0001831750-2026-99101 | Malfunction | Available | exact di |
| 2025-04-28 | 0001831750-2025-00471 | Malfunction | Available | exact di |
| 2025-01-27 | 0001831750-2025-00116 | Malfunction | Available | exact di |
| 2024-04-16 | 0001831750-2024-00367 | Injury | Available | exact di |
| 2023-04-26 | 0001831750-2023-00593 | Malfunction | Available | exact di |
| 2023-03-13 | 0001831750-2023-00311 | Injury | Available | exact di |
| 2022-01-19 | 0001831750-2022-00016 | Malfunction | Available | exact di |
| 2021-03-11 | 0001831750-2021-00661 | Injury | Available | exact di |
| 2021-02-01 | 0001831750-2021-00461 | Injury | Available | exact di |
| 2021-01-28 | 0001831750-2021-00378 | Malfunction | Available | exact di |
| 2021-01-22 | 0001831750-2021-00110 | Malfunction | Available | exact di |
| 2021-01-14 | 0001831750-2021-00018 | Malfunction | Available | exact di |
| 2020-07-22 | 0001831750-2020-00680 | Malfunction | Available | exact di |
| 2020-04-27 | 0001831750-2020-00402 | Malfunction | Available | exact di |
Showing 1–15 of 16
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-06-18 | NAI | No action indicated | International Life Sciences | 0 |
| 2026-02-20 | VAI | Voluntary action indicated | Stryker Puerto Rico, LLC | 2 |
| 2025-12-11 | NAI | No action indicated | Stryker Manufacturing Kalamazoo | 0 |
| 2025-05-22 | NAI | No action indicated | Stryker Macroom | 0 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-02-27 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
| 2025-01-30 | NAI | No action indicated | Serf | 0 |
| 2024-12-18 | VAI | Voluntary action indicated | Stryker Neurovascular | 1 |
| 2024-11-15 | VAI | Voluntary action indicated | Stryker Medical Division of Stryker Corporation | 2 |
| 2024-11-13 | NAI | No action indicated | POM Medical LLC | 0 |
| 2024-07-25 | VAI | Voluntary action indicated | Stryker Ireland, Ltd., Instruments Division | 1 |
| 2024-05-03 | NAI | No action indicated | Stryker Neurovascular, Inc. | 0 |
| 2024-04-18 | NAI | No action indicated | Physio-Control, Inc. | 0 |
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2023-05-15 | VAI | Voluntary action indicated | LimFlow, Inc. | 2 |
| 2023-04-25 | NAI | No action indicated | Stryker Puerto Rico, LLC | 0 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | POM Medical LLC | 0 |
| 2017-04-06 | WL | Warning Letter | Entellus Medical Inc. | — |
| 2015-04-08 | WL | Warning Letter | Thermedx LLC | — |
| 2013-11-26 | INJ | Injunction | Physio-Control, Inc. | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
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