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.
195 linked reportsMalfunction 190Injury 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 5 | 2.41 |
| 2019-02 | 0 | 1.71 |
| 2019-03 | 0 | 3 |
| 2019-04 | 4 | 2.46 |
| 2019-05 | 5 | 1.89 |
| 2019-06 | 0 | 2.33 |
| 2019-07 | 6 | 2.48 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 1 |
| 2019-10 | 6 | 2.59 |
| 2019-11 | 0 | 1.8 |
| 2019-12 | 0 | 2.5 |
| 2020-01 | 5 | 2.8 |
| 2020-02 | 0 | 2.5 |
| 2020-03 | 0 | 1.17 |
| 2020-04 | 5 | 3 |
| 2020-05 | 0 | 2.8 |
| 2020-06 | 0 | 1.67 |
| 2020-07 | 5 | 2.92 |
| 2020-08 | 1 | 1.15 |
| 2020-09 | 2 | 1.5 |
| 2020-10 | 5 | 2.92 |
| 2020-11 | 0 | 2.25 |
| 2020-12 | 0 | 1 |
| 2021-01 | 13 | 4.96 |
| 2021-02 | 2 | 3.35 |
| 2021-03 | 0 | 1.67 |
| 2021-04 | 2 | 2.43 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 1.89 |
| 2021-07 | 4 | 2.47 |
| 2021-08 | 0 | 1.6 |
| 2021-09 | 0 | 1.2 |
| 2021-10 | 2 | 2.83 |
| 2021-11 | 0 | 1.17 |
| 2021-12 | 0 | 1.67 |
| 2022-01 | 4 | 2.72 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1.75 |
| 2022-04 | 8 | 3.1 |
| 2022-05 | 0 | 2.33 |
| 2022-06 | 1 | 1 |
| 2022-07 | 6 | 3.23 |
| 2022-08 | 0 | 1.75 |
| 2022-09 | 0 | 4 |
| 2022-10 | 6 | 3.29 |
| 2022-11 | 1 | 1.43 |
| 2022-12 | 0 | 2 |
| 2023-01 | 7 | 3.16 |
| 2023-02 | 0 | 1.67 |
| 2023-03 | 1 | 2.3 |
| 2023-04 | 6 | 3.68 |
| 2023-05 | 0 | 2.33 |
| 2023-06 | 0 | 2.4 |
| 2023-07 | 7 | 3.68 |
| 2023-08 | 0 | 1.63 |
| 2023-09 | 0 | 1.77 |
| 2023-10 | 7 | 3.5 |
| 2023-11 | 0 | 2.5 |
| 2023-12 | 0 | 2.4 |
| 2024-01 | 8 | 3.57 |
| 2024-02 | 0 | 3.17 |
| 2024-03 | 0 | 1.71 |
| 2024-04 | 9 | 4.21 |
| 2024-05 | 0 | 1.43 |
| 2024-06 | 0 | 2.3 |
| 2024-07 | 7 | 3.51 |
| 2024-08 | 0 | 1.57 |
| 2024-09 | 0 | 7 |
| 2024-10 | 12 | 4 |
| 2024-11 | 0 | 5.43 |
| 2024-12 | 0 | 4.6 |
| 2025-01 | 7 | 3.77 |
| 2025-02 | 0 | 6.67 |
| 2025-03 | 0 | 8 |
| 2025-04 | 7 | 3.81 |
| 2025-05 | 0 | 6 |
| 2025-06 | 0 | 3 |
| 2025-07 | 4 | 3.23 |
| 2025-08 | 0 | 5.67 |
| 2025-09 | 0 | 5 |
| 2025-10 | 6 | 3.47 |
| 2025-11 | 0 | 5.67 |
| 2025-12 | 0 | 3.22 |
| 2026-01 | 4 | 3.13 |
| 2026-02 | 2 | 4.67 |
| 2026-03 | 0 | 5.11 |
| 2026-04 | 3 | 3.84 |
| 2026-05 | 0 | 10.43 |
| 2026-06 | 0 | 7.43 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-05-12 | Z-2208-2021 | 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 | 0001831750-2026-99207 | Malfunction | Available | exact di |
| 2026-04-23 | 0001831750-2026-99209 | Malfunction | Available | exact di |
| 2026-04-23 | 0001831750-2026-99206 | Malfunction | Available | exact di |
| 2026-02-24 | 0001831750-2026-00015 | Malfunction | Available | exact di |
| 2026-02-23 | 0001831750-2026-00014 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99035 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99037 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99033 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99063 | Malfunction | Available | exact di |
| 2025-10-27 | 0001831750-2025-99380 | Malfunction | Available | exact di |
| 2025-10-27 | 0001831750-2025-99381 | Malfunction | Available | exact di |
| 2025-10-27 | 0001831750-2025-99417 | Malfunction | Available | exact di |
| 2025-10-27 | 0001831750-2025-99369 | Malfunction | Available | exact di |
| 2025-10-27 | 0001831750-2025-99371 | Malfunction | Available | exact di |
| 2025-10-27 | 0001831750-2025-99413 | Malfunction | Available | exact di |
Showing the most recent 193 of 195 linked reports.
Showing 1–15 of 193
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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