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.
220 linked reportsMalfunction 209Injury 11
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 8 | 3.24 |
| 2019-02 | 1 | 2.11 |
| 2019-03 | 1 | 1.39 |
| 2019-04 | 5 | 3.6 |
| 2019-05 | 1 | 3.28 |
| 2019-06 | 1 | 1.14 |
| 2019-07 | 7 | 3.44 |
| 2019-08 | 0 | 1.13 |
| 2019-09 | 0 | 1.25 |
| 2019-10 | 8 | 3.74 |
| 2019-11 | 0 | 1.33 |
| 2019-12 | 0 | 1.58 |
| 2020-01 | 8 | 3.57 |
| 2020-02 | 0 | 1.93 |
| 2020-03 | 0 | 2 |
| 2020-04 | 7 | 2.79 |
| 2020-05 | 0 | 1 |
| 2020-06 | 2 | 1.42 |
| 2020-07 | 7 | 4.9 |
| 2020-08 | 0 | 1.04 |
| 2020-09 | 1 | 3.67 |
| 2020-10 | 6 | 3.5 |
| 2020-11 | 0 | 1.07 |
| 2020-12 | 0 | 2.32 |
| 2021-01 | 21 | 8.24 |
| 2021-02 | 4 | 1.6 |
| 2021-03 | 1 | 2.03 |
| 2021-04 | 5 | 3.06 |
| 2021-05 | 0 | 6 |
| 2021-06 | 1 | 1.76 |
| 2021-07 | 6 | 2.34 |
| 2021-08 | 0 | 2.8 |
| 2021-09 | 1 | 1.81 |
| 2021-10 | 8 | 3.88 |
| 2021-11 | 0 | 2.08 |
| 2021-12 | 0 | 3.45 |
| 2022-01 | 8 | 3.65 |
| 2022-02 | 0 | 1.68 |
| 2022-03 | 0 | 1.83 |
| 2022-04 | 8 | 2.47 |
| 2022-05 | 0 | 1.41 |
| 2022-06 | 1 | 2.89 |
| 2022-07 | 7 | 3.76 |
| 2022-08 | 1 | 1.26 |
| 2022-09 | 0 | 2.33 |
| 2022-10 | 7 | 3.03 |
| 2022-11 | 0 | 2.31 |
| 2022-12 | 2 | 3.79 |
| 2023-01 | 7 | 2.25 |
| 2023-02 | 0 | 1.47 |
| 2023-03 | 0 | 3.27 |
| 2023-04 | 9 | 5.09 |
| 2023-05 | 1 | 6.26 |
| 2023-06 | 0 | 3.73 |
| 2023-07 | 5 | 5.07 |
| 2023-08 | 0 | 7.5 |
| 2023-09 | 0 | 5.9 |
| 2023-10 | 8 | 3.76 |
| 2023-11 | 0 | 8.22 |
| 2023-12 | 0 | 8.71 |
| 2024-01 | 6 | 4.85 |
| 2024-02 | 0 | 2.5 |
| 2024-03 | 0 | 7.12 |
| 2024-04 | 6 | 5.81 |
| 2024-05 | 0 | 7.91 |
| 2024-06 | 0 | 9.73 |
| 2024-07 | 6 | 5.69 |
| 2024-08 | 1 | 7.77 |
| 2024-09 | 0 | 6.57 |
| 2024-10 | 5 | 4.57 |
| 2024-11 | 0 | 13.53 |
| 2024-12 | 0 | 7.73 |
| 2025-01 | 5 | 7.04 |
| 2025-02 | 0 | 5.57 |
| 2025-03 | 1 | 4.91 |
| 2025-04 | 7 | 6.62 |
| 2025-05 | 0 | 5.12 |
| 2025-06 | 0 | 9.32 |
| 2025-07 | 0 | 6.46 |
| 2025-08 | 0 | 4.02 |
| 2025-09 | 0 | 9.07 |
| 2025-10 | 3 | 3.32 |
| 2025-11 | 0 | 8.51 |
| 2025-12 | 0 | 8.49 |
| 2026-01 | 3 | 4.16 |
| 2026-02 | 0 | 5.84 |
| 2026-03 | 0 | 6.43 |
| 2026-04 | 3 | 7.36 |
| 2026-05 | 0 | 21.67 |
| 2026-06 | 0 | 32.34 |
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-2216-2021 | 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. | 4 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-23 | 0001831750-2026-99234 | Malfunction | Available | exact di |
| 2026-04-23 | 0001831750-2026-99243 | Malfunction | Available | exact di |
| 2026-04-23 | 0001831750-2026-99235 | Malfunction | Available | exact di |
| 2026-01-27 | 0001831750-2026-99107 | Malfunction | Available | exact di |
| 2026-01-27 | 0001831750-2026-99106 | Malfunction | Available | exact di |
| 2026-01-27 | 0001831750-2026-99105 | Malfunction | Available | exact di |
| 2025-10-24 | 0001831750-2025-99256 | Malfunction | Available | exact di |
| 2025-10-24 | 0001831750-2025-99253 | Malfunction | Available | exact di |
| 2025-10-24 | 0001831750-2025-99250 | Malfunction | Available | exact di |
| 2025-04-28 | 0001831750-2025-00483 | Malfunction | Available | exact di |
| 2025-04-28 | 0001831750-2025-00484 | Malfunction | Available | exact di |
| 2025-04-28 | 0001831750-2025-00518 | Malfunction | Available | exact di |
| 2025-04-28 | 0001831750-2025-00481 | Malfunction | Available | exact di |
| 2025-04-28 | 0001831750-2025-00497 | Malfunction | Available | exact di |
| 2025-04-28 | 0001831750-2025-00514 | Malfunction | Available | exact di |
Showing the most recent 200 of 220 linked reports.
Showing 1–15 of 200
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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