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.
102 linked reportsMalfunction 99Death 2Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.41 |
| 2019-02 | 0 | 1.71 |
| 2019-03 | 0 | 3 |
| 2019-04 | 0 | 2.46 |
| 2019-05 | 0 | 1.89 |
| 2019-06 | 0 | 2.33 |
| 2019-07 | 0 | 2.48 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 2.59 |
| 2019-11 | 0 | 1.8 |
| 2019-12 | 0 | 2.5 |
| 2020-01 | 0 | 2.8 |
| 2020-02 | 0 | 2.5 |
| 2020-03 | 0 | 1.17 |
| 2020-04 | 0 | 3 |
| 2020-05 | 0 | 2.8 |
| 2020-06 | 0 | 1.67 |
| 2020-07 | 0 | 2.92 |
| 2020-08 | 0 | 1.15 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 2.92 |
| 2020-11 | 0 | 2.25 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 4.96 |
| 2021-02 | 0 | 3.35 |
| 2021-03 | 0 | 1.67 |
| 2021-04 | 0 | 2.43 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 1.89 |
| 2021-07 | 0 | 2.47 |
| 2021-08 | 0 | 1.6 |
| 2021-09 | 0 | 1.2 |
| 2021-10 | 0 | 2.83 |
| 2021-11 | 0 | 1.17 |
| 2021-12 | 0 | 1.67 |
| 2022-01 | 0 | 2.72 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1.75 |
| 2022-04 | 0 | 3.1 |
| 2022-05 | 0 | 2.33 |
| 2022-06 | 0 | 1 |
| 2022-07 | 1 | 3.23 |
| 2022-08 | 0 | 1.75 |
| 2022-09 | 0 | 4 |
| 2022-10 | 4 | 3.29 |
| 2022-11 | 0 | 1.43 |
| 2022-12 | 0 | 2 |
| 2023-01 | 3 | 3.16 |
| 2023-02 | 0 | 1.67 |
| 2023-03 | 0 | 2.3 |
| 2023-04 | 4 | 3.68 |
| 2023-05 | 0 | 2.33 |
| 2023-06 | 0 | 2.4 |
| 2023-07 | 6 | 3.68 |
| 2023-08 | 0 | 1.63 |
| 2023-09 | 1 | 1.77 |
| 2023-10 | 4 | 3.5 |
| 2023-11 | 0 | 2.5 |
| 2023-12 | 0 | 2.4 |
| 2024-01 | 7 | 3.57 |
| 2024-02 | 1 | 3.17 |
| 2024-03 | 1 | 1.71 |
| 2024-04 | 7 | 4.21 |
| 2024-05 | 0 | 1.43 |
| 2024-06 | 2 | 2.3 |
| 2024-07 | 4 | 3.51 |
| 2024-08 | 0 | 1.57 |
| 2024-09 | 0 | 7 |
| 2024-10 | 7 | 4 |
| 2024-11 | 0 | 5.43 |
| 2024-12 | 0 | 4.6 |
| 2025-01 | 10 | 3.77 |
| 2025-02 | 0 | 6.67 |
| 2025-03 | 0 | 8 |
| 2025-04 | 9 | 3.81 |
| 2025-05 | 0 | 6 |
| 2025-06 | 0 | 3 |
| 2025-07 | 6 | 3.23 |
| 2025-08 | 0 | 5.67 |
| 2025-09 | 0 | 5 |
| 2025-10 | 6 | 3.47 |
| 2025-11 | 0 | 5.67 |
| 2025-12 | 1 | 3.22 |
| 2026-01 | 10 | 3.13 |
| 2026-02 | 1 | 4.67 |
| 2026-03 | 0 | 5.11 |
| 2026-04 | 7 | 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 |
|---|---|---|---|---|---|---|
| 2023-05-24 | Z-2130-2023 | Class II | Open, Classified | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Switzerland, United Kingdom. | 1,980 cots | code info di |
| 2023-02-01 | Z-1256-2023 | Class II | Open, Classified | Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.Distribution: US Nationwide distribution in the states of NY, VA. | 4 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-22 | 0001831750-2026-99176 | Malfunction | Available | exact di |
| 2026-04-22 | 0001831750-2026-99184 | Malfunction | Available | exact di |
| 2026-04-22 | 0001831750-2026-99185 | Malfunction | Available | exact di |
| 2026-04-22 | 0001831750-2026-99179 | Malfunction | Available | exact di |
| 2026-04-22 | 0001831750-2026-99190 | Malfunction | Available | exact di |
| 2026-04-22 | 0001831750-2026-99181 | Malfunction | Available | exact di |
| 2026-04-22 | 0001831750-2026-99175 | Malfunction | Available | exact di |
| 2026-02-19 | 0001831750-2026-00013 | Death | Available | exact di |
| 2026-01-28 | 0001831750-2026-99144 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99048 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99038 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99066 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99060 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99034 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99068 | Malfunction | Available | exact di |
Showing 1–15 of 102
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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