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.
64 linked reportsMalfunction 62Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.33 |
| 2019-04 | 1 | 3.33 |
| 2019-06 | 0 | 1 |
| 2019-07 | 1 | 3.5 |
| 2019-08 | 0 | 2 |
| 2019-10 | 2 | 4.25 |
| 2020-01 | 3 | 4.5 |
| 2020-02 | 1 | 1 |
| 2020-04 | 3 | 3.75 |
| 2020-07 | 1 | 4 |
| 2020-10 | 2 | 4 |
| 2020-11 | 0 | 1 |
| 2021-01 | 1 | 7.5 |
| 2021-02 | 0 | 1.5 |
| 2021-03 | 0 | 1 |
| 2021-04 | 3 | 3.25 |
| 2021-06 | 0 | 1 |
| 2021-07 | 2 | 4.5 |
| 2021-08 | 0 | 1.5 |
| 2021-09 | 0 | 2 |
| 2021-10 | 1 | 3.5 |
| 2022-01 | 2 | 4.25 |
| 2022-02 | 0 | 1 |
| 2022-04 | 2 | 4.5 |
| 2022-05 | 0 | 1 |
| 2022-07 | 1 | 5 |
| 2022-10 | 3 | 4.5 |
| 2023-01 | 3 | 5.5 |
| 2023-02 | 0 | 1 |
| 2023-03 | 1 | 1 |
| 2023-04 | 5 | 5.5 |
| 2023-05 | 0 | 1 |
| 2023-07 | 3 | 6.75 |
| 2023-10 | 3 | 6.25 |
| 2024-01 | 4 | 5.5 |
| 2024-03 | 0 | 1 |
| 2024-04 | 2 | 4.75 |
| 2024-07 | 1 | 5.5 |
| 2024-09 | 0 | 1 |
| 2024-10 | 0 | 6.67 |
| 2024-12 | 0 | 1 |
| 2025-01 | 4 | 5 |
| 2025-03 | 0 | 1 |
| 2025-04 | 1 | 5 |
| 2025-06 | 0 | 1 |
| 2025-07 | 2 | 1.5 |
| 2025-10 | 2 | 2.83 |
| 2026-01 | 3 | 2.2 |
| 2026-04 | 1 | 1.4 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2016-02-05 | Z-1184-2016 | Class II | Terminated | The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events weDistribution: Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV. | 36 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-23 | 0001831750-2026-99211 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99073 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99075 | Malfunction | Available | exact di |
| 2026-01-26 | 0001831750-2026-99071 | Malfunction | Available | exact di |
| 2025-10-27 | 0001831750-2025-99395 | Malfunction | Available | exact di |
| 2025-10-27 | 0001831750-2025-99383 | Malfunction | Available | exact di |
| 2025-07-23 | 0001831750-2025-99066 | Malfunction | Available | exact di |
| 2025-07-23 | 0001831750-2025-99065 | Malfunction | Available | exact di |
| 2025-04-25 | 0001831750-2025-00430 | Malfunction | Available | exact di |
| 2025-01-27 | 0001831750-2025-00078 | Malfunction | Available | exact di |
| 2025-01-27 | 0001831750-2025-00083 | Malfunction | Available | exact di |
| 2025-01-27 | 0001831750-2025-00084 | Malfunction | Available | exact di |
| 2025-01-27 | 0001831750-2025-00063 | Malfunction | Available | exact di |
| 2024-07-29 | 0001831750-2024-01019 | Malfunction | Available | exact di |
| 2024-04-23 | 0001831750-2024-00624 | Malfunction | Available | exact di |
Showing 1–15 of 64
Regulatory clearances
- 510(k)K140095Substantially equivalent (SESE) · 2014-05-20clearance family
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 | — |
Similar devices
- BOUNDER Plus 21ST CENTURY SCIENTIFIC, INC.
- Electric Stretcher Hill-Rom de México, S. de R.L. de C.V.
- Sprint 200 L I N E T spol. s r.o.
- Sprint 200 L I N E T spol. s r.o.
- Sprint 200 L I N E T spol. s r.o.
- Sprint 200 L I N E T spol. s r.o.
- Sprint 200 L I N E T spol. s r.o.
- Sprint 200 L I N E T spol. s r.o.
- Sprint 200 L I N E T spol. s r.o.
- Sprint 200 L I N E T spol. s r.o.
- Sprint 200 L I N E T spol. s r.o.
- Sprint 200 L I N E T spol. s r.o.
Select up to two to place side-by-side with this device.