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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.

224 linked reportsMalfunction 215Injury 9
4811152019-01: 5 reports for this device; peer average 4.33/device2019-04: 5 reports for this device; peer average 3.33/device2019-06: 1 reports for this device; peer average 1/device2019-07: 9 reports for this device; peer average 3.5/device2019-08: 0 reports for this device; peer average 2/device2019-10: 6 reports for this device; peer average 4.25/device2020-01: 6 reports for this device; peer average 4.5/device2020-02: 0 reports for this device; peer average 1/device2020-04: 7 reports for this device; peer average 3.75/device2020-07: 5 reports for this device; peer average 4/device2020-10: 6 reports for this device; peer average 4/device2020-11: 1 reports for this device; peer average 1/device2021-01: 15 reports for this device; peer average 7.5/device2021-02: 2 reports for this device; peer average 1.5/device2021-03: 1 reports for this device; peer average 1/device2021-04: 4 reports for this device; peer average 3.25/device2021-06: 1 reports for this device; peer average 1/device2021-07: 6 reports for this device; peer average 4.5/device2021-08: 0 reports for this device; peer average 1.5/device2021-09: 2 reports for this device; peer average 2/device2021-10: 6 reports for this device; peer average 3.5/device2022-01: 7 reports for this device; peer average 4.25/device2022-02: 1 reports for this device; peer average 1/device2022-04: 6 reports for this device; peer average 4.5/device2022-05: 1 reports for this device; peer average 1/device2022-07: 8 reports for this device; peer average 5/device2022-10: 6 reports for this device; peer average 4.5/device2023-01: 9 reports for this device; peer average 5.5/device2023-02: 1 reports for this device; peer average 1/device2023-03: 1 reports for this device; peer average 1/device2023-04: 8 reports for this device; peer average 5.5/device2023-05: 1 reports for this device; peer average 1/device2023-07: 10 reports for this device; peer average 6.75/device2023-10: 10 reports for this device; peer average 6.25/device2024-01: 8 reports for this device; peer average 5.5/device2024-03: 1 reports for this device; peer average 1/device2024-04: 9 reports for this device; peer average 4.75/device2024-07: 11 reports for this device; peer average 5.5/device2024-09: 1 reports for this device; peer average 1/device2024-10: 10 reports for this device; peer average 6.67/device2024-12: 0 reports for this device; peer average 1/device2025-01: 8 reports for this device; peer average 5/device2025-03: 0 reports for this device; peer average 1/device2025-04: 9 reports for this device; peer average 5/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1.5/device2025-10: 5 reports for this device; peer average 2.83/device2026-01: 3 reports for this device; peer average 2.2/device2026-04: 2 reports for this device; peer average 1.4/device01040607081001020407101101020304060708091001020405071001020304050710010304070910120103040607100104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0154.33
2019-0453.33
2019-0611
2019-0793.5
2019-0802
2019-1064.25
2020-0164.5
2020-0201
2020-0473.75
2020-0754
2020-1064
2020-1111
2021-01157.5
2021-0221.5
2021-0311
2021-0443.25
2021-0611
2021-0764.5
2021-0801.5
2021-0922
2021-1063.5
2022-0174.25
2022-0211
2022-0464.5
2022-0511
2022-0785
2022-1064.5
2023-0195.5
2023-0211
2023-0311
2023-0485.5
2023-0511
2023-07106.75
2023-10106.25
2024-0185.5
2024-0311
2024-0494.75
2024-07115.5
2024-0911
2024-10106.67
2024-1201
2025-0185
2025-0301
2025-0495
2025-0601
2025-0701.5
2025-1052.83
2026-0132.2
2026-0421.4
This device (reports/month)Average device in INK (reports/device/month)
Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2016-02-05Z-1184-2016Class IITerminatedThe 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.36clearance family
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-04-230001831750-2026-99210MalfunctionAvailableexact di
2026-04-230001831750-2026-99212MalfunctionAvailableexact di
2026-01-260001831750-2026-99067MalfunctionAvailableexact di
2026-01-260001831750-2026-99065MalfunctionAvailableexact di
2026-01-260001831750-2026-99069MalfunctionAvailableexact di
2025-10-270001831750-2025-99389MalfunctionAvailableexact di
2025-10-270001831750-2025-99425MalfunctionAvailableexact di
2025-10-270001831750-2025-99422MalfunctionAvailableexact di
2025-10-270001831750-2025-99382MalfunctionAvailableexact di
2025-10-270001831750-2025-99420MalfunctionAvailableexact di
2025-04-280001831750-2025-00563MalfunctionAvailableexact di
2025-04-250001831750-2025-00425MalfunctionAvailableexact di
2025-04-250001831750-2025-00429MalfunctionAvailableexact di
2025-04-250001831750-2025-00410MalfunctionAvailableexact di
2025-04-250001831750-2025-00436MalfunctionAvailableexact di

Showing the most recent 200 of 224 linked reports.

Showing 1–15 of 200
Regulatory clearances
  • 510(k)K140095Substantially equivalent (SESE) · 2014-05-20clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-06-18NAINo action indicatedInternational Life Sciences0
2026-02-20VAIVoluntary action indicatedStryker Puerto Rico, LLC2
2025-12-11NAINo action indicatedStryker Manufacturing Kalamazoo0
2025-05-22NAINo action indicatedStryker Macroom0
2025-03-27VAIVoluntary action indicatedStryker GmbH1
2025-03-27VAIVoluntary action indicatedStryker GmbH1
2025-02-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
2025-01-30NAINo action indicatedSerf0
2024-12-18VAIVoluntary action indicatedStryker Neurovascular1
2024-11-15VAIVoluntary action indicatedStryker Medical Division of Stryker Corporation2
2024-11-13NAINo action indicatedPOM Medical LLC0
2024-07-25VAIVoluntary action indicatedStryker Ireland, Ltd., Instruments Division1
2024-05-03NAINo action indicatedStryker Neurovascular, Inc.0
2024-04-18NAINo action indicatedPhysio-Control, Inc.0
2023-12-01VAIVoluntary action indicatedHowmedica Osteonics Corp.1
2023-05-15VAIVoluntary action indicatedLimFlow, Inc.2
2023-04-25NAINo action indicatedStryker Puerto Rico, LLC0
2023-01-24VAIVoluntary action indicatedStryker Corporation2
2023-01-24VAIVoluntary action indicatedStryker Corporation2
2022-03-08VAIVoluntary action indicatedPOM Medical LLC0
2017-04-06WLWarning LetterEntellus Medical Inc.—
2015-04-08WLWarning LetterThermedx LLC—
2013-11-26INJInjunctionPhysio-Control, Inc.—
2013-03-06WLWarning LetterStryker Corporation—
2013-03-06WLWarning LetterStryker Corporation—
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