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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.

360 linked reportsMalfunction 356Injury 2Other 2
132638512019-01: 0 reports for this device; peer average 2.42/device2019-02: 11 reports for this device; peer average 3.53/device2019-03: 2 reports for this device; peer average 2.95/device2019-04: 1 reports for this device; peer average 3.13/device2019-05: 2 reports for this device; peer average 2.46/device2019-06: 2 reports for this device; peer average 3.58/device2019-07: 0 reports for this device; peer average 2.42/device2019-08: 1 reports for this device; peer average 2.47/device2019-09: 3 reports for this device; peer average 2.47/device2019-10: 0 reports for this device; peer average 2.71/device2019-11: 2 reports for this device; peer average 2.12/device2019-12: 3 reports for this device; peer average 2.35/device2020-01: 0 reports for this device; peer average 2.55/device2020-02: 3 reports for this device; peer average 2.7/device2020-03: 2 reports for this device; peer average 2.28/device2020-04: 0 reports for this device; peer average 2.54/device2020-05: 0 reports for this device; peer average 1.98/device2020-06: 1 reports for this device; peer average 2.78/device2020-07: 0 reports for this device; peer average 2.77/device2020-08: 3 reports for this device; peer average 4.33/device2020-09: 4 reports for this device; peer average 4.4/device2020-10: 0 reports for this device; peer average 3.99/device2020-11: 1 reports for this device; peer average 4.47/device2020-12: 2 reports for this device; peer average 3.87/device2021-01: 1 reports for this device; peer average 3.99/device2021-02: 0 reports for this device; peer average 3.89/device2021-03: 3 reports for this device; peer average 4.83/device2021-04: 3 reports for this device; peer average 4.7/device2021-05: 1 reports for this device; peer average 4.05/device2021-06: 2 reports for this device; peer average 4.28/device2021-07: 4 reports for this device; peer average 3.88/device2021-08: 8 reports for this device; peer average 3.87/device2021-09: 1 reports for this device; peer average 3.91/device2021-10: 2 reports for this device; peer average 3.99/device2021-11: 1 reports for this device; peer average 3.49/device2021-12: 2 reports for this device; peer average 4.46/device2022-01: 2 reports for this device; peer average 4.57/device2022-02: 3 reports for this device; peer average 5.03/device2022-03: 5 reports for this device; peer average 5.45/device2022-04: 3 reports for this device; peer average 6.48/device2022-05: 0 reports for this device; peer average 5.46/device2022-06: 2 reports for this device; peer average 6.07/device2022-07: 1 reports for this device; peer average 6.34/device2022-08: 5 reports for this device; peer average 6.38/device2022-09: 1 reports for this device; peer average 5.53/device2022-10: 6 reports for this device; peer average 5.35/device2022-11: 1 reports for this device; peer average 5.52/device2022-12: 0 reports for this device; peer average 6/device2023-01: 0 reports for this device; peer average 5.73/device2023-02: 1 reports for this device; peer average 4.87/device2023-03: 2 reports for this device; peer average 5.86/device2023-04: 3 reports for this device; peer average 5.47/device2023-05: 10 reports for this device; peer average 5.86/device2023-06: 2 reports for this device; peer average 7.1/device2023-07: 0 reports for this device; peer average 6.1/device2023-08: 3 reports for this device; peer average 6.28/device2023-09: 1 reports for this device; peer average 5.92/device2023-10: 0 reports for this device; peer average 6.38/device2023-11: 1 reports for this device; peer average 5.76/device2023-12: 0 reports for this device; peer average 6.05/device2024-01: 1 reports for this device; peer average 5.53/device2024-02: 0 reports for this device; peer average 6.18/device2024-03: 9 reports for this device; peer average 5.56/device2024-04: 4 reports for this device; peer average 6.32/device2024-05: 1 reports for this device; peer average 5.3/device2024-06: 2 reports for this device; peer average 7.07/device2024-07: 1 reports for this device; peer average 5.75/device2024-08: 5 reports for this device; peer average 6.5/device2024-09: 1 reports for this device; peer average 6.28/device2024-10: 6 reports for this device; peer average 7.11/device2024-11: 4 reports for this device; peer average 4.55/device2024-12: 2 reports for this device; peer average 4.77/device2025-01: 4 reports for this device; peer average 4.42/device2025-02: 2 reports for this device; peer average 4.03/device2025-03: 33 reports for this device; peer average 5.17/device2025-04: 51 reports for this device; peer average 4.67/device2025-05: 45 reports for this device; peer average 4.69/device2025-06: 18 reports for this device; peer average 4.58/device2025-07: 17 reports for this device; peer average 4.68/device2025-08: 6 reports for this device; peer average 5.45/device2025-09: 2 reports for this device; peer average 3.97/device2025-10: 1 reports for this device; peer average 4.59/device2025-11: 8 reports for this device; peer average 4.86/device2025-12: 4 reports for this device; peer average 6.15/device2026-01: 2 reports for this device; peer average 4.95/device2026-02: 6 reports for this device; peer average 5.05/device2026-03: 0 reports for this device; peer average 5.77/device2026-04: 1 reports for this device; peer average 6.2/device2026-05: 0 reports for this device; peer average 5.86/device2026-06: 1 reports for this device; peer average 5.01/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.42
2019-02113.53
2019-0322.95
2019-0413.13
2019-0522.46
2019-0623.58
2019-0702.42
2019-0812.47
2019-0932.47
2019-1002.71
2019-1122.12
2019-1232.35
2020-0102.55
2020-0232.7
2020-0322.28
2020-0402.54
2020-0501.98
2020-0612.78
2020-0702.77
2020-0834.33
2020-0944.4
2020-1003.99
2020-1114.47
2020-1223.87
2021-0113.99
2021-0203.89
2021-0334.83
2021-0434.7
2021-0514.05
2021-0624.28
2021-0743.88
2021-0883.87
2021-0913.91
2021-1023.99
2021-1113.49
2021-1224.46
2022-0124.57
2022-0235.03
2022-0355.45
2022-0436.48
2022-0505.46
2022-0626.07
2022-0716.34
2022-0856.38
2022-0915.53
2022-1065.35
2022-1115.52
2022-1206
2023-0105.73
2023-0214.87
2023-0325.86
2023-0435.47
2023-05105.86
2023-0627.1
2023-0706.1
2023-0836.28
2023-0915.92
2023-1006.38
2023-1115.76
2023-1206.05
2024-0115.53
2024-0206.18
2024-0395.56
2024-0446.32
2024-0515.3
2024-0627.07
2024-0715.75
2024-0856.5
2024-0916.28
2024-1067.11
2024-1144.55
2024-1224.77
2025-0144.42
2025-0224.03
2025-03335.17
2025-04514.67
2025-05454.69
2025-06184.58
2025-07174.68
2025-0865.45
2025-0923.97
2025-1014.59
2025-1184.86
2025-1246.15
2026-0124.95
2026-0265.05
2026-0305.77
2026-0416.2
2026-0505.86
2026-0615.01
This device (reports/month)Average device in GCJ (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2025-06-18Z-2170-2025Class IIOpen, ClassifiedDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Philippines, Singapore, China, Japan, Canada, Korea.N/Acode info di
2017-11-17Z-0835-2018Class IITerminatedRoutine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.Distribution: Distributed domestically to . Distributed internationally to Australia and Mexico.60,753 units totalcode info di
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-180002936485-2026-00388MalfunctionAvailableexact di
2026-04-020002936485-2026-00219MalfunctionAvailableexact di
2026-02-2724469501MalfunctionAvailablecatalog number
2026-02-1024304320MalfunctionAvailablecatalog number
2026-02-0324245409MalfunctionAvailablecatalog number
2026-01-160002936485-2026-00034MalfunctionAvailableexact di
2026-01-130002936485-2026-00024MalfunctionAvailableexact di
2025-12-230002936485-2025-01019MalfunctionAvailableexact di
2025-12-230002936485-2025-01016MalfunctionAvailableexact di
2025-12-230002936485-2025-01018MalfunctionAvailableexact di
2025-12-090002936485-2025-00972MalfunctionAvailableexact di
2025-11-2823671475MalfunctionAvailablecatalog number
2025-11-260002936485-2025-00942MalfunctionAvailableexact di
2025-11-2123616402MalfunctionAvailablecatalog number
2025-11-170002936485-2025-00923MalfunctionAvailableexact di

Showing the most recent 200 of 360 linked reports.

Showing 1–15 of 200
Regulatory clearances

None linked.

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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