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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.

154 linked reportsMalfunction 151Injury 3
71522292019-01: 0 reports for this device; peer average 15.25/device2019-02: 0 reports for this device; peer average 14/device2019-03: 0 reports for this device; peer average 13.5/device2019-04: 3 reports for this device; peer average 14.57/device2019-05: 1 reports for this device; peer average 9.46/device2019-06: 5 reports for this device; peer average 10.73/device2019-07: 1 reports for this device; peer average 12.08/device2019-08: 1 reports for this device; peer average 15/device2019-09: 0 reports for this device; peer average 29.2/device2019-10: 0 reports for this device; peer average 15.92/device2019-11: 1 reports for this device; peer average 17.63/device2019-12: 0 reports for this device; peer average 26.33/device2020-01: 2 reports for this device; peer average 17.89/device2020-02: 0 reports for this device; peer average 19.5/device2020-03: 1 reports for this device; peer average 24.4/device2020-04: 1 reports for this device; peer average 12.18/device2020-05: 1 reports for this device; peer average 12/device2020-06: 1 reports for this device; peer average 11/device2020-07: 0 reports for this device; peer average 9.4/device2020-08: 0 reports for this device; peer average 20.75/device2020-09: 1 reports for this device; peer average 16.3/device2020-10: 1 reports for this device; peer average 8.59/device2020-11: 1 reports for this device; peer average 17.88/device2020-12: 2 reports for this device; peer average 16.15/device2021-01: 0 reports for this device; peer average 14.3/device2021-02: 0 reports for this device; peer average 12.21/device2021-03: 1 reports for this device; peer average 9.41/device2021-04: 6 reports for this device; peer average 8.84/device2021-05: 1 reports for this device; peer average 9.8/device2021-06: 3 reports for this device; peer average 10.39/device2021-07: 0 reports for this device; peer average 6.81/device2021-08: 7 reports for this device; peer average 10/device2021-09: 1 reports for this device; peer average 10.78/device2021-10: 0 reports for this device; peer average 7.67/device2021-11: 1 reports for this device; peer average 8.64/device2021-12: 2 reports for this device; peer average 15.39/device2022-01: 0 reports for this device; peer average 8.12/device2022-02: 0 reports for this device; peer average 9.5/device2022-03: 3 reports for this device; peer average 9.5/device2022-04: 2 reports for this device; peer average 11.44/device2022-05: 0 reports for this device; peer average 16.29/device2022-06: 3 reports for this device; peer average 11.74/device2022-07: 0 reports for this device; peer average 13.15/device2022-08: 1 reports for this device; peer average 13.55/device2022-09: 5 reports for this device; peer average 8.5/device2022-10: 1 reports for this device; peer average 9.19/device2022-11: 0 reports for this device; peer average 19.36/device2022-12: 2 reports for this device; peer average 11.21/device2023-01: 0 reports for this device; peer average 13.89/device2023-02: 2 reports for this device; peer average 13.06/device2023-03: 4 reports for this device; peer average 12.74/device2023-04: 3 reports for this device; peer average 7.65/device2023-05: 4 reports for this device; peer average 9.84/device2023-06: 8 reports for this device; peer average 10.3/device2023-07: 4 reports for this device; peer average 15/device2023-08: 2 reports for this device; peer average 8.56/device2023-09: 1 reports for this device; peer average 11.24/device2023-10: 6 reports for this device; peer average 6.87/device2023-11: 5 reports for this device; peer average 9.27/device2023-12: 1 reports for this device; peer average 9.48/device2024-01: 5 reports for this device; peer average 9.57/device2024-02: 3 reports for this device; peer average 8.9/device2024-03: 4 reports for this device; peer average 8.81/device2024-04: 12 reports for this device; peer average 8.5/device2024-05: 1 reports for this device; peer average 7.73/device2024-06: 4 reports for this device; peer average 5.61/device2024-07: 2 reports for this device; peer average 6.87/device2024-08: 3 reports for this device; peer average 8.6/device2024-09: 5 reports for this device; peer average 12.95/device2024-10: 1 reports for this device; peer average 8.35/device2024-11: 3 reports for this device; peer average 6.25/device2024-12: 1 reports for this device; peer average 6.64/device2025-01: 2 reports for this device; peer average 6.41/device2025-02: 1 reports for this device; peer average 6.57/device2025-03: 1 reports for this device; peer average 5.43/device2025-04: 2 reports for this device; peer average 5.52/device2025-05: 1 reports for this device; peer average 5.39/device2025-06: 0 reports for this device; peer average 6.55/device2025-07: 1 reports for this device; peer average 6.13/device2025-08: 0 reports for this device; peer average 5.24/device2025-09: 0 reports for this device; peer average 5.87/device2025-10: 0 reports for this device; peer average 6.36/device2025-11: 0 reports for this device; peer average 5.96/device2025-12: 0 reports for this device; peer average 4.87/device2026-01: 0 reports for this device; peer average 4.15/device2026-02: 0 reports for this device; peer average 5.46/device2026-03: 0 reports for this device; peer average 5.55/device2026-04: 0 reports for this device; peer average 4.67/device2026-05: 0 reports for this device; peer average 4.21/device2026-06: 0 reports for this device; peer average 4.07/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01015.25
2019-02014
2019-03013.5
2019-04314.57
2019-0519.46
2019-06510.73
2019-07112.08
2019-08115
2019-09029.2
2019-10015.92
2019-11117.63
2019-12026.33
2020-01217.89
2020-02019.5
2020-03124.4
2020-04112.18
2020-05112
2020-06111
2020-0709.4
2020-08020.75
2020-09116.3
2020-1018.59
2020-11117.88
2020-12216.15
2021-01014.3
2021-02012.21
2021-0319.41
2021-0468.84
2021-0519.8
2021-06310.39
2021-0706.81
2021-08710
2021-09110.78
2021-1007.67
2021-1118.64
2021-12215.39
2022-0108.12
2022-0209.5
2022-0339.5
2022-04211.44
2022-05016.29
2022-06311.74
2022-07013.15
2022-08113.55
2022-0958.5
2022-1019.19
2022-11019.36
2022-12211.21
2023-01013.89
2023-02213.06
2023-03412.74
2023-0437.65
2023-0549.84
2023-06810.3
2023-07415
2023-0828.56
2023-09111.24
2023-1066.87
2023-1159.27
2023-1219.48
2024-0159.57
2024-0238.9
2024-0348.81
2024-04128.5
2024-0517.73
2024-0645.61
2024-0726.87
2024-0838.6
2024-09512.95
2024-1018.35
2024-1136.25
2024-1216.64
2025-0126.41
2025-0216.57
2025-0315.43
2025-0425.52
2025-0515.39
2025-0606.55
2025-0716.13
2025-0805.24
2025-0905.87
2025-1006.36
2025-1105.96
2025-1204.87
2026-0104.15
2026-0205.46
2026-0305.55
2026-0404.67
2026-0504.21
2026-0604.07
This device (reports/month)Average device in DWJ, FLL (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2018-09-06Z-0235-2019Class IITerminatedUsers may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filterDistribution: Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom389 unitscode info di
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-07-140001831750-2025-00715MalfunctionAvailableexact di
2025-05-150001831750-2025-00698MalfunctionAvailableexact di
2025-04-230001831750-2025-00349MalfunctionAvailableexact di
2025-04-040001831750-2025-00343MalfunctionAvailableexact di
2025-03-260001831750-2025-00341MalfunctionAvailableexact di
2025-02-120001831750-2025-00333MalfunctionAvailableexact di
2025-01-300001831750-2025-00316MalfunctionAvailableexact di
2025-01-100001831750-2025-00009MalfunctionAvailableexact di
2024-12-190001831750-2024-01411MalfunctionAvailableexact di
2024-11-220001831750-2024-01403MalfunctionAvailableexact di
2024-11-200001831750-2024-01401MalfunctionAvailableexact di
2024-11-070001831750-2024-01393MalfunctionAvailableexact di
2024-10-080001831750-2024-01078MalfunctionAvailableexact di
2024-09-260001831750-2024-01075MalfunctionAvailableexact di
2024-09-250001831750-2024-01074MalfunctionAvailableexact di

Showing the most recent 153 of 154 linked reports.

Showing 1–15 of 153
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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