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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.

4 linked reportsMalfunction 4
369122019-01: 0 reports for this device; peer average 9.09/device2019-02: 0 reports for this device; peer average 8.67/device2019-03: 0 reports for this device; peer average 9.14/device2019-04: 0 reports for this device; peer average 9.71/device2019-05: 0 reports for this device; peer average 8.27/device2019-06: 0 reports for this device; peer average 9.85/device2019-07: 0 reports for this device; peer average 10.06/device2019-08: 0 reports for this device; peer average 8.3/device2019-09: 0 reports for this device; peer average 8.69/device2019-10: 0 reports for this device; peer average 8.48/device2019-11: 0 reports for this device; peer average 8.73/device2019-12: 0 reports for this device; peer average 9.44/device2020-01: 0 reports for this device; peer average 9.16/device2020-02: 1 reports for this device; peer average 8.46/device2020-03: 0 reports for this device; peer average 8.75/device2020-04: 0 reports for this device; peer average 7.62/device2020-05: 0 reports for this device; peer average 6.91/device2020-06: 0 reports for this device; peer average 8.84/device2020-07: 0 reports for this device; peer average 9.47/device2020-08: 1 reports for this device; peer average 8.93/device2020-09: 0 reports for this device; peer average 10.11/device2020-10: 0 reports for this device; peer average 9.94/device2020-11: 0 reports for this device; peer average 9.74/device2020-12: 0 reports for this device; peer average 10.42/device2021-01: 0 reports for this device; peer average 9.01/device2021-02: 0 reports for this device; peer average 8.91/device2021-03: 0 reports for this device; peer average 8.85/device2021-04: 0 reports for this device; peer average 10.1/device2021-05: 0 reports for this device; peer average 9.44/device2021-06: 0 reports for this device; peer average 9.1/device2021-07: 0 reports for this device; peer average 9.03/device2021-08: 0 reports for this device; peer average 11.92/device2021-09: 0 reports for this device; peer average 10.3/device2021-10: 0 reports for this device; peer average 9.83/device2021-11: 0 reports for this device; peer average 8.38/device2021-12: 1 reports for this device; peer average 10.51/device2022-01: 0 reports for this device; peer average 8.84/device2022-02: 0 reports for this device; peer average 8.67/device2022-03: 0 reports for this device; peer average 9.34/device2022-04: 0 reports for this device; peer average 9.22/device2022-05: 0 reports for this device; peer average 9.47/device2022-06: 0 reports for this device; peer average 10.23/device2022-07: 0 reports for this device; peer average 9.31/device2022-08: 0 reports for this device; peer average 10.03/device2022-09: 0 reports for this device; peer average 8.87/device2022-10: 0 reports for this device; peer average 9.66/device2022-11: 0 reports for this device; peer average 9.94/device2022-12: 0 reports for this device; peer average 9.81/device2023-01: 0 reports for this device; peer average 9.1/device2023-02: 0 reports for this device; peer average 9.35/device2023-03: 0 reports for this device; peer average 11.91/device2023-04: 0 reports for this device; peer average 9.2/device2023-05: 1 reports for this device; peer average 9.02/device2023-06: 0 reports for this device; peer average 10.05/device2023-07: 0 reports for this device; peer average 9.97/device2023-08: 0 reports for this device; peer average 8.02/device2023-09: 0 reports for this device; peer average 7.6/device2023-10: 0 reports for this device; peer average 8.31/device2023-11: 0 reports for this device; peer average 7.91/device2023-12: 0 reports for this device; peer average 8.81/device2024-01: 0 reports for this device; peer average 9.15/device2024-02: 0 reports for this device; peer average 9.31/device2024-03: 0 reports for this device; peer average 7.38/device2024-04: 0 reports for this device; peer average 8.38/device2024-05: 0 reports for this device; peer average 6.88/device2024-06: 0 reports for this device; peer average 8.04/device2024-07: 0 reports for this device; peer average 8.06/device2024-08: 0 reports for this device; peer average 7.1/device2024-09: 0 reports for this device; peer average 9.47/device2024-10: 0 reports for this device; peer average 8.16/device2024-11: 0 reports for this device; peer average 9.42/device2024-12: 0 reports for this device; peer average 7.08/device2025-01: 0 reports for this device; peer average 8.53/device2025-02: 0 reports for this device; peer average 7.17/device2025-03: 0 reports for this device; peer average 7.01/device2025-04: 0 reports for this device; peer average 6.68/device2025-05: 0 reports for this device; peer average 8.68/device2025-06: 0 reports for this device; peer average 7.88/device2025-07: 0 reports for this device; peer average 10.29/device2025-08: 0 reports for this device; peer average 8.41/device2025-09: 0 reports for this device; peer average 8.36/device2025-10: 0 reports for this device; peer average 7.85/device2025-11: 0 reports for this device; peer average 8.37/device2025-12: 0 reports for this device; peer average 9.84/device2026-01: 0 reports for this device; peer average 8.94/device2026-02: 0 reports for this device; peer average 8.66/device2026-03: 0 reports for this device; peer average 9.11/device2026-04: 0 reports for this device; peer average 8.99/device2026-05: 0 reports for this device; peer average 8.2/device2026-06: 0 reports for this device; peer average 9.93/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0109.09
2019-0208.67
2019-0309.14
2019-0409.71
2019-0508.27
2019-0609.85
2019-07010.06
2019-0808.3
2019-0908.69
2019-1008.48
2019-1108.73
2019-1209.44
2020-0109.16
2020-0218.46
2020-0308.75
2020-0407.62
2020-0506.91
2020-0608.84
2020-0709.47
2020-0818.93
2020-09010.11
2020-1009.94
2020-1109.74
2020-12010.42
2021-0109.01
2021-0208.91
2021-0308.85
2021-04010.1
2021-0509.44
2021-0609.1
2021-0709.03
2021-08011.92
2021-09010.3
2021-1009.83
2021-1108.38
2021-12110.51
2022-0108.84
2022-0208.67
2022-0309.34
2022-0409.22
2022-0509.47
2022-06010.23
2022-0709.31
2022-08010.03
2022-0908.87
2022-1009.66
2022-1109.94
2022-1209.81
2023-0109.1
2023-0209.35
2023-03011.91
2023-0409.2
2023-0519.02
2023-06010.05
2023-0709.97
2023-0808.02
2023-0907.6
2023-1008.31
2023-1107.91
2023-1208.81
2024-0109.15
2024-0209.31
2024-0307.38
2024-0408.38
2024-0506.88
2024-0608.04
2024-0708.06
2024-0807.1
2024-0909.47
2024-1008.16
2024-1109.42
2024-1207.08
2025-0108.53
2025-0207.17
2025-0307.01
2025-0406.68
2025-0508.68
2025-0607.88
2025-07010.29
2025-0808.41
2025-0908.36
2025-1007.85
2025-1108.37
2025-1209.84
2026-0108.94
2026-0208.66
2026-0309.11
2026-0408.99
2026-0508.2
2026-0609.93
This device (reports/month)Average device in GDW, OCW (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-05-051219930-2023-01817MalfunctionAvailableexact di
2021-12-011219930-2021-04996MalfunctionAvailableexact di
2020-08-051219930-2020-03208MalfunctionAvailableexact di
2020-02-041219930-2020-00590MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-07-16NAINo action indicatedCovidien LLC0
2025-07-16NAINo action indicatedCovidien LLC0
2024-11-21NAINo action indicatedCovidien, LP0
2024-11-21NAINo action indicatedCovidien, LP0
2022-11-18VAIVoluntary action indicatedCovidien LP1
2022-11-18VAIVoluntary action indicatedCovidien LP1
2022-09-08VAIVoluntary action indicatedCovidien0
2022-09-08VAIVoluntary action indicatedCovidien0
2022-04-28OAIOfficial action indicatedCovidien2
2022-04-28OAIOfficial action indicatedCovidien2
2020-02-28VAIVoluntary action indicatedCovidien, LP1
2020-02-28VAIVoluntary action indicatedCovidien, LP1
2018-09-19NAINo action indicatedCovidien0
2018-09-19NAINo action indicatedCovidien0
2017-09-22VAIVoluntary action indicatedCovidien, LLC2
2017-09-22VAIVoluntary action indicatedCovidien, LLC2
2017-08-09NAINo action indicatedCovidien0
2017-08-09NAINo action indicatedCovidien0
2016-10-31NAINo action indicatedCovidien0
2016-10-31NAINo action indicatedCovidien0
2012-06-14WLWarning LetterCovidien, LP—
2012-06-14WLWarning LetterCovidien, LP—
2011-10-04WLWarning LetterOridion Medical 1987 Ltd.—
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