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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.

653 linked reportsMalfunction 593Injury 60
102030402019-01: 0 reports for this device; peer average 1.5/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 4.5/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 4 reports for this device; peer average 4/device2019-09: 1 reports for this device; peer average 1.75/device2019-10: 2 reports for this device; peer average 1.5/device2019-11: 8 reports for this device; peer average 8/device2019-12: 7 reports for this device; peer average 4/device2020-01: 3 reports for this device; peer average 1.75/device2020-02: 11 reports for this device; peer average 4.67/device2020-03: 5 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-08: 2 reports for this device; peer average 2/device2020-09: 2 reports for this device; peer average 3/device2020-10: 10 reports for this device; peer average 3.25/device2020-11: 3 reports for this device; peer average 2/device2020-12: 5 reports for this device; peer average 3.2/device2021-01: 3 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1.5/device2021-05: 2 reports for this device; peer average 2.5/device2021-06: 1 reports for this device; peer average 1/device2021-07: 4 reports for this device; peer average 2/device2021-08: 2 reports for this device; peer average 2/device2021-09: 1 reports for this device; peer average 1.5/device2021-10: 10 reports for this device; peer average 4.67/device2021-11: 0 reports for this device; peer average 1.67/device2021-12: 3 reports for this device; peer average 1.67/device2022-01: 10 reports for this device; peer average 3.75/device2022-02: 9 reports for this device; peer average 5/device2022-03: 7 reports for this device; peer average 5/device2022-04: 4 reports for this device; peer average 2.33/device2022-05: 4 reports for this device; peer average 3/device2022-06: 2 reports for this device; peer average 1.8/device2022-07: 3 reports for this device; peer average 2.6/device2022-08: 5 reports for this device; peer average 5/device2022-09: 14 reports for this device; peer average 4/device2022-10: 8 reports for this device; peer average 2.8/device2022-11: 1 reports for this device; peer average 1.33/device2022-12: 4 reports for this device; peer average 4.25/device2023-01: 0 reports for this device; peer average 1.67/device2023-02: 6 reports for this device; peer average 2.17/device2023-03: 5 reports for this device; peer average 1.83/device2023-04: 2 reports for this device; peer average 1.75/device2023-05: 0 reports for this device; peer average 2/device2023-06: 8 reports for this device; peer average 3.5/device2023-07: 3 reports for this device; peer average 2/device2023-08: 3 reports for this device; peer average 2/device2023-09: 2 reports for this device; peer average 1.67/device2023-10: 1 reports for this device; peer average 1.33/device2023-11: 3 reports for this device; peer average 2.5/device2023-12: 6 reports for this device; peer average 3/device2024-01: 4 reports for this device; peer average 2.67/device2024-02: 4 reports for this device; peer average 2.75/device2024-03: 7 reports for this device; peer average 3.8/device2024-04: 5 reports for this device; peer average 4.5/device2024-05: 2 reports for this device; peer average 1.33/device2024-06: 10 reports for this device; peer average 3.2/device2024-07: 3 reports for this device; peer average 3.33/device2024-08: 0 reports for this device; peer average 1.67/device2024-09: 5 reports for this device; peer average 5/device2024-10: 3 reports for this device; peer average 2/device2024-11: 6 reports for this device; peer average 2.83/device2024-12: 5 reports for this device; peer average 3/device2025-01: 19 reports for this device; peer average 10/device2025-02: 24 reports for this device; peer average 12.5/device2025-03: 20 reports for this device; peer average 8.33/device2025-04: 21 reports for this device; peer average 6.5/device2025-05: 40 reports for this device; peer average 11.75/device2025-06: 12 reports for this device; peer average 12/device2025-07: 12 reports for this device; peer average 5.25/device2025-08: 27 reports for this device; peer average 10/device2025-09: 13 reports for this device; peer average 7/device2025-10: 39 reports for this device; peer average 9/device2025-11: 36 reports for this device; peer average 10/device2025-12: 28 reports for this device; peer average 10.33/device2026-01: 20 reports for this device; peer average 5.75/device2026-02: 7 reports for this device; peer average 5.33/device2026-03: 21 reports for this device; peer average 11.5/device2026-04: 10 reports for this device; peer average 4/device2026-05: 25 reports for this device; peer average 11.67/device2026-06: 26 reports for this device; peer average 6.8/device01020304060708091011120102030406070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0201
2019-0302
2019-0404.5
2019-0601
2019-0701
2019-0844
2019-0911.75
2019-1021.5
2019-1188
2019-1274
2020-0131.75
2020-02114.67
2020-0353
2020-0401
2020-0601
2020-0701
2020-0822
2020-0923
2020-10103.25
2020-1132
2020-1253.2
2021-0132
2021-0201
2021-0302
2021-0401.5
2021-0522.5
2021-0611
2021-0742
2021-0822
2021-0911.5
2021-10104.67
2021-1101.67
2021-1231.67
2022-01103.75
2022-0295
2022-0375
2022-0442.33
2022-0543
2022-0621.8
2022-0732.6
2022-0855
2022-09144
2022-1082.8
2022-1111.33
2022-1244.25
2023-0101.67
2023-0262.17
2023-0351.83
2023-0421.75
2023-0502
2023-0683.5
2023-0732
2023-0832
2023-0921.67
2023-1011.33
2023-1132.5
2023-1263
2024-0142.67
2024-0242.75
2024-0373.8
2024-0454.5
2024-0521.33
2024-06103.2
2024-0733.33
2024-0801.67
2024-0955
2024-1032
2024-1162.83
2024-1253
2025-011910
2025-022412.5
2025-03208.33
2025-04216.5
2025-054011.75
2025-061212
2025-07125.25
2025-082710
2025-09137
2025-10399
2025-113610
2025-122810.33
2026-01205.75
2026-0275.33
2026-032111.5
2026-04104
2026-052511.67
2026-06266.8
This device (reports/month)Average device in FGX (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-2925650491MalfunctionAvailableexact di
2026-06-183005099803-2026-02517MalfunctionAvailableexact di
2026-06-163005099803-2026-02488InjuryAvailableexact di
2026-06-153005099803-2026-02464MalfunctionAvailableexact di
2026-06-153005099803-2026-02465MalfunctionAvailableexact di
2026-06-153005099803-2026-02440MalfunctionAvailableexact di
2026-06-113005099803-2026-02424MalfunctionAvailableexact di
2026-06-1125470502MalfunctionAvailablemodel number
2026-06-113005099803-2026-02423MalfunctionAvailableexact di
2026-06-093005099803-2026-02377MalfunctionAvailableexact di
2026-06-013005099803-2026-02250MalfunctionAvailableexact di
2026-05-2625276721MalfunctionAvailablemodel number
2026-05-193005099803-2026-01981MalfunctionAvailableexact di
2026-05-193005099803-2026-01982MalfunctionAvailableexact di
2026-05-193005099803-2026-01980MalfunctionAvailableexact di

Showing the most recent 200 of 653 linked reports.

Showing 1–15 of 200
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-04-07OAIOfficial action indicatedBoston Scientific Corporation9
2025-04-07OAIOfficial action indicatedBoston Scientific Corporation9
2025-03-18NAINo action indicatedBoston Scientific Corporation0
2025-03-18NAINo action indicatedBoston Scientific Corporation0
2024-12-06NAINo action indicatedNalu Medical, Inc.0
2024-11-26VAIVoluntary action indicatedBoston Scientific Corporation3
2024-11-26VAIVoluntary action indicatedBoston Scientific Corporation3
2024-06-13NAINo action indicatedElutia Inc0
2024-01-23VAIVoluntary action indicatedSilk Road Medical1
2023-12-05NAINo action indicatedValencia Technologies Corporation0
2023-12-01VAIVoluntary action indicatedCorbin Clinical Resources, Llc1
2023-08-01NAINo action indicatedBoston Scientific Corporation0
2023-08-01NAINo action indicatedBoston Scientific Corporation0
2023-04-05NAINo action indicatedIntera Oncology, Inc.0
2022-07-28NAINo action indicatedBoston Scientific Corporation0
2022-07-28NAINo action indicatedBoston Scientific Corporation0
2022-06-02VAIVoluntary action indicatedBoston Scientific de Costa Rica SRL0
2022-03-23NAINo action indicatedAxonics, Inc.0
2021-11-17VAIVoluntary action indicatedValencia Technologies Corporation1
2021-10-29NAINo action indicatedBoston Scientific Corporation0
2014-04-10WLWarning LetterBoston Scientific Corporation—
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