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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.

23 linked reportsMalfunction 21Injury 2
61218242019-01: 0 reports for this device; peer average 2.28/device2019-02: 0 reports for this device; peer average 3.62/device2019-03: 0 reports for this device; peer average 3.06/device2019-04: 0 reports for this device; peer average 2.95/device2019-05: 0 reports for this device; peer average 3.07/device2019-06: 0 reports for this device; peer average 4.81/device2019-07: 0 reports for this device; peer average 4/device2019-08: 0 reports for this device; peer average 3.93/device2019-09: 2 reports for this device; peer average 3.05/device2019-10: 0 reports for this device; peer average 3.33/device2019-11: 0 reports for this device; peer average 2.83/device2019-12: 2 reports for this device; peer average 2.78/device2020-01: 0 reports for this device; peer average 2.44/device2020-02: 0 reports for this device; peer average 3.2/device2020-03: 2 reports for this device; peer average 2.21/device2020-04: 0 reports for this device; peer average 2.47/device2020-05: 0 reports for this device; peer average 2.2/device2020-06: 0 reports for this device; peer average 2.81/device2020-07: 0 reports for this device; peer average 2.89/device2020-08: 2 reports for this device; peer average 2.53/device2020-09: 0 reports for this device; peer average 1.73/device2020-10: 0 reports for this device; peer average 5.04/device2020-11: 0 reports for this device; peer average 4.44/device2020-12: 0 reports for this device; peer average 6.7/device2021-01: 0 reports for this device; peer average 7.4/device2021-02: 0 reports for this device; peer average 4.53/device2021-03: 0 reports for this device; peer average 6.52/device2021-04: 0 reports for this device; peer average 4.84/device2021-05: 0 reports for this device; peer average 6.61/device2021-06: 0 reports for this device; peer average 8.08/device2021-07: 0 reports for this device; peer average 6.86/device2021-08: 0 reports for this device; peer average 6.06/device2021-09: 0 reports for this device; peer average 7.21/device2021-10: 0 reports for this device; peer average 5.75/device2021-11: 0 reports for this device; peer average 5.5/device2021-12: 0 reports for this device; peer average 8.15/device2022-01: 0 reports for this device; peer average 6.03/device2022-02: 0 reports for this device; peer average 6.3/device2022-03: 0 reports for this device; peer average 5/device2022-04: 0 reports for this device; peer average 7.24/device2022-05: 0 reports for this device; peer average 8.17/device2022-06: 0 reports for this device; peer average 6.32/device2022-07: 0 reports for this device; peer average 7.45/device2022-08: 0 reports for this device; peer average 4.54/device2022-09: 2 reports for this device; peer average 4.33/device2022-10: 0 reports for this device; peer average 4.23/device2022-11: 0 reports for this device; peer average 4.21/device2022-12: 0 reports for this device; peer average 5.88/device2023-01: 0 reports for this device; peer average 4.58/device2023-02: 0 reports for this device; peer average 4.48/device2023-03: 0 reports for this device; peer average 5.33/device2023-04: 0 reports for this device; peer average 3.83/device2023-05: 0 reports for this device; peer average 4.55/device2023-06: 0 reports for this device; peer average 4.16/device2023-07: 0 reports for this device; peer average 3.89/device2023-08: 0 reports for this device; peer average 3.92/device2023-09: 2 reports for this device; peer average 4.75/device2023-10: 0 reports for this device; peer average 5.21/device2023-11: 2 reports for this device; peer average 4.11/device2023-12: 0 reports for this device; peer average 4.26/device2024-01: 0 reports for this device; peer average 5.1/device2024-02: 0 reports for this device; peer average 3.81/device2024-03: 0 reports for this device; peer average 3.85/device2024-04: 0 reports for this device; peer average 3.91/device2024-05: 0 reports for this device; peer average 4.42/device2024-06: 1 reports for this device; peer average 5.19/device2024-07: 0 reports for this device; peer average 3.92/device2024-08: 0 reports for this device; peer average 6.67/device2024-09: 0 reports for this device; peer average 3.33/device2024-10: 2 reports for this device; peer average 4.91/device2024-11: 0 reports for this device; peer average 3.19/device2024-12: 0 reports for this device; peer average 3.08/device2025-01: 0 reports for this device; peer average 4.96/device2025-02: 0 reports for this device; peer average 3.31/device2025-03: 0 reports for this device; peer average 3.03/device2025-04: 0 reports for this device; peer average 4.38/device2025-05: 0 reports for this device; peer average 3.03/device2025-06: 0 reports for this device; peer average 4.96/device2025-07: 2 reports for this device; peer average 3.21/device2025-08: 0 reports for this device; peer average 4.68/device2025-09: 0 reports for this device; peer average 6.29/device2025-10: 0 reports for this device; peer average 10.59/device2025-11: 0 reports for this device; peer average 18.89/device2025-12: 0 reports for this device; peer average 24.25/device2026-01: 0 reports for this device; peer average 19.22/device2026-02: 0 reports for this device; peer average 10.89/device2026-03: 0 reports for this device; peer average 8.37/device2026-04: 2 reports for this device; peer average 12.95/device2026-05: 2 reports for this device; peer average 18.81/device2026-06: 0 reports for this device; peer average 13.59/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.28
2019-0203.62
2019-0303.06
2019-0402.95
2019-0503.07
2019-0604.81
2019-0704
2019-0803.93
2019-0923.05
2019-1003.33
2019-1102.83
2019-1222.78
2020-0102.44
2020-0203.2
2020-0322.21
2020-0402.47
2020-0502.2
2020-0602.81
2020-0702.89
2020-0822.53
2020-0901.73
2020-1005.04
2020-1104.44
2020-1206.7
2021-0107.4
2021-0204.53
2021-0306.52
2021-0404.84
2021-0506.61
2021-0608.08
2021-0706.86
2021-0806.06
2021-0907.21
2021-1005.75
2021-1105.5
2021-1208.15
2022-0106.03
2022-0206.3
2022-0305
2022-0407.24
2022-0508.17
2022-0606.32
2022-0707.45
2022-0804.54
2022-0924.33
2022-1004.23
2022-1104.21
2022-1205.88
2023-0104.58
2023-0204.48
2023-0305.33
2023-0403.83
2023-0504.55
2023-0604.16
2023-0703.89
2023-0803.92
2023-0924.75
2023-1005.21
2023-1124.11
2023-1204.26
2024-0105.1
2024-0203.81
2024-0303.85
2024-0403.91
2024-0504.42
2024-0615.19
2024-0703.92
2024-0806.67
2024-0903.33
2024-1024.91
2024-1103.19
2024-1203.08
2025-0104.96
2025-0203.31
2025-0303.03
2025-0404.38
2025-0503.03
2025-0604.96
2025-0723.21
2025-0804.68
2025-0906.29
2025-10010.59
2025-11018.89
2025-12024.25
2026-01019.22
2026-02010.89
2026-0308.37
2026-04212.95
2026-05218.81
2026-06013.59
This device (reports/month)Average device in FCG, ODG (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-05-223005099803-2026-02028MalfunctionAvailableexact di
2026-04-073005099803-2026-01258MalfunctionAvailableexact di
2025-07-103005099803-2025-03194InjuryAvailableexact di
2024-10-033005099803-2024-04886MalfunctionAvailableexact di
2024-06-0719483150MalfunctionAvailablemodel number
2023-11-083005099803-2023-06113MalfunctionAvailableexact di
2023-09-213005099803-2023-04961MalfunctionAvailableexact di
2022-09-013005099803-2022-04830MalfunctionAvailableexact di
2020-08-073005099803-2020-03097MalfunctionAvailableexact di
2020-03-043005099803-2020-00546MalfunctionAvailableexact di
2019-12-023005099803-2019-05828MalfunctionAvailableexact di
2019-09-173005099803-2019-04621MalfunctionAvailableexact di

Showing the most recent 12 of 23 linked reports.

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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