Skip to content
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.

21 linked reportsInjury 18Malfunction 3
24572019-01: 0 reports for this device; peer average 3/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 3/device2019-04: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 6/device2019-10: 6 reports for this device; peer average 5.33/device2019-11: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 6/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 4.8/device2020-08: 0 reports for this device; peer average 3/device2020-11: 0 reports for this device; peer average 2.67/device2021-01: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 4.5/device2021-05: 0 reports for this device; peer average 6.75/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2.67/device2021-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 3/device2022-01: 0 reports for this device; peer average 4.5/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 4.5/device2022-05: 0 reports for this device; peer average 6/device2022-06: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 3.6/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 6/device2023-04: 0 reports for this device; peer average 3/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 3/device2023-09: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 6/device2023-12: 0 reports for this device; peer average 6/device2024-05: 6 reports for this device; peer average 6/device2024-06: 0 reports for this device; peer average 2/device2024-07: 6 reports for this device; peer average 3.5/device2024-10: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 3.5/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 3/device2025-07: 0 reports for this device; peer average 7/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 4/device2025-10: 0 reports for this device; peer average 3/device2025-12: 3 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 2.5/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 6/device2026-06: 0 reports for this device; peer average 6/device010203040607091011010204060708110104050607080910111201020305060910010203040506091112050607100405060708091012010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0203
2019-0303
2019-0403
2019-0603
2019-0703
2019-0906
2019-1065.33
2019-1103
2020-0101
2020-0203
2020-0406
2020-0603
2020-0704.8
2020-0803
2020-1102.67
2021-0103
2021-0404.5
2021-0506.75
2021-0602
2021-0702.67
2021-0803
2021-0903
2021-1003
2021-1103
2021-1203
2022-0104.5
2022-0203
2022-0304.5
2022-0506
2022-0603
2022-0903
2022-1003.6
2023-0102
2023-0203
2023-0306
2023-0403
2023-0503
2023-0603
2023-0902
2023-1106
2023-1206
2024-0566
2024-0602
2024-0763.5
2024-1003
2025-0403.5
2025-0503
2025-0603
2025-0707
2025-0801.5
2025-0904
2025-1003
2025-1233
2026-0102.5
2026-0202
2026-0303
2026-0403
2026-0506
2026-0606
This device (reports/month)Average device in MAL (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-12-171640201-2025-0000031MalfunctionAvailablecatalog number
2024-07-152242352-2024-00804InjuryAvailablecatalog number
2024-07-121640201-2024-00012InjuryAvailablecatalog number
2024-05-072242352-2024-00490InjuryAvailablecatalog number
2024-05-031640201-2024-00004InjuryAvailablecatalog number
2019-10-172242352-2019-01136InjuryAvailablecatalog number
2019-10-081640201-2019-00079InjuryAvailablecatalog number

Showing the most recent 7 of 21 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2019-09-19VAIVoluntary action indicatedINTERVASCULAR, SAS3
2015-06-18NAINo action indicatedINTERVASCULAR, SAS0
Similar devices
Select up to two to place side-by-side with this device.