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.
63 linked reportsInjury 52Malfunction 8Death 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.5 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.75 |
| 2019-04 | 0 | 3 |
| 2019-05 | 0 | 2.67 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 2.88 |
| 2019-08 | 0 | 2.25 |
| 2019-09 | 0 | 2.83 |
| 2019-10 | 0 | 2 |
| 2019-11 | 0 | 2.67 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 3.25 |
| 2020-02 | 0 | 3.5 |
| 2020-03 | 0 | 2.67 |
| 2020-04 | 0 | 2.25 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 2.2 |
| 2020-07 | 0 | 4.5 |
| 2020-08 | 3 | 3 |
| 2020-09 | 0 | 3.25 |
| 2020-10 | 3 | 3 |
| 2020-11 | 2 | 2.44 |
| 2020-12 | 0 | 3 |
| 2021-01 | 0 | 3 |
| 2021-02 | 4 | 5 |
| 2021-03 | 0 | 4.33 |
| 2021-04 | 0 | 3.14 |
| 2021-05 | 0 | 2.6 |
| 2021-06 | 0 | 3.6 |
| 2021-07 | 3 | 4 |
| 2021-08 | 0 | 2.6 |
| 2021-09 | 0 | 2.5 |
| 2021-10 | 0 | 4 |
| 2021-11 | 0 | 3 |
| 2021-12 | 0 | 2.2 |
| 2022-01 | 0 | 3 |
| 2022-02 | 0 | 2.82 |
| 2022-03 | 0 | 6 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 3.5 |
| 2022-06 | 3 | 2.78 |
| 2022-07 | 0 | 3.17 |
| 2022-08 | 0 | 3.67 |
| 2022-09 | 0 | 3.8 |
| 2022-10 | 0 | 2.67 |
| 2022-11 | 0 | 3.2 |
| 2022-12 | 0 | 3 |
| 2023-01 | 0 | 4 |
| 2023-02 | 0 | 2.6 |
| 2023-03 | 0 | 2.6 |
| 2023-04 | 6 | 4 |
| 2023-05 | 0 | 2.29 |
| 2023-06 | 3 | 2.75 |
| 2023-07 | 0 | 2.29 |
| 2023-08 | 3 | 2.6 |
| 2023-09 | 0 | 2.29 |
| 2023-10 | 0 | 4.25 |
| 2023-11 | 3 | 4.4 |
| 2023-12 | 3 | 2.25 |
| 2024-01 | 0 | 1.33 |
| 2024-02 | 0 | 3 |
| 2024-03 | 3 | 2.75 |
| 2024-04 | 0 | 3.5 |
| 2024-05 | 3 | 3.42 |
| 2024-06 | 6 | 3.4 |
| 2024-07 | 0 | 2.5 |
| 2024-08 | 0 | 3 |
| 2024-09 | 0 | 2.75 |
| 2024-10 | 0 | 1.67 |
| 2024-11 | 0 | 4.27 |
| 2024-12 | 0 | 2.33 |
| 2025-01 | 0 | 2.08 |
| 2025-02 | 3 | 2.5 |
| 2025-03 | 0 | 2.22 |
| 2025-04 | 0 | 3.25 |
| 2025-05 | 3 | 3.13 |
| 2025-06 | 0 | 3.56 |
| 2025-07 | 0 | 4.21 |
| 2025-08 | 3 | 3.5 |
| 2025-09 | 0 | 3.54 |
| 2025-10 | 0 | 2.84 |
| 2025-11 | 0 | 2.89 |
| 2025-12 | 0 | 2.18 |
| 2026-01 | 0 | 3.68 |
| 2026-02 | 0 | 4 |
| 2026-03 | 0 | 2.53 |
| 2026-04 | 3 | 2.88 |
| 2026-05 | 0 | 2.84 |
| 2026-06 | 3 | 5.37 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-01-13 | Z-1146-2021 | Class II | Terminated | Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.Distribution: U.S.: AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: None | Total = 455 systems | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-02 | 2124215-2026-29469 | Injury | Available | catalog number |
| 2026-04-13 | 2124215-2026-19763 | Malfunction | Available | catalog number |
| 2025-08-26 | 2124215-2025-58393 | Injury | Available | catalog number |
| 2025-05-23 | 2124215-2025-33462 | Injury | Available | catalog number |
| 2025-02-19 | 3014526664-2025-00027 | Malfunction | Available | catalog number |
| 2025-02-06 | MW5165750 | Injury | Available | model number |
| 2024-06-28 | 3014526664-2024-00128 | Injury | Available | catalog number |
| 2024-06-21 | 3014526664-2024-00126 | Injury | Available | catalog number |
| 2024-05-01 | 3014526664-2024-00084 | Injury | Available | catalog number |
| 2024-03-14 | 3014526664-2024-00056 | Injury | Available | catalog number |
| 2023-12-11 | 3014526664-2023-00216 | Injury | Available | catalog number |
| 2023-12-11 | 3014526664-2023-00205 | Injury | Available | exact di |
| 2023-11-09 | 3014526664-2023-00196 | Injury | Available | catalog number |
| 2023-08-08 | 3014526664-2023-00131 | Injury | Available | catalog number |
| 2023-06-14 | 3014526664-2023-00093 | Injury | Available | catalog number |
Showing the most recent 24 of 63 linked reports.
Showing 1–15 of 24
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-01-23 | VAI | Voluntary action indicated | Silk Road Medical | 1 |
| 2023-10-18 | NAI | No action indicated | Silk Road Medical Inc | 0 |
| 2020-02-27 | VAI | Voluntary action indicated | Silk Road Medical Inc | 1 |
| 2016-10-03 | NAI | No action indicated | Silk Road Medical Inc | 0 |
| 2016-06-23 | NAI | No action indicated | Silk Road Medical Inc | 0 |
| 2015-04-14 | VAI | Voluntary action indicated | Silk Road Medical Inc | 1 |
| 2014-07-11 | NAI | No action indicated | Silk Road Medical Inc | 0 |
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