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.
124 linked reportsInjury 66Malfunction 58
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 3 | 6.5 |
| 2019-02 | 3 | 4.38 |
| 2019-03 | 1 | 8.1 |
| 2019-04 | 10 | 10.93 |
| 2019-05 | 0 | 6.82 |
| 2019-06 | 3 | 7.85 |
| 2019-07 | 1 | 11.53 |
| 2019-08 | 2 | 9.71 |
| 2019-09 | 3 | 14.71 |
| 2019-10 | 7 | 11.63 |
| 2019-11 | 4 | 9.77 |
| 2019-12 | 1 | 9.6 |
| 2020-01 | 0 | 17.29 |
| 2020-02 | 0 | 14.6 |
| 2020-03 | 3 | 9.91 |
| 2020-04 | 4 | 14.76 |
| 2020-05 | 0 | 5.29 |
| 2020-06 | 1 | 7.86 |
| 2020-07 | 2 | 19.07 |
| 2020-08 | 3 | 7.11 |
| 2020-09 | 1 | 7 |
| 2020-10 | 1 | 26.67 |
| 2020-11 | 0 | 9.5 |
| 2020-12 | 2 | 8.95 |
| 2021-01 | 0 | 11.38 |
| 2021-02 | 0 | 18.95 |
| 2021-03 | 2 | 11.24 |
| 2021-04 | 4 | 9.75 |
| 2021-05 | 1 | 8 |
| 2021-06 | 0 | 14.19 |
| 2021-07 | 6 | 11.14 |
| 2021-08 | 2 | 8.06 |
| 2021-09 | 1 | 7.27 |
| 2021-10 | 1 | 6.26 |
| 2021-11 | 0 | 9.09 |
| 2021-12 | 4 | 8.44 |
| 2022-01 | 2 | 5.14 |
| 2022-02 | 1 | 4.74 |
| 2022-03 | 1 | 4.86 |
| 2022-04 | 2 | 6 |
| 2022-05 | 11 | 11.64 |
| 2022-06 | 4 | 4.77 |
| 2022-07 | 0 | 4.36 |
| 2022-08 | 2 | 4.7 |
| 2022-09 | 2 | 4 |
| 2022-10 | 0 | 3.17 |
| 2022-11 | 0 | 1.83 |
| 2022-12 | 0 | 4.44 |
| 2023-01 | 2 | 3.69 |
| 2023-02 | 0 | 3.4 |
| 2023-03 | 0 | 3.6 |
| 2023-04 | 2 | 2.83 |
| 2023-05 | 2 | 4 |
| 2023-06 | 0 | 7.22 |
| 2023-07 | 1 | 3.8 |
| 2023-08 | 2 | 3 |
| 2023-09 | 1 | 2.08 |
| 2023-10 | 0 | 3.78 |
| 2023-11 | 0 | 2.67 |
| 2023-12 | 0 | 4.78 |
| 2024-01 | 0 | 1.6 |
| 2024-02 | 0 | 3.2 |
| 2024-03 | 0 | 3.5 |
| 2024-04 | 1 | 3.57 |
| 2024-05 | 1 | 2.5 |
| 2024-06 | 0 | 4.17 |
| 2024-07 | 0 | 2.4 |
| 2024-08 | 0 | 3.14 |
| 2024-09 | 1 | 3 |
| 2024-10 | 1 | 2.83 |
| 2024-11 | 2 | 2.38 |
| 2024-12 | 0 | 4.4 |
| 2025-01 | 0 | 1.5 |
| 2025-02 | 1 | 1.57 |
| 2025-03 | 0 | 3.6 |
| 2025-04 | 1 | 1.57 |
| 2025-05 | 0 | 4.33 |
| 2025-06 | 0 | 4.2 |
| 2025-07 | 0 | 3.14 |
| 2025-08 | 0 | 2.75 |
| 2025-09 | 4 | 3.57 |
| 2025-10 | 0 | 3.8 |
| 2025-11 | 0 | 3.6 |
| 2025-12 | 1 | 2.83 |
| 2026-01 | 0 | 3.5 |
| 2026-02 | 0 | 4.2 |
| 2026-03 | 0 | 6.2 |
| 2026-04 | 0 | 2.25 |
| 2026-05 | 0 | 3.33 |
| 2026-06 | 0 | 2.25 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-02-14 | Z-0876-2022 | Class III | Terminated | IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse eventsDistribution: US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam | 52,590 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-10 | 3002808486-2025-00254 | Malfunction | Available | exact di |
| 2025-09-19 | 3005580113-2025-00048 | Injury | Available | catalog number |
| 2025-09-05 | 3002808486-2025-00195 | Injury | Available | exact di |
| 2025-04-29 | 3002808486-2025-00084 | Injury | Available | exact di |
| 2025-02-05 | 3002808486-2025-00022 | Malfunction | Available | exact di |
| 2024-11-12 | 3002808486-2024-00240 | Malfunction | Available | exact di |
| 2024-11-06 | 3005580113-2024-00079 | Injury | Available | exact di |
| 2024-10-25 | 3002808486-2024-00231 | Injury | Available | exact di |
| 2024-09-27 | 3002808486-2024-00196 | Malfunction | Available | exact di |
| 2024-05-14 | 3005580113-2024-00028 | Injury | Available | exact di |
| 2024-04-23 | 3002808486-2024-00069 | Injury | Available | exact di |
| 2023-09-28 | 3002808486-2023-00250 | Injury | Available | exact di |
| 2023-08-07 | 3005580113-2023-00104 | Injury | Available | exact di |
| 2023-08-02 | 3002808486-2023-00213 | Malfunction | Available | exact di |
| 2023-07-20 | 3002808486-2023-00204 | Malfunction | Available | exact di |
Showing the most recent 122 of 124 linked reports.
Showing 1–15 of 122
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2016-12-09 | VAI | Voluntary action indicated | William Cook Europe ApS | 2 |
| 2016-12-09 | VAI | Voluntary action indicated | William Cook Europe ApS | 2 |
| 2014-11-06 | NAI | No action indicated | William Cook Europe ApS | 0 |
| 2014-11-06 | NAI | No action indicated | William Cook Europe ApS | 0 |
| 2011-08-12 | NAI | No action indicated | William Cook Europe ApS | 0 |
| 2011-08-12 | NAI | No action indicated | William Cook Europe ApS | 0 |
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