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.
37 linked reportsMalfunction 34Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 2 | 1.33 |
| 2019-02 | 0 | 1.6 |
| 2019-03 | 0 | 8.8 |
| 2019-04 | 0 | 2.5 |
| 2019-05 | 1 | 5.43 |
| 2019-06 | 0 | 3.5 |
| 2019-07 | 0 | 7 |
| 2019-08 | 2 | 3.33 |
| 2019-09 | 2 | 6.5 |
| 2019-10 | 2 | 4.38 |
| 2019-11 | 0 | 5 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 26.25 |
| 2020-02 | 0 | 9.5 |
| 2020-03 | 0 | 6.8 |
| 2020-04 | 0 | 2.57 |
| 2020-05 | 0 | 5.67 |
| 2020-06 | 0 | 3.5 |
| 2020-07 | 0 | 5.11 |
| 2020-08 | 0 | 5 |
| 2020-09 | 0 | 8 |
| 2020-10 | 2 | 3.13 |
| 2020-11 | 0 | 7.29 |
| 2020-12 | 0 | 9.67 |
| 2021-01 | 0 | 6.2 |
| 2021-02 | 0 | 7.17 |
| 2021-03 | 0 | 11.5 |
| 2021-04 | 0 | 12 |
| 2021-05 | 0 | 8.33 |
| 2021-06 | 0 | 13.17 |
| 2021-07 | 0 | 11.17 |
| 2021-08 | 0 | 13 |
| 2021-09 | 0 | 10.33 |
| 2021-10 | 3 | 11.33 |
| 2021-11 | 0 | 16.2 |
| 2021-12 | 0 | 12.4 |
| 2022-01 | 0 | 15.2 |
| 2022-02 | 0 | 9.6 |
| 2022-03 | 3 | 9.86 |
| 2022-04 | 0 | 7.67 |
| 2022-05 | 0 | 23.67 |
| 2022-06 | 0 | 11.2 |
| 2022-07 | 0 | 13.8 |
| 2022-08 | 0 | 11.63 |
| 2022-09 | 0 | 10.83 |
| 2022-10 | 0 | 8.71 |
| 2022-11 | 0 | 12.5 |
| 2022-12 | 0 | 13 |
| 2023-01 | 2 | 6 |
| 2023-02 | 0 | 11.67 |
| 2023-03 | 0 | 14.8 |
| 2023-04 | 0 | 16.5 |
| 2023-05 | 0 | 11.2 |
| 2023-06 | 0 | 8.5 |
| 2023-07 | 0 | 17 |
| 2023-08 | 1 | 6.38 |
| 2023-09 | 0 | 14.6 |
| 2023-10 | 8 | 17.25 |
| 2023-11 | 0 | 12.2 |
| 2023-12 | 0 | 13.5 |
| 2024-01 | 0 | 13.83 |
| 2024-02 | 0 | 17.5 |
| 2024-03 | 0 | 11.5 |
| 2024-04 | 0 | 10 |
| 2024-05 | 0 | 14.4 |
| 2024-06 | 0 | 8.86 |
| 2024-07 | 0 | 10.57 |
| 2024-08 | 0 | 9.29 |
| 2024-09 | 0 | 9 |
| 2024-10 | 2 | 6.89 |
| 2024-11 | 0 | 10.5 |
| 2024-12 | 0 | 4 |
| 2025-01 | 0 | 7.14 |
| 2025-02 | 0 | 5.17 |
| 2025-03 | 0 | 6 |
| 2025-04 | 2 | 5.75 |
| 2025-05 | 0 | 4.17 |
| 2025-06 | 0 | 8.33 |
| 2025-07 | 0 | 5 |
| 2025-08 | 0 | 5 |
| 2025-09 | 1 | 4.86 |
| 2025-10 | 0 | 7 |
| 2025-11 | 0 | 5.2 |
| 2025-12 | 2 | 4.7 |
| 2026-01 | 0 | 10.5 |
| 2026-02 | 0 | 3.33 |
| 2026-03 | 0 | 6.38 |
| 2026-04 | 0 | 4.25 |
| 2026-05 | 2 | 6.88 |
| 2026-06 | 0 | 3.63 |
Failure-mode summaryAI-generated
37 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-13 | 1016427-2026-00034 | Malfunction | Available | catalog number |
| 2025-12-05 | 1016427-2025-00091 | Malfunction | Available | catalog number |
| 2025-09-24 | 1016427-2025-00081 | Malfunction | Available | catalog number |
| 2025-04-27 | 1016427-2025-00028 | Malfunction | Available | catalog number |
| 2024-10-04 | 1016427-2024-00035 | Malfunction | Available | catalog number |
| 2023-10-27 | 1016427-2023-05570 | Malfunction | Available | catalog number |
| 2023-10-27 | 1016427-2023-05569 | Malfunction | Available | catalog number |
| 2023-10-09 | 1016427-2023-05566 | Malfunction | Available | catalog number |
| 2023-10-05 | 1016427-2023-05564 | Malfunction | Available | catalog number |
| 2023-08-25 | 1016427-2023-05562 | Injury | Available | catalog number |
| 2023-01-05 | 1016427-2023-05436 | Injury | Available | catalog number |
| 2022-03-28 | 1016427-2022-05397 | Malfunction | Available | catalog number |
| 2021-10-21 | 1016427-2021-05376 | Malfunction | Available | catalog number |
| 2020-10-12 | 1016427-2020-04446 | Malfunction | Available | catalog number |
| 2019-10-31 | 1016427-2019-03474 | Malfunction | Available | catalog number |
Showing the most recent 20 of 37 linked reports.
Showing 1–15 of 20
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-06-29 | VAI | Voluntary action indicated | Cordis US Corp | 0 |
| 2022-06-29 | VAI | Voluntary action indicated | Cordis US Corp | 0 |
| 2018-01-12 | VAI | Voluntary action indicated | Cordis US Corp | 1 |
| 2018-01-12 | VAI | Voluntary action indicated | Cordis US Corp | 1 |
| 2017-09-15 | VAI | Voluntary action indicated | AccessClosure, Inc., A Cardinal Health Company | 1 |
| 2016-07-06 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-07-06 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-03-31 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-03-31 | NAI | No action indicated | Cordis US Corp | 0 |
| 2016-02-12 | VAI | Voluntary action indicated | Cardinal Health Mexico 244 S de RL de CV | 3 |
| 2016-02-01 | NAI | No action indicated | AccessClosure, Inc., A Cardinal Health Company | 0 |
| 2015-05-08 | NAI | No action indicated | Cordis US Corp | 0 |
| 2015-05-08 | NAI | No action indicated | Cordis US Corp | 0 |
| 2014-08-05 | VAI | Voluntary action indicated | AccessClosure, Inc., A Cardinal Health Company | 3 |
| 2014-04-03 | NAI | No action indicated | Cardinal Health Mexico 244 S de RL de CV | 0 |
| 2014-01-30 | NAI | No action indicated | Cordis US Corp | 0 |
| 2014-01-30 | NAI | No action indicated | Cordis US Corp | 0 |
| 2013-12-18 | NAI | No action indicated | Cordis US Corp | 0 |
| 2013-12-18 | NAI | No action indicated | Cordis US Corp | 0 |
| 2012-07-03 | NAI | No action indicated | Cordis US Corp | 0 |
| 2011-02-16 | WL | Warning Letter | Cordis LLC | — |
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