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.
72 linked reportsMalfunction 61Injury 11
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 1.5 |
| 2019-02 | 1 | 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 | 2 | 2.83 |
| 2019-10 | 2 | 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 | 3 | 2.2 |
| 2020-07 | 0 | 4.5 |
| 2020-08 | 0 | 3 |
| 2020-09 | 0 | 3.25 |
| 2020-10 | 0 | 3 |
| 2020-11 | 0 | 2.44 |
| 2020-12 | 0 | 3 |
| 2021-01 | 0 | 3 |
| 2021-02 | 3 | 5 |
| 2021-03 | 3 | 4.33 |
| 2021-04 | 0 | 3.14 |
| 2021-05 | 3 | 2.6 |
| 2021-06 | 3 | 3.6 |
| 2021-07 | 6 | 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 | 6 | 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 | 6 | 3.67 |
| 2022-09 | 3 | 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 | 0 | 4 |
| 2023-05 | 0 | 2.29 |
| 2023-06 | 0 | 2.75 |
| 2023-07 | 0 | 2.29 |
| 2023-08 | 0 | 2.6 |
| 2023-09 | 0 | 2.29 |
| 2023-10 | 0 | 4.25 |
| 2023-11 | 0 | 4.4 |
| 2023-12 | 2 | 2.25 |
| 2024-01 | 0 | 1.33 |
| 2024-02 | 0 | 3 |
| 2024-03 | 0 | 2.75 |
| 2024-04 | 0 | 3.5 |
| 2024-05 | 3 | 3.42 |
| 2024-06 | 0 | 3.4 |
| 2024-07 | 0 | 2.5 |
| 2024-08 | 0 | 3 |
| 2024-09 | 0 | 2.75 |
| 2024-10 | 0 | 1.67 |
| 2024-11 | 5 | 4.27 |
| 2024-12 | 0 | 2.33 |
| 2025-01 | 0 | 2.08 |
| 2025-02 | 0 | 2.5 |
| 2025-03 | 0 | 2.22 |
| 2025-04 | 2 | 3.25 |
| 2025-05 | 0 | 3.13 |
| 2025-06 | 0 | 3.56 |
| 2025-07 | 0 | 4.21 |
| 2025-08 | 0 | 3.5 |
| 2025-09 | 0 | 3.54 |
| 2025-10 | 3 | 2.84 |
| 2025-11 | 0 | 2.89 |
| 2025-12 | 0 | 2.18 |
| 2026-01 | 0 | 3.68 |
| 2026-02 | 3 | 4 |
| 2026-03 | 0 | 2.53 |
| 2026-04 | 0 | 2.88 |
| 2026-05 | 6 | 2.84 |
| 2026-06 | 3 | 5.37 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-03 | 2024168-2026-02240 | Malfunction | Available | catalog number |
| 2026-05-05 | 2024168-2026-01802 | Malfunction | Available | catalog number |
| 2026-05-05 | 2024168-2026-01817 | Malfunction | Available | catalog number |
| 2026-02-20 | 2024168-2026-00721 | Malfunction | Available | catalog number |
| 2025-10-15 | 2024168-2025-11096 | Malfunction | Available | catalog number |
| 2025-04-07 | 2024168-2025-03542 | Malfunction | Available | catalog number |
| 2024-11-20 | 2024168-2024-13727 | Malfunction | Available | catalog number |
| 2024-11-14 | 2024168-2024-13447 | Injury | Available | catalog number |
| 2024-05-24 | 2024168-2024-06264 | Malfunction | Available | catalog number |
| 2023-12-04 | 2024168-2023-13413 | Malfunction | Available | catalog number |
| 2022-09-15 | 2024168-2022-09787 | Malfunction | Available | catalog number |
| 2022-08-16 | 2024168-2022-08810 | Malfunction | Available | catalog number |
| 2022-08-08 | 2024168-2022-08613 | Malfunction | Available | catalog number |
| 2022-06-03 | 2024168-2022-05952 | Malfunction | Available | catalog number |
| 2022-02-17 | 2024168-2022-01685 | Malfunction | Available | catalog number |
Showing the most recent 27 of 72 linked reports.
Showing 1–15 of 27
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-12-08 | NAI | No action indicated | Abbott Vascular | 0 |
| 2023-11-16 | OAI | Official action indicated | Abbott Vascular | 0 |
| 2023-10-27 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2022-08-23 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2021-11-03 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2019-10-24 | NAI | No action indicated | Abbott Vascular | 0 |
| 2017-11-15 | VAI | Voluntary action indicated | Abbott Vascular | 2 |
| 2017-10-10 | NAI | No action indicated | Abbott Vascular | 0 |
| 2017-10-04 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2016-12-09 | NAI | No action indicated | Abbott Vascular | 0 |
| 2016-04-15 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2015-12-10 | NAI | No action indicated | Abbott Vascular | 0 |
| 2015-09-11 | NAI | No action indicated | Abbott Vascular | 0 |
| 2015-08-14 | NAI | No action indicated | Abbott Vascular, Inc. | 0 |
| 2015-07-23 | NAI | No action indicated | Abbott Vascular | 0 |
| 2014-11-24 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2014-08-21 | NAI | No action indicated | Abbott Vascular | 0 |
| 2014-03-14 | NAI | No action indicated | Abbott Vascular | 0 |
| 2014-02-19 | NAI | No action indicated | Abbott Vascular | 0 |
| 2014-02-11 | VAI | Voluntary action indicated | Abbott Vascular Inc | 3 |
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