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.
4 linked reportsMalfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.71 |
| 2019-02 | 0 | 3.25 |
| 2019-03 | 0 | 3.75 |
| 2019-04 | 0 | 3.25 |
| 2019-05 | 0 | 3.8 |
| 2019-06 | 0 | 3.33 |
| 2019-07 | 0 | 3.2 |
| 2019-08 | 0 | 2.5 |
| 2019-09 | 0 | 5.25 |
| 2019-10 | 0 | 4.1 |
| 2019-11 | 0 | 3.5 |
| 2019-12 | 0 | 3.83 |
| 2020-01 | 0 | 2.38 |
| 2020-02 | 0 | 2.86 |
| 2020-03 | 0 | 3.11 |
| 2020-04 | 0 | 3.4 |
| 2020-05 | 0 | 3 |
| 2020-06 | 0 | 4.6 |
| 2020-07 | 0 | 3.64 |
| 2020-08 | 0 | 2.33 |
| 2020-09 | 0 | 4.5 |
| 2020-10 | 0 | 3 |
| 2020-11 | 0 | 7.33 |
| 2020-12 | 0 | 3.13 |
| 2021-01 | 0 | 2.44 |
| 2021-02 | 0 | 2.56 |
| 2021-03 | 0 | 5 |
| 2021-04 | 0 | 2.88 |
| 2021-05 | 0 | 4.17 |
| 2021-06 | 0 | 2.16 |
| 2021-07 | 0 | 3 |
| 2021-08 | 0 | 1.29 |
| 2021-09 | 0 | 1.8 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 0 | 2.33 |
| 2021-12 | 0 | 2.25 |
| 2022-01 | 0 | 1.5 |
| 2022-02 | 0 | 1.75 |
| 2022-03 | 0 | 1.33 |
| 2022-04 | 0 | 1.9 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 2.17 |
| 2022-07 | 0 | 2.07 |
| 2022-08 | 0 | 1.33 |
| 2022-09 | 0 | 1.25 |
| 2022-10 | 0 | 1.71 |
| 2022-11 | 0 | 2.4 |
| 2022-12 | 0 | 1 |
| 2023-01 | 0 | 1.5 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1.22 |
| 2023-04 | 0 | 1.64 |
| 2023-05 | 0 | 1.2 |
| 2023-06 | 0 | 1.25 |
| 2023-07 | 0 | 1.73 |
| 2023-08 | 0 | 1.43 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 1.88 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 1.57 |
| 2024-01 | 0 | 1.31 |
| 2024-02 | 0 | 1.44 |
| 2024-03 | 0 | 1.6 |
| 2024-04 | 0 | 1.56 |
| 2024-05 | 0 | 1.33 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.67 |
| 2024-08 | 0 | 1.57 |
| 2024-09 | 0 | 2.09 |
| 2024-10 | 0 | 1.45 |
| 2024-11 | 0 | 1.46 |
| 2024-12 | 0 | 1.5 |
| 2025-01 | 0 | 1.53 |
| 2025-02 | 0 | 1.71 |
| 2025-03 | 0 | 1.55 |
| 2025-04 | 0 | 1.61 |
| 2025-05 | 0 | 1.82 |
| 2025-06 | 0 | 1.44 |
| 2025-07 | 0 | 1.47 |
| 2025-08 | 4 | 3.25 |
| 2025-09 | 0 | 1.33 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 1.43 |
| 2025-12 | 0 | 2.33 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1.25 |
| 2026-04 | 0 | 1.84 |
| 2026-05 | 0 | 2.71 |
| 2026-06 | 0 | 3.74 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-08-18 | Z-0027-2026 | Class II | Open, Classified | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."Distribution: US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand. | 3 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-08-19 | 9610612-2025-00174 | Malfunction | Available | catalog number |
| 2025-08-04 | 9610612-2025-00156 | Malfunction | Available | catalog number |
Showing the most recent 2 of 4 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-07-11 | NAI | No action indicated | Aesculap Inc | 0 |
| 2025-07-11 | NAI | No action indicated | Aesculap Inc | 0 |
| 2022-07-21 | NAI | No action indicated | Aesculap AG | 0 |
| 2022-07-21 | NAI | No action indicated | Aesculap AG | 0 |
| 2021-08-11 | VAI | Voluntary action indicated | Aesculap Inc | 3 |
| 2021-08-11 | VAI | Voluntary action indicated | Aesculap Inc | 3 |
| 2018-06-13 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2018-06-13 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-09-22 | NAI | No action indicated | Aesculap AG | 0 |
| 2016-09-22 | NAI | No action indicated | Aesculap AG | 0 |
| 2016-09-14 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-09-14 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-07-13 | NAI | No action indicated | Aesculap Inc | 0 |
| 2016-07-13 | NAI | No action indicated | Aesculap Inc | 0 |
| 2015-07-16 | NAI | No action indicated | Aesculap AG | 1 |
| 2015-07-16 | NAI | No action indicated | Aesculap AG | 1 |
| 2015-05-05 | NAI | No action indicated | Aesculap Inc | 0 |
| 2015-05-05 | NAI | No action indicated | Aesculap Inc | 0 |
| 2014-10-23 | NAI | No action indicated | Aesculap Inc | 0 |
| 2014-10-23 | NAI | No action indicated | Aesculap Inc | 0 |
| 2011-09-26 | WL | Warning Letter | Aesculap AG | — |
| 2011-09-26 | WL | Warning Letter | Aesculap AG | — |
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