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.
96 linked reportsMalfunction 95Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-04 | 0 | 1.5 |
| 2019-05 | 0 | 1.5 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1.4 |
| 2019-10 | 0 | 1.5 |
| 2019-11 | 0 | 2 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1.17 |
| 2020-04 | 0 | 1 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 1 |
| 2020-11 | 0 | 2 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 1.29 |
| 2021-02 | 4 | 2.17 |
| 2021-03 | 0 | 1.17 |
| 2021-04 | 1 | 1 |
| 2021-05 | 10 | 2.8 |
| 2021-06 | 0 | 2.5 |
| 2021-07 | 1 | 1.5 |
| 2021-08 | 2 | 1.75 |
| 2021-09 | 3 | 4.2 |
| 2021-10 | 7 | 2.5 |
| 2021-11 | 11 | 3.14 |
| 2021-12 | 3 | 2.57 |
| 2022-01 | 0 | 1.5 |
| 2022-02 | 1 | 1.17 |
| 2022-03 | 0 | 2.29 |
| 2022-04 | 4 | 3.5 |
| 2022-05 | 0 | 3.5 |
| 2022-06 | 1 | 1.83 |
| 2022-07 | 0 | 2 |
| 2022-08 | 7 | 3.8 |
| 2022-09 | 0 | 2.13 |
| 2022-10 | 1 | 1.43 |
| 2022-11 | 0 | 1.5 |
| 2022-12 | 0 | 1 |
| 2023-01 | 0 | 2.67 |
| 2023-02 | 1 | 1 |
| 2023-03 | 6 | 5 |
| 2023-04 | 0 | 1.67 |
| 2023-05 | 0 | 2 |
| 2023-06 | 1 | 2 |
| 2023-07 | 2 | 1.2 |
| 2023-08 | 0 | 2.33 |
| 2023-09 | 1 | 1.4 |
| 2023-10 | 0 | 1.22 |
| 2023-11 | 8 | 5.67 |
| 2023-12 | 0 | 2 |
| 2024-01 | 2 | 1.6 |
| 2024-02 | 0 | 1.33 |
| 2024-03 | 0 | 1.25 |
| 2024-04 | 2 | 1.44 |
| 2024-05 | 0 | 1.6 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 2.43 |
| 2024-09 | 2 | 1.22 |
| 2024-10 | 2 | 2.13 |
| 2024-11 | 1 | 1.77 |
| 2024-12 | 1 | 4.75 |
| 2025-01 | 0 | 1.5 |
| 2025-02 | 0 | 1.67 |
| 2025-03 | 0 | 7 |
| 2025-04 | 2 | 5.4 |
| 2025-05 | 2 | 1.4 |
| 2025-06 | 3 | 2.86 |
| 2025-07 | 2 | 3.38 |
| 2025-08 | 0 | 1 |
| 2025-09 | 0 | 1.33 |
| 2025-10 | 1 | 1.67 |
| 2025-11 | 1 | 1.56 |
| 2025-12 | 0 | 2.29 |
| 2026-01 | 0 | 3 |
| 2026-02 | 0 | 5.25 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1 |
| 2026-05 | 0 | 3 |
| 2026-06 | 0 | 3 |
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 |
|---|---|---|---|---|
| 2025-11-05 | 3003898360-2025-00810 | Malfunction | Available | exact di |
| 2025-10-24 | 3003898360-2025-00782 | Malfunction | Available | exact di |
| 2025-07-07 | 3003898360-2025-00504 | Malfunction | Available | exact di |
| 2025-07-07 | 3003898360-2025-00505 | Malfunction | Available | exact di |
| 2025-06-10 | 3003898360-2025-00455 | Malfunction | Available | exact di |
| 2025-06-10 | 3003898360-2025-00456 | Malfunction | Available | exact di |
| 2025-06-06 | 3003898360-2025-00453 | Malfunction | Available | exact di |
| 2025-05-12 | 3003898360-2025-00386 | Malfunction | Available | exact di |
| 2025-05-12 | 3003898360-2025-00387 | Injury | Available | exact di |
| 2025-04-18 | 3003898360-2025-00322 | Malfunction | Available | exact di |
| 2025-04-03 | 3003898360-2025-00287 | Malfunction | Available | exact di |
| 2024-12-31 | 3003898360-2024-01624 | Malfunction | Available | exact di |
| 2024-11-29 | 3003898360-2024-01507 | Malfunction | Available | exact di |
| 2024-10-29 | 3003898360-2024-01377 | Malfunction | Available | exact di |
| 2024-10-16 | 3003898360-2024-01362 | Malfunction | Available | exact di |
Showing the most recent 95 of 96 linked reports.
Showing 1–15 of 95
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-01-15 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2024-03-18 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2024-03-18 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2024-01-26 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2022-12-09 | NAI | No action indicated | Teleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company) | 0 |
| 2022-08-26 | VAI | Voluntary action indicated | TELEFLEX LLC | 3 |
| 2022-08-26 | VAI | Voluntary action indicated | TELEFLEX LLC | 3 |
| 2021-09-02 | NAI | No action indicated | TELEFLEX LLC | 0 |
| 2021-09-02 | NAI | No action indicated | TELEFLEX LLC | 0 |
| 2021-07-30 | VAI | Voluntary action indicated | Teleflex LLC (NADC) | 4 |
| 2017-09-21 | NAI | No action indicated | Teleflex LLC | 0 |
| 2017-09-20 | VAI | Voluntary action indicated | Teleflex Medical, Inc. | 1 |
| 2017-02-02 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2016-08-29 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2016-03-03 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2016-03-03 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2015-08-13 | NAI | No action indicated | Teleflex Medical Sdn. Bhd. | 0 |
| 2015-06-05 | NAI | No action indicated | Teleflex Medical Europe Ltd | 0 |
| 2015-02-25 | NAI | No action indicated | Teleflex Medical Europe, Ltd. | 0 |
| 2014-08-28 | NAI | No action indicated | TELEFLEX LLC | 0 |
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