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.
12 linked reportsMalfunction 10Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.49 |
| 2019-02 | 0 | 3.51 |
| 2019-03 | 0 | 2.8 |
| 2019-04 | 0 | 3.52 |
| 2019-05 | 0 | 3.68 |
| 2019-06 | 0 | 3.14 |
| 2019-07 | 0 | 3.77 |
| 2019-08 | 0 | 3.83 |
| 2019-09 | 0 | 3.28 |
| 2019-10 | 0 | 4.5 |
| 2019-11 | 0 | 3.51 |
| 2019-12 | 0 | 3.51 |
| 2020-01 | 0 | 4.57 |
| 2020-02 | 0 | 3.84 |
| 2020-03 | 0 | 3.56 |
| 2020-04 | 0 | 3.89 |
| 2020-05 | 0 | 4.29 |
| 2020-06 | 0 | 4.44 |
| 2020-07 | 0 | 5.25 |
| 2020-08 | 0 | 4.21 |
| 2020-09 | 0 | 3.98 |
| 2020-10 | 0 | 2.69 |
| 2020-11 | 0 | 2.28 |
| 2020-12 | 0 | 2.04 |
| 2021-01 | 0 | 2.4 |
| 2021-02 | 0 | 2.41 |
| 2021-03 | 0 | 2.88 |
| 2021-04 | 0 | 2.61 |
| 2021-05 | 0 | 2.26 |
| 2021-06 | 0 | 2.3 |
| 2021-07 | 0 | 2.76 |
| 2021-08 | 0 | 2.69 |
| 2021-09 | 0 | 3.36 |
| 2021-10 | 0 | 3.12 |
| 2021-11 | 0 | 4.02 |
| 2021-12 | 0 | 3.19 |
| 2022-01 | 0 | 2.36 |
| 2022-02 | 0 | 3.05 |
| 2022-03 | 0 | 3.41 |
| 2022-04 | 0 | 3.03 |
| 2022-05 | 0 | 2.75 |
| 2022-06 | 0 | 3 |
| 2022-07 | 0 | 4.86 |
| 2022-08 | 0 | 2.91 |
| 2022-09 | 0 | 3.08 |
| 2022-10 | 0 | 1.97 |
| 2022-11 | 0 | 2.77 |
| 2022-12 | 0 | 2.6 |
| 2023-01 | 0 | 3.35 |
| 2023-02 | 0 | 2.59 |
| 2023-03 | 0 | 2.22 |
| 2023-04 | 0 | 2.41 |
| 2023-05 | 0 | 2.87 |
| 2023-06 | 0 | 2.46 |
| 2023-07 | 0 | 2.95 |
| 2023-08 | 0 | 2.82 |
| 2023-09 | 0 | 2.85 |
| 2023-10 | 0 | 2.53 |
| 2023-11 | 0 | 2.11 |
| 2023-12 | 0 | 2.37 |
| 2024-01 | 0 | 2.63 |
| 2024-02 | 0 | 2.52 |
| 2024-03 | 0 | 2.32 |
| 2024-04 | 0 | 2.75 |
| 2024-05 | 1 | 2.68 |
| 2024-06 | 1 | 2.95 |
| 2024-07 | 0 | 2.41 |
| 2024-08 | 1 | 2.49 |
| 2024-09 | 0 | 2 |
| 2024-10 | 0 | 2.46 |
| 2024-11 | 0 | 2.71 |
| 2024-12 | 0 | 2.1 |
| 2025-01 | 0 | 2.58 |
| 2025-02 | 0 | 2.14 |
| 2025-03 | 0 | 2.41 |
| 2025-04 | 0 | 1.73 |
| 2025-05 | 1 | 2.26 |
| 2025-06 | 0 | 2.08 |
| 2025-07 | 2 | 2.89 |
| 2025-08 | 0 | 2.48 |
| 2025-09 | 1 | 2.69 |
| 2025-10 | 1 | 2.46 |
| 2025-11 | 2 | 2.68 |
| 2025-12 | 2 | 2.61 |
| 2026-01 | 0 | 2.82 |
| 2026-02 | 0 | 2.75 |
| 2026-03 | 0 | 2.19 |
| 2026-04 | 0 | 2.99 |
| 2026-05 | 0 | 2.46 |
| 2026-06 | 0 | 2.96 |
Failure-mode summaryAI-generated
12 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-30 | 9680794-2025-01069 | Malfunction | Available | exact di |
| 2025-12-30 | 9680794-2025-01070 | Malfunction | Available | exact di |
| 2025-11-19 | 9680794-2025-00971 | Injury | Available | exact di |
| 2025-11-19 | 9680794-2025-00970 | Injury | Available | exact di |
| 2025-10-28 | 9680794-2025-00897 | Malfunction | Available | exact di |
| 2025-09-19 | 9680794-2025-00782 | Malfunction | Available | exact di |
| 2025-07-31 | 9680794-2025-00640 | Malfunction | Available | exact di |
| 2025-07-09 | 9680794-2025-00593 | Malfunction | Available | exact di |
| 2025-05-07 | 9680794-2025-00387 | Malfunction | Available | exact di |
| 2024-08-28 | 9680794-2024-00810 | Malfunction | Available | exact di |
| 2024-06-25 | 9680794-2024-00606 | Malfunction | Available | exact di |
| 2024-05-01 | 9680794-2024-00331 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K123759Substantially equivalent (SESE) · 2013-01-03clearance family
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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