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.
2 linked reportsMalfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.61 |
| 2019-02 | 0 | 2.09 |
| 2019-03 | 0 | 1.88 |
| 2019-04 | 0 | 2.37 |
| 2019-05 | 0 | 1.84 |
| 2019-06 | 0 | 2.09 |
| 2019-07 | 0 | 2.66 |
| 2019-08 | 2 | 2.26 |
| 2019-09 | 0 | 1.79 |
| 2019-10 | 0 | 2.8 |
| 2019-11 | 0 | 2.11 |
| 2019-12 | 0 | 2.24 |
| 2020-01 | 0 | 2.98 |
| 2020-02 | 0 | 2.51 |
| 2020-03 | 0 | 2.36 |
| 2020-04 | 0 | 2.7 |
| 2020-05 | 0 | 2.4 |
| 2020-06 | 0 | 2.44 |
| 2020-07 | 0 | 3.17 |
| 2020-08 | 0 | 2.44 |
| 2020-09 | 0 | 2.46 |
| 2020-10 | 0 | 3.19 |
| 2020-11 | 0 | 2.57 |
| 2020-12 | 0 | 2.83 |
| 2021-01 | 0 | 2.7 |
| 2021-02 | 0 | 2.66 |
| 2021-03 | 0 | 2.47 |
| 2021-04 | 0 | 2.32 |
| 2021-05 | 0 | 2.83 |
| 2021-06 | 0 | 2.46 |
| 2021-07 | 0 | 2.26 |
| 2021-08 | 0 | 2.57 |
| 2021-09 | 0 | 2.39 |
| 2021-10 | 0 | 2.48 |
| 2021-11 | 0 | 2.39 |
| 2021-12 | 0 | 2.48 |
| 2022-01 | 0 | 2.36 |
| 2022-02 | 0 | 2.44 |
| 2022-03 | 0 | 2.2 |
| 2022-04 | 0 | 2.3 |
| 2022-05 | 0 | 1.91 |
| 2022-06 | 0 | 2.42 |
| 2022-07 | 0 | 2.15 |
| 2022-08 | 0 | 2.29 |
| 2022-09 | 0 | 2.28 |
| 2022-10 | 0 | 2.41 |
| 2022-11 | 0 | 2.04 |
| 2022-12 | 0 | 2.04 |
| 2023-01 | 0 | 1.91 |
| 2023-02 | 0 | 2.11 |
| 2023-03 | 0 | 2.11 |
| 2023-04 | 0 | 2.22 |
| 2023-05 | 0 | 2.01 |
| 2023-06 | 0 | 2.34 |
| 2023-07 | 0 | 2.08 |
| 2023-08 | 0 | 2.06 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 2.37 |
| 2023-11 | 0 | 2.52 |
| 2023-12 | 0 | 2.48 |
| 2024-01 | 0 | 1.93 |
| 2024-02 | 0 | 2.14 |
| 2024-03 | 0 | 1.91 |
| 2024-04 | 0 | 2.09 |
| 2024-05 | 0 | 2.04 |
| 2024-06 | 0 | 2.04 |
| 2024-07 | 0 | 2.08 |
| 2024-08 | 0 | 2.14 |
| 2024-09 | 0 | 2.1 |
| 2024-10 | 0 | 2.35 |
| 2024-11 | 0 | 2.42 |
| 2024-12 | 0 | 2.91 |
| 2025-01 | 0 | 2.75 |
| 2025-02 | 0 | 2.86 |
| 2025-03 | 0 | 2.53 |
| 2025-04 | 0 | 2.57 |
| 2025-05 | 0 | 2.57 |
| 2025-06 | 0 | 3.15 |
| 2025-07 | 0 | 3.09 |
| 2025-08 | 0 | 2.53 |
| 2025-09 | 0 | 2.77 |
| 2025-10 | 0 | 3.2 |
| 2025-11 | 0 | 2.99 |
| 2025-12 | 0 | 3.65 |
| 2026-01 | 0 | 3.28 |
| 2026-02 | 0 | 3.16 |
| 2026-03 | 0 | 3.1 |
| 2026-04 | 0 | 3.14 |
| 2026-05 | 0 | 3.42 |
| 2026-06 | 0 | 3.31 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2017-06-09 | Z-2702-2017 | Class I | Terminated | Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.Distribution: Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV | 155 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2019-08-22 | 3005168196-2019-01611 | Malfunction | Available | catalog number |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
- 510(k)K162901Substantially equivalent (SESE) · 2017-04-20clearance family
- 510(k)K160449Substantially equivalent (SESE) · 2016-05-25clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2021-06-21 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2021-06-21 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2017-02-13 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2017-02-13 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2016-02-23 | VAI | Voluntary action indicated | Penumbra Inc. | 0 |
| 2016-02-23 | VAI | Voluntary action indicated | Penumbra Inc. | 0 |
| 2015-08-04 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2015-08-04 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2015-07-15 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2015-07-15 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2014-04-30 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2014-04-30 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2012-02-27 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2012-02-27 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2010-08-24 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2010-08-24 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2009-12-31 | WL | Warning Letter | Penumbra Inc. | — |
| 2009-12-31 | WL | Warning Letter | Penumbra Inc. | — |
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