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.
52 linked reportsInjury 24Malfunction 24Death 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 2 | 2.64 |
| 2019-02 | 3 | 3.27 |
| 2019-03 | 2 | 2.21 |
| 2019-04 | 2 | 2.4 |
| 2019-05 | 3 | 2.18 |
| 2019-06 | 5 | 3.28 |
| 2019-07 | 9 | 3.95 |
| 2019-08 | 6 | 3.9 |
| 2019-09 | 1 | 2.53 |
| 2019-10 | 2 | 3.61 |
| 2019-11 | 3 | 3.11 |
| 2019-12 | 0 | 3.55 |
| 2020-01 | 5 | 3.91 |
| 2020-02 | 1 | 5.88 |
| 2020-03 | 0 | 3.63 |
| 2020-04 | 1 | 3.42 |
| 2020-05 | 0 | 4.13 |
| 2020-06 | 0 | 3.5 |
| 2020-07 | 0 | 3.28 |
| 2020-08 | 3 | 3.71 |
| 2020-09 | 0 | 3.21 |
| 2020-10 | 0 | 3.89 |
| 2020-11 | 0 | 4.39 |
| 2020-12 | 1 | 4.48 |
| 2021-01 | 0 | 3.62 |
| 2021-02 | 0 | 3.65 |
| 2021-03 | 1 | 3 |
| 2021-04 | 0 | 3.29 |
| 2021-05 | 0 | 3.35 |
| 2021-06 | 0 | 2.53 |
| 2021-07 | 0 | 2.68 |
| 2021-08 | 0 | 3.19 |
| 2021-09 | 0 | 4 |
| 2021-10 | 0 | 4 |
| 2021-11 | 1 | 4.62 |
| 2021-12 | 0 | 4.36 |
| 2022-01 | 0 | 4.08 |
| 2022-02 | 0 | 5.7 |
| 2022-03 | 0 | 4.5 |
| 2022-04 | 0 | 2.69 |
| 2022-05 | 0 | 2.38 |
| 2022-06 | 0 | 3.81 |
| 2022-07 | 0 | 3.17 |
| 2022-08 | 0 | 1.84 |
| 2022-09 | 0 | 2.82 |
| 2022-10 | 1 | 3.67 |
| 2022-11 | 0 | 1.77 |
| 2022-12 | 0 | 3.07 |
| 2023-01 | 0 | 2.73 |
| 2023-02 | 0 | 2.82 |
| 2023-03 | 0 | 2.85 |
| 2023-04 | 0 | 2.62 |
| 2023-05 | 0 | 2.88 |
| 2023-06 | 0 | 3.52 |
| 2023-07 | 0 | 2.31 |
| 2023-08 | 0 | 3.3 |
| 2023-09 | 0 | 2.5 |
| 2023-10 | 0 | 3.17 |
| 2023-11 | 0 | 3.07 |
| 2023-12 | 0 | 2.79 |
| 2024-01 | 0 | 2.65 |
| 2024-02 | 0 | 3.08 |
| 2024-03 | 0 | 2.45 |
| 2024-04 | 0 | 3.24 |
| 2024-05 | 0 | 2.7 |
| 2024-06 | 0 | 1.73 |
| 2024-07 | 0 | 2.53 |
| 2024-08 | 0 | 3.2 |
| 2024-09 | 0 | 2.36 |
| 2024-10 | 0 | 2.81 |
| 2024-11 | 0 | 2.44 |
| 2024-12 | 0 | 2.55 |
| 2025-01 | 0 | 1.89 |
| 2025-02 | 0 | 2.82 |
| 2025-03 | 0 | 1.65 |
| 2025-04 | 0 | 3.24 |
| 2025-05 | 0 | 2 |
| 2025-06 | 0 | 2.68 |
| 2025-07 | 0 | 2.21 |
| 2025-08 | 0 | 1.5 |
| 2025-09 | 0 | 1.88 |
| 2025-10 | 0 | 2.43 |
| 2025-11 | 0 | 1.6 |
| 2025-12 | 0 | 2.35 |
| 2026-01 | 0 | 1.94 |
| 2026-02 | 0 | 2 |
| 2026-03 | 0 | 1.76 |
| 2026-04 | 0 | 4.18 |
| 2026-05 | 0 | 3.5 |
| 2026-06 | 0 | 2.58 |
Failure-mode summaryAI-generated
40 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 |
|---|---|---|---|---|
| 2022-10-21 | 3005168196-2022-00486 | Death | Available | catalog number |
| 2021-11-19 | 3005168196-2021-02647 | Malfunction | Available | catalog number |
| 2021-03-19 | 3005168196-2021-00539 | Injury | Available | catalog number |
| 2020-12-17 | 3005168196-2020-02293 | Malfunction | Available | catalog number |
| 2020-08-06 | 3005168196-2020-01108 | Malfunction | Available | catalog number |
| 2020-04-09 | 3005168196-2020-00538 | Injury | Available | catalog number |
| 2020-02-03 | 3005168196-2020-00129 | Injury | Available | catalog number |
| 2020-01-24 | 3005168196-2020-00086 | Injury | Available | catalog number |
| 2020-01-23 | 3005168196-2020-00085 | Injury | Available | catalog number |
| 2020-01-23 | 3005168196-2020-00080 | Injury | Available | catalog number |
| 2019-11-20 | 3005168196-2019-02146 | Malfunction | Available | catalog number |
| 2019-11-02 | 3005168196-2019-02037 | Injury | Available | catalog number |
| 2019-10-21 | 3005168196-2019-01970 | Injury | Available | catalog number |
| 2019-10-03 | 3005168196-2019-01865 | Injury | Available | catalog number |
| 2019-09-11 | 3005168196-2019-01727 | Malfunction | Available | catalog number |
Showing the most recent 40 of 52 linked reports.
Showing 1–15 of 40
Regulatory clearances
- 510(k)K162901Substantially equivalent (SESE) · 2017-04-20clearance 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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