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.
71 linked reportsMalfunction 52Injury 13Death 6
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.64 |
| 2019-02 | 0 | 3.27 |
| 2019-03 | 0 | 2.21 |
| 2019-04 | 0 | 2.4 |
| 2019-05 | 0 | 2.18 |
| 2019-06 | 0 | 3.28 |
| 2019-07 | 0 | 3.95 |
| 2019-08 | 0 | 3.9 |
| 2019-09 | 0 | 2.53 |
| 2019-10 | 0 | 3.61 |
| 2019-11 | 0 | 3.11 |
| 2019-12 | 0 | 3.55 |
| 2020-01 | 0 | 3.91 |
| 2020-02 | 0 | 5.88 |
| 2020-03 | 0 | 3.63 |
| 2020-04 | 0 | 3.42 |
| 2020-05 | 0 | 4.13 |
| 2020-06 | 0 | 3.5 |
| 2020-07 | 0 | 3.28 |
| 2020-08 | 0 | 3.71 |
| 2020-09 | 0 | 3.21 |
| 2020-10 | 0 | 3.89 |
| 2020-11 | 0 | 4.39 |
| 2020-12 | 0 | 4.48 |
| 2021-01 | 0 | 3.62 |
| 2021-02 | 0 | 3.65 |
| 2021-03 | 0 | 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 | 0 | 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 | 0 | 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 | 2 | 2.31 |
| 2023-08 | 6 | 3.3 |
| 2023-09 | 5 | 2.5 |
| 2023-10 | 7 | 3.17 |
| 2023-11 | 4 | 3.07 |
| 2023-12 | 2 | 2.79 |
| 2024-01 | 2 | 2.65 |
| 2024-02 | 2 | 3.08 |
| 2024-03 | 4 | 2.45 |
| 2024-04 | 0 | 3.24 |
| 2024-05 | 1 | 2.7 |
| 2024-06 | 2 | 1.73 |
| 2024-07 | 0 | 2.53 |
| 2024-08 | 0 | 3.2 |
| 2024-09 | 4 | 2.36 |
| 2024-10 | 8 | 2.81 |
| 2024-11 | 2 | 2.44 |
| 2024-12 | 2 | 2.55 |
| 2025-01 | 0 | 1.89 |
| 2025-02 | 5 | 2.82 |
| 2025-03 | 2 | 1.65 |
| 2025-04 | 1 | 3.24 |
| 2025-05 | 0 | 2 |
| 2025-06 | 1 | 2.68 |
| 2025-07 | 0 | 2.21 |
| 2025-08 | 1 | 1.5 |
| 2025-09 | 0 | 1.88 |
| 2025-10 | 0 | 2.43 |
| 2025-11 | 1 | 1.6 |
| 2025-12 | 2 | 2.35 |
| 2026-01 | 1 | 1.94 |
| 2026-02 | 0 | 2 |
| 2026-03 | 1 | 1.76 |
| 2026-04 | 1 | 4.18 |
| 2026-05 | 0 | 3.5 |
| 2026-06 | 2 | 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 |
|---|---|---|---|---|---|---|
| 2020-12-15 | Z-0848-2021 | Class I | Terminated | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.Distribution: Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam. | 3,368 catheters | clearance family |
| 2020-12-15 | Z-0849-2021 | Class I | Terminated | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.Distribution: Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam. | 27,499 catheters | clearance family |
| 2020-12-15 | Z-0850-2021 | Class I | Terminated | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.Distribution: Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam. | 0 catheters | clearance family |
| 2020-12-15 | Z-0851-2021 | Class I | Terminated | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.Distribution: Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam. | 15 catheters | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-24 | 3005168196-2026-00214 | Malfunction | — | catalog number |
| 2026-06-24 | 3005168196-2026-00212 | Malfunction | — | catalog number |
| 2026-04-24 | 3005168196-2026-00147 | Injury | Available | catalog number |
| 2026-03-17 | 3005168196-2026-00084 | Malfunction | Available | catalog number |
| 2026-01-09 | 3005168196-2026-00010 | Malfunction | Available | catalog number |
| 2025-12-18 | 3005168196-2025-00406 | Malfunction | Available | catalog number |
| 2025-11-21 | 3005168196-2025-00373 | Injury | Available | catalog number |
| 2025-08-07 | 3005168196-2025-00256 | Malfunction | Available | catalog number |
| 2025-06-17 | 3005168196-2025-00205 | Malfunction | Available | catalog number |
| 2025-04-11 | 3005168196-2025-00118 | Malfunction | Available | catalog number |
| 2025-03-10 | 3005168196-2025-00072 | Malfunction | Available | catalog number |
| 2025-02-21 | 3005168196-2025-00047 | Malfunction | Available | catalog number |
| 2025-02-21 | 3005168196-2025-00052 | Malfunction | Available | catalog number |
| 2025-02-06 | 3005168196-2025-00032 | Malfunction | Available | catalog number |
| 2024-12-27 | 3005168196-2024-00428 | Malfunction | Available | catalog number |
Showing the most recent 42 of 71 linked reports.
Showing 1–15 of 42
Regulatory clearances
- 510(k)K211654Substantially equivalent (SESE) · 2021-08-16clearance family
- 510(k)K191946Substantially equivalent (SESE) · 2020-02-27clearance family
Predicate lineage
- K191946
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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