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.
83 linked reportsMalfunction 78Injury 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 3 | 2.61 |
| 2019-02 | 1 | 1.91 |
| 2019-03 | 2 | 1.82 |
| 2019-04 | 3 | 2.36 |
| 2019-05 | 1 | 1.75 |
| 2019-06 | 4 | 1.88 |
| 2019-07 | 1 | 2.51 |
| 2019-08 | 0 | 1.98 |
| 2019-09 | 0 | 1.7 |
| 2019-10 | 0 | 2.7 |
| 2019-11 | 0 | 1.95 |
| 2019-12 | 2 | 2.02 |
| 2020-01 | 0 | 2.84 |
| 2020-02 | 0 | 2.03 |
| 2020-03 | 1 | 2.19 |
| 2020-04 | 2 | 2.62 |
| 2020-05 | 1 | 2 |
| 2020-06 | 1 | 2.3 |
| 2020-07 | 2 | 3.16 |
| 2020-08 | 1 | 2.25 |
| 2020-09 | 3 | 2.27 |
| 2020-10 | 0 | 3.12 |
| 2020-11 | 4 | 2.26 |
| 2020-12 | 2 | 2.59 |
| 2021-01 | 2 | 2.54 |
| 2021-02 | 1 | 2.54 |
| 2021-03 | 0 | 2.38 |
| 2021-04 | 4 | 2.24 |
| 2021-05 | 0 | 2.74 |
| 2021-06 | 1 | 2.46 |
| 2021-07 | 3 | 2.21 |
| 2021-08 | 0 | 2.49 |
| 2021-09 | 3 | 2.25 |
| 2021-10 | 0 | 2.36 |
| 2021-11 | 1 | 2.08 |
| 2021-12 | 1 | 2.26 |
| 2022-01 | 0 | 2.18 |
| 2022-02 | 3 | 2.17 |
| 2022-03 | 2 | 1.97 |
| 2022-04 | 1 | 2.25 |
| 2022-05 | 2 | 1.86 |
| 2022-06 | 1 | 2.22 |
| 2022-07 | 6 | 2.06 |
| 2022-08 | 1 | 2.37 |
| 2022-09 | 1 | 2.18 |
| 2022-10 | 1 | 2.2 |
| 2022-11 | 0 | 2.06 |
| 2022-12 | 2 | 1.92 |
| 2023-01 | 0 | 1.8 |
| 2023-02 | 0 | 1.96 |
| 2023-03 | 0 | 2.01 |
| 2023-04 | 0 | 2.13 |
| 2023-05 | 1 | 1.85 |
| 2023-06 | 0 | 2.11 |
| 2023-07 | 1 | 2.05 |
| 2023-08 | 1 | 1.85 |
| 2023-09 | 0 | 1.92 |
| 2023-10 | 0 | 2.21 |
| 2023-11 | 0 | 2.39 |
| 2023-12 | 0 | 2.42 |
| 2024-01 | 2 | 1.77 |
| 2024-02 | 0 | 1.96 |
| 2024-03 | 0 | 1.83 |
| 2024-04 | 0 | 1.92 |
| 2024-05 | 0 | 1.94 |
| 2024-06 | 0 | 2.12 |
| 2024-07 | 1 | 1.99 |
| 2024-08 | 0 | 1.97 |
| 2024-09 | 0 | 2.07 |
| 2024-10 | 0 | 2.28 |
| 2024-11 | 2 | 2.41 |
| 2024-12 | 0 | 2.97 |
| 2025-01 | 2 | 2.91 |
| 2025-02 | 0 | 2.87 |
| 2025-03 | 1 | 2.68 |
| 2025-04 | 1 | 2.49 |
| 2025-05 | 0 | 2.66 |
| 2025-06 | 0 | 3.23 |
| 2025-07 | 0 | 3.2 |
| 2025-08 | 0 | 2.73 |
| 2025-09 | 0 | 2.88 |
| 2025-10 | 0 | 3.24 |
| 2025-11 | 1 | 3.19 |
| 2025-12 | 0 | 3.84 |
| 2026-01 | 0 | 3.49 |
| 2026-02 | 0 | 3.34 |
| 2026-03 | 0 | 3.29 |
| 2026-04 | 0 | 3.06 |
| 2026-05 | 0 | 3.41 |
| 2026-06 | 0 | 3.38 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-04-23 | Z-1907-2024 | Class II | Open, Classified | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom. | 2579 | code info di |
| 2018-04-11 | Z-2569-2018 | Class II | Terminated | There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device would be used, which could potentially prolong a procedure.Distribution: Nationwide | 968 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-11-24 | 3012931345-2025-00185 | Malfunction | Available | exact di |
| 2025-04-09 | 3012931345-2025-00072 | Malfunction | Available | exact di |
| 2025-03-27 | 3012931345-2025-00068 | Injury | Available | exact di |
| 2025-01-10 | 3012931345-2025-00006 | Malfunction | Available | exact di |
| 2025-01-09 | 3012931345-2025-00004 | Malfunction | Available | exact di |
| 2024-11-19 | 3012931345-2024-00202 | Malfunction | Available | exact di |
| 2024-11-12 | 3012931345-2024-00198 | Malfunction | Available | exact di |
| 2024-07-12 | 3012931345-2024-00122 | Malfunction | Available | exact di |
| 2024-01-23 | 3012931345-2024-00013 | Malfunction | Available | exact di |
| 2024-01-23 | 3012931345-2024-00014 | Malfunction | Available | exact di |
| 2023-08-14 | 3012931345-2023-00190 | Malfunction | Available | exact di |
| 2023-07-14 | 3012931345-2023-00160 | Malfunction | Available | exact di |
| 2023-05-19 | 3012931345-2023-00092 | Malfunction | Available | exact di |
| 2022-12-21 | 3012931345-2022-00229 | Malfunction | Available | exact di |
| 2022-12-14 | 3012931345-2022-00223 | Malfunction | Available | exact di |
Showing 1–15 of 83
Regulatory clearances
- 510(k)K153729Substantially equivalent (SESE) · 2016-01-27clearance 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 |
|---|---|---|---|---|
| 2026-06-18 | NAI | No action indicated | International Life Sciences | 0 |
| 2026-02-20 | VAI | Voluntary action indicated | Stryker Puerto Rico, LLC | 2 |
| 2025-12-11 | NAI | No action indicated | Stryker Manufacturing Kalamazoo | 0 |
| 2025-05-22 | NAI | No action indicated | Stryker Macroom | 0 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-02-27 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
| 2025-01-30 | NAI | No action indicated | Serf | 0 |
| 2024-12-18 | VAI | Voluntary action indicated | Stryker Neurovascular | 1 |
| 2024-11-15 | VAI | Voluntary action indicated | Stryker Medical Division of Stryker Corporation | 2 |
| 2024-11-13 | NAI | No action indicated | POM Medical LLC | 0 |
| 2024-07-25 | VAI | Voluntary action indicated | Stryker Ireland, Ltd., Instruments Division | 1 |
| 2024-05-03 | NAI | No action indicated | Stryker Neurovascular, Inc. | 0 |
| 2024-04-18 | NAI | No action indicated | Physio-Control, Inc. | 0 |
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2023-05-15 | VAI | Voluntary action indicated | LimFlow, Inc. | 2 |
| 2023-04-25 | NAI | No action indicated | Stryker Puerto Rico, LLC | 0 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | POM Medical LLC | 0 |
| 2017-04-06 | WL | Warning Letter | Entellus Medical Inc. | — |
| 2015-04-08 | WL | Warning Letter | Thermedx LLC | — |
| 2013-11-26 | INJ | Injunction | Physio-Control, Inc. | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
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