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.
5 linked reportsMalfunction 4Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.5 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.75 |
| 2019-04 | 0 | 3 |
| 2019-05 | 0 | 2.67 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 2.88 |
| 2019-08 | 0 | 2.25 |
| 2019-09 | 0 | 2.83 |
| 2019-10 | 0 | 2 |
| 2019-11 | 0 | 2.67 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 3.25 |
| 2020-02 | 0 | 3.5 |
| 2020-03 | 0 | 2.67 |
| 2020-04 | 0 | 2.25 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 2.2 |
| 2020-07 | 0 | 4.5 |
| 2020-08 | 0 | 3 |
| 2020-09 | 0 | 3.25 |
| 2020-10 | 0 | 3 |
| 2020-11 | 0 | 2.44 |
| 2020-12 | 0 | 3 |
| 2021-01 | 0 | 3 |
| 2021-02 | 0 | 5 |
| 2021-03 | 0 | 4.33 |
| 2021-04 | 0 | 3.14 |
| 2021-05 | 0 | 2.6 |
| 2021-06 | 0 | 3.6 |
| 2021-07 | 0 | 4 |
| 2021-08 | 0 | 2.6 |
| 2021-09 | 0 | 2.5 |
| 2021-10 | 0 | 4 |
| 2021-11 | 0 | 3 |
| 2021-12 | 0 | 2.2 |
| 2022-01 | 0 | 3 |
| 2022-02 | 0 | 2.82 |
| 2022-03 | 0 | 6 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 3.5 |
| 2022-06 | 0 | 2.78 |
| 2022-07 | 0 | 3.17 |
| 2022-08 | 0 | 3.67 |
| 2022-09 | 0 | 3.8 |
| 2022-10 | 0 | 2.67 |
| 2022-11 | 0 | 3.2 |
| 2022-12 | 0 | 3 |
| 2023-01 | 0 | 4 |
| 2023-02 | 0 | 2.6 |
| 2023-03 | 0 | 2.6 |
| 2023-04 | 0 | 4 |
| 2023-05 | 0 | 2.29 |
| 2023-06 | 0 | 2.75 |
| 2023-07 | 0 | 2.29 |
| 2023-08 | 0 | 2.6 |
| 2023-09 | 0 | 2.29 |
| 2023-10 | 0 | 4.25 |
| 2023-11 | 0 | 4.4 |
| 2023-12 | 0 | 2.25 |
| 2024-01 | 0 | 1.33 |
| 2024-02 | 0 | 3 |
| 2024-03 | 0 | 2.75 |
| 2024-04 | 0 | 3.5 |
| 2024-05 | 0 | 3.42 |
| 2024-06 | 0 | 3.4 |
| 2024-07 | 0 | 2.5 |
| 2024-08 | 0 | 3 |
| 2024-09 | 0 | 2.75 |
| 2024-10 | 0 | 1.67 |
| 2024-11 | 0 | 4.27 |
| 2024-12 | 0 | 2.33 |
| 2025-01 | 0 | 2.08 |
| 2025-02 | 0 | 2.5 |
| 2025-03 | 0 | 2.22 |
| 2025-04 | 0 | 3.25 |
| 2025-05 | 0 | 3.13 |
| 2025-06 | 0 | 3.56 |
| 2025-07 | 0 | 4.21 |
| 2025-08 | 0 | 3.5 |
| 2025-09 | 0 | 3.54 |
| 2025-10 | 0 | 2.84 |
| 2025-11 | 1 | 2.89 |
| 2025-12 | 2 | 2.18 |
| 2026-01 | 0 | 3.68 |
| 2026-02 | 0 | 4 |
| 2026-03 | 0 | 2.53 |
| 2026-04 | 0 | 2.88 |
| 2026-05 | 2 | 2.84 |
| 2026-06 | 0 | 5.37 |
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-05-01 | Z-2325-2026 | Class II | Open, Classified | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV. | 190 units | clearance family |
| 2026-05-01 | Z-2326-2026 | Class II | Open, Classified | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV. | 424 units | clearance family |
| 2026-05-01 | Z-2327-2026 | Class II | Open, Classified | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV. | 147 units | clearance family |
| 2026-05-01 | Z-2328-2026 | Class II | Open, Classified | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV. | 291 units | clearance family |
| 2026-05-01 | Z-2329-2026 | Class II | Open, Classified | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV. | 114 units | clearance family |
| 2026-05-01 | Z-2330-2026 | Class II | Open, Classified | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.Distribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV. | 211 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-21 | 3031658894-2026-00007 | Injury | Available | exact di |
| 2026-05-21 | 3031658894-2026-00008 | Malfunction | Available | exact di |
| 2025-12-15 | 3032814119-2025-00029 | Malfunction | Available | exact di |
| 2025-12-15 | 3032814119-2025-00033 | Malfunction | Available | exact di |
| 2025-11-04 | 3032814119-2025-00021 | Malfunction | Available | exact di |
Regulatory clearances
- PMAP24002930-day notice accepted (OK30) · 2026-03-16 · +2 earlier decisionsclearance family
Manufacturer compliance record
None in the loaded window.
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