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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 10.56 |
| 2019-02 | 0 | 12.69 |
| 2019-03 | 0 | 11.63 |
| 2019-04 | 0 | 12.46 |
| 2019-05 | 0 | 12.27 |
| 2019-06 | 0 | 10.34 |
| 2019-07 | 0 | 11.67 |
| 2019-08 | 0 | 16.27 |
| 2019-09 | 0 | 12.2 |
| 2019-10 | 0 | 13.33 |
| 2019-11 | 0 | 16.63 |
| 2019-12 | 0 | 20.13 |
| 2020-01 | 0 | 14.15 |
| 2020-02 | 0 | 18.53 |
| 2020-03 | 0 | 17.04 |
| 2020-04 | 0 | 19.1 |
| 2020-05 | 0 | 30.98 |
| 2020-06 | 0 | 17.15 |
| 2020-07 | 0 | 24.74 |
| 2020-08 | 0 | 28.38 |
| 2020-09 | 0 | 74.85 |
| 2020-10 | 0 | 99.6 |
| 2020-11 | 0 | 192.07 |
| 2020-12 | 0 | 385.31 |
| 2021-01 | 0 | 264.09 |
| 2021-02 | 0 | 106.71 |
| 2021-03 | 0 | 77.38 |
| 2021-04 | 0 | 78.29 |
| 2021-05 | 0 | 72.41 |
| 2021-06 | 0 | 74.45 |
| 2021-07 | 0 | 89.1 |
| 2021-08 | 0 | 111.07 |
| 2021-09 | 0 | 151.73 |
| 2021-10 | 1 | 318.48 |
| 2021-11 | 0 | 385.2 |
| 2021-12 | 0 | 1212.16 |
| 2022-01 | 0 | 2694.92 |
| 2022-02 | 0 | 1413.28 |
| 2022-03 | 0 | 2239.43 |
| 2022-04 | 0 | 2411.59 |
| 2022-05 | 0 | 1936.71 |
| 2022-06 | 0 | 1803.15 |
| 2022-07 | 0 | 888.18 |
| 2022-08 | 0 | 227.64 |
| 2022-09 | 0 | 287.35 |
| 2022-10 | 0 | 256.49 |
| 2022-11 | 0 | 245.91 |
| 2022-12 | 0 | 228.98 |
| 2023-01 | 0 | 127.34 |
| 2023-02 | 0 | 255.75 |
| 2023-03 | 0 | 305.05 |
| 2023-04 | 0 | 263.63 |
| 2023-05 | 0 | 240.84 |
| 2023-06 | 0 | 298.8 |
| 2023-07 | 0 | 281.34 |
| 2023-08 | 0 | 268.34 |
| 2023-09 | 0 | 219.98 |
| 2023-10 | 0 | 129.77 |
| 2023-11 | 0 | 130.95 |
| 2023-12 | 0 | 63.55 |
| 2024-01 | 0 | 67.35 |
| 2024-02 | 0 | 101.17 |
| 2024-03 | 0 | 71.21 |
| 2024-04 | 0 | 76.75 |
| 2024-05 | 0 | 46.49 |
| 2024-06 | 0 | 50.21 |
| 2024-07 | 0 | 45.53 |
| 2024-08 | 0 | 41.36 |
| 2024-09 | 0 | 48.22 |
| 2024-10 | 0 | 50.88 |
| 2024-11 | 0 | 57.8 |
| 2024-12 | 0 | 53.16 |
| 2025-01 | 0 | 64.36 |
| 2025-02 | 0 | 57.67 |
| 2025-03 | 0 | 83.62 |
| 2025-04 | 0 | 71.4 |
| 2025-05 | 0 | 81.16 |
| 2025-06 | 0 | 87.33 |
| 2025-07 | 0 | 119.88 |
| 2025-08 | 0 | 83.67 |
| 2025-09 | 0 | 81.89 |
| 2025-10 | 0 | 93.65 |
| 2025-11 | 0 | 83 |
| 2025-12 | 0 | 88.56 |
| 2026-01 | 0 | 74.52 |
| 2026-02 | 0 | 76.73 |
| 2026-03 | 0 | 87.13 |
| 2026-04 | 0 | 143.63 |
| 2026-05 | 0 | 327.5 |
| 2026-06 | 0 | 351.16 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-03-31 | Z-1678-2025 | Class II | Open, Classified | Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.Distribution: Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI. International distribution to Czechia, Italy, Norway. | 603 cases (2,412 sets) | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2021-10-14 | 1219702-2021-00126 | Malfunction | Available | exact di |
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2013-06-21 | VAI | Voluntary action indicated | Belmont Instrument LLC | 2 |
| 2013-06-21 | VAI | Voluntary action indicated | Belmont Instrument LLC | 2 |
| 2012-05-07 | WL | Warning Letter | Belmont Instrument LLC | — |
| 2012-05-07 | WL | Warning Letter | Belmont Instrument LLC | — |
| 2011-04-27 | VAI | Voluntary action indicated | Belmont Instrument LLC | 3 |
| 2011-04-27 | VAI | Voluntary action indicated | Belmont Instrument LLC | 3 |
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