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.
36 linked reportsMalfunction 33Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 11.13 |
| 2019-02 | 0 | 4.13 |
| 2019-03 | 0 | 2.6 |
| 2019-04 | 0 | 3.54 |
| 2019-05 | 0 | 7.38 |
| 2019-06 | 0 | 41.85 |
| 2019-07 | 0 | 9.24 |
| 2019-08 | 0 | 63.43 |
| 2019-09 | 2 | 30.31 |
| 2019-10 | 0 | 11.12 |
| 2019-11 | 0 | 33.61 |
| 2019-12 | 0 | 46.68 |
| 2020-01 | 0 | 42.17 |
| 2020-02 | 0 | 34.08 |
| 2020-03 | 0 | 137.06 |
| 2020-04 | 1 | 64.38 |
| 2020-05 | 0 | 33.55 |
| 2020-06 | 0 | 66.13 |
| 2020-07 | 0 | 57.25 |
| 2020-08 | 0 | 33.63 |
| 2020-09 | 0 | 40.24 |
| 2020-10 | 0 | 22.5 |
| 2020-11 | 0 | 28.13 |
| 2020-12 | 0 | 15.74 |
| 2021-01 | 0 | 20.28 |
| 2021-02 | 0 | 12.97 |
| 2021-03 | 0 | 12.7 |
| 2021-04 | 2 | 9.2 |
| 2021-05 | 0 | 4.29 |
| 2021-06 | 0 | 4.73 |
| 2021-07 | 0 | 5.88 |
| 2021-08 | 0 | 6.48 |
| 2021-09 | 0 | 10.65 |
| 2021-10 | 0 | 5.43 |
| 2021-11 | 2 | 4.23 |
| 2021-12 | 0 | 7.62 |
| 2022-01 | 0 | 6.9 |
| 2022-02 | 0 | 8.39 |
| 2022-03 | 0 | 5.7 |
| 2022-04 | 0 | 3.76 |
| 2022-05 | 0 | 3 |
| 2022-06 | 0 | 2.68 |
| 2022-07 | 4 | 3.74 |
| 2022-08 | 3 | 3.95 |
| 2022-09 | 0 | 5.42 |
| 2022-10 | 0 | 5.95 |
| 2022-11 | 0 | 3.96 |
| 2022-12 | 0 | 5.74 |
| 2023-01 | 3 | 3.73 |
| 2023-02 | 2 | 6.29 |
| 2023-03 | 3 | 5.15 |
| 2023-04 | 0 | 6.26 |
| 2023-05 | 0 | 5.15 |
| 2023-06 | 0 | 5.86 |
| 2023-07 | 0 | 4.95 |
| 2023-08 | 0 | 5.79 |
| 2023-09 | 0 | 4.77 |
| 2023-10 | 0 | 8.78 |
| 2023-11 | 3 | 7.22 |
| 2023-12 | 0 | 7.63 |
| 2024-01 | 0 | 9.97 |
| 2024-02 | 0 | 5.16 |
| 2024-03 | 0 | 4.15 |
| 2024-04 | 0 | 7.54 |
| 2024-05 | 0 | 5.44 |
| 2024-06 | 0 | 11.85 |
| 2024-07 | 0 | 6.11 |
| 2024-08 | 0 | 10.25 |
| 2024-09 | 0 | 13.25 |
| 2024-10 | 0 | 6.5 |
| 2024-11 | 0 | 4.24 |
| 2024-12 | 0 | 5.88 |
| 2025-01 | 0 | 4.57 |
| 2025-02 | 0 | 6.66 |
| 2025-03 | 0 | 11.29 |
| 2025-04 | 0 | 8.63 |
| 2025-05 | 4 | 8.45 |
| 2025-06 | 0 | 6.93 |
| 2025-07 | 0 | 6.06 |
| 2025-08 | 0 | 12.38 |
| 2025-09 | 0 | 6.9 |
| 2025-10 | 0 | 5.83 |
| 2025-11 | 0 | 8.5 |
| 2025-12 | 0 | 9.26 |
| 2026-01 | 4 | 15.75 |
| 2026-02 | 2 | 16.68 |
| 2026-03 | 0 | 11.69 |
| 2026-04 | 1 | 15.03 |
| 2026-05 | 0 | 15.8 |
| 2026-06 | 0 | 23.48 |
Failure-mode summaryAI-generated
36 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-07-02 | Z-3192-2024 | Class II | Open, Classified | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.Distribution: Worldwide - US Nationwide distribution including in the states of AZ, FL, OH, NY, MO, CO, IL, NC, CA, AK, PA, MN, ND, TX, SC, AR, WI, OK, TN, KS, UT, NJ, VA, MA, KY, IN, AL, DE, MT, NE, WV, NV, HI, OR, WA, NH, LA, CT, MI, GA, MD, ID, MS, IA, RI, NM, VT and the countries of ITA, TUN, ROU, LTU, BEL, GBR, CAN, TUR, POL, PAN, THA, PRT, TWN, AUT, NZL, AUS, BGR, MEX, CHE, NLD, PHL, PER, FRA, SGP, ZAF, CZE, EST, ESP, OMN, NPL, COL, PRI, ISR, JPN, KEN, BHR, ARE, CHN. | 95,430 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-24 | 24980710 | Malfunction | Available | catalog number |
| 2026-02-10 | 24303069 | Malfunction | Available | catalog number |
| 2026-01-29 | 0001625425-2026-00930 | Malfunction | Available | exact di |
| 2026-01-22 | 24144090 | Malfunction | Available | catalog number |
| 2025-05-19 | 0001625425-2025-01017 | Malfunction | Available | exact di |
| 2025-05-06 | 21967395 | Malfunction | Available | catalog number |
| 2023-11-20 | 18169134 | Malfunction | Available | catalog number |
| 2023-03-13 | 0001625425-2023-00998 | Malfunction | Available | catalog number |
| 2023-02-06 | MW5114749 | Malfunction | Available | catalog number |
| 2023-01-24 | 0001625425-2023-00943 | Malfunction | Available | catalog number |
| 2022-08-29 | 0001625425-2022-01078 | Malfunction | Available | catalog number |
| 2022-07-28 | 15121196 | Malfunction | Available | catalog number |
| 2022-07-28 | 15121161 | Malfunction | Available | catalog number |
| 2021-11-02 | MW5105107 | Malfunction | Available | catalog number |
| 2021-04-12 | MW5100712 | Malfunction | Available | catalog number |
Showing the most recent 18 of 36 linked reports.
Showing 1–15 of 18
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2021-11-04 | NAI | No action indicated | Argon Medical Devices, Inc | 0 |
| 2021-11-04 | NAI | No action indicated | Argon Medical Devices, Inc | 0 |
| 2016-05-27 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 2 |
| 2016-05-27 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 2 |
| 2016-05-04 | NAI | No action indicated | Argon Medical Devices Inc. | 0 |
| 2016-05-04 | NAI | No action indicated | Argon Medical Devices Inc. | 0 |
| 2014-07-03 | WL | Warning Letter | Argon Medical Devices, Inc | — |
| 2014-07-03 | WL | Warning Letter | Argon Medical Devices, Inc | — |
| 2013-12-13 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 3 |
| 2013-12-13 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 3 |
| 2012-01-18 | VAI | Voluntary action indicated | Argon Medical Devices Inc. | 3 |
| 2012-01-18 | VAI | Voluntary action indicated | Argon Medical Devices Inc. | 3 |
| 2011-05-18 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 1 |
| 2011-05-18 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 1 |
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