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.
16 linked reportsMalfunction 14Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.56 |
| 2019-02 | 0 | 3.14 |
| 2019-03 | 0 | 2.33 |
| 2019-04 | 0 | 2.5 |
| 2019-05 | 0 | 2.08 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 2.1 |
| 2019-08 | 0 | 4.57 |
| 2019-09 | 0 | 2.07 |
| 2019-10 | 0 | 3.33 |
| 2019-11 | 0 | 3.2 |
| 2019-12 | 0 | 3.1 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 2.18 |
| 2020-03 | 0 | 3 |
| 2020-04 | 0 | 2.6 |
| 2020-05 | 0 | 3.9 |
| 2020-06 | 0 | 3 |
| 2020-07 | 0 | 2.83 |
| 2020-08 | 0 | 2.11 |
| 2020-09 | 0 | 2 |
| 2020-10 | 0 | 2.52 |
| 2020-11 | 0 | 2.72 |
| 2020-12 | 0 | 2.58 |
| 2021-01 | 0 | 2.09 |
| 2021-02 | 0 | 2.63 |
| 2021-03 | 0 | 2.17 |
| 2021-04 | 0 | 2.59 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 3.11 |
| 2021-07 | 0 | 3.5 |
| 2021-08 | 0 | 1.56 |
| 2021-09 | 0 | 2 |
| 2021-10 | 0 | 2.75 |
| 2021-11 | 0 | 1.94 |
| 2021-12 | 0 | 2.86 |
| 2022-01 | 0 | 1.71 |
| 2022-02 | 0 | 2.7 |
| 2022-03 | 0 | 3.67 |
| 2022-04 | 2 | 2.59 |
| 2022-05 | 0 | 2.5 |
| 2022-06 | 0 | 4.13 |
| 2022-07 | 0 | 1.88 |
| 2022-08 | 0 | 3.36 |
| 2022-09 | 0 | 2.29 |
| 2022-10 | 0 | 2.29 |
| 2022-11 | 0 | 3.36 |
| 2022-12 | 0 | 3.14 |
| 2023-01 | 0 | 1.6 |
| 2023-02 | 2 | 3 |
| 2023-03 | 0 | 4.2 |
| 2023-04 | 6 | 4.1 |
| 2023-05 | 2 | 3.75 |
| 2023-06 | 0 | 3.29 |
| 2023-07 | 0 | 4.57 |
| 2023-08 | 0 | 2.41 |
| 2023-09 | 0 | 2.75 |
| 2023-10 | 0 | 2.18 |
| 2023-11 | 0 | 1.57 |
| 2023-12 | 0 | 2.33 |
| 2024-01 | 0 | 3.5 |
| 2024-02 | 0 | 3.63 |
| 2024-03 | 2 | 3.24 |
| 2024-04 | 0 | 1.86 |
| 2024-05 | 0 | 1.5 |
| 2024-06 | 0 | 3.9 |
| 2024-07 | 0 | 2.09 |
| 2024-08 | 0 | 2.33 |
| 2024-09 | 0 | 2 |
| 2024-10 | 0 | 1.83 |
| 2024-11 | 2 | 1.46 |
| 2024-12 | 0 | 2.1 |
| 2025-01 | 0 | 2.27 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 1.88 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 3.5 |
| 2025-06 | 0 | 1.87 |
| 2025-07 | 0 | 4.25 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 1.14 |
| 2025-10 | 0 | 2.89 |
| 2025-11 | 0 | 2.6 |
| 2025-12 | 0 | 2.75 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 1.8 |
| 2026-03 | 0 | 3.07 |
| 2026-04 | 0 | 4.88 |
| 2026-05 | 0 | 3.03 |
| 2026-06 | 0 | 4 |
Failure-mode summaryAI-generated
16 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-05-03 | Z-1994-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA. | 53,308 units (US: 11, 236; OUS: 42,072) | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-11-05 | 3011175548-2024-000024 | Injury | Available | exact di |
| 2024-03-07 | 3011175548-2024-00074 | Malfunction | Available | exact di |
| 2023-05-01 | 3011175548-2023-00104 | Malfunction | Available | exact di |
| 2023-04-30 | 3011175548-2023-00102 | Malfunction | Available | exact di |
| 2023-04-03 | 3011175548-2023-00091 | Malfunction | Available | exact di |
| 2023-04-03 | 3011175548-2023-00090 | Malfunction | Available | exact di |
| 2023-02-21 | 3011175548-2023-00065 | Malfunction | Available | exact di |
| 2022-04-19 | 3011175548-2022-00125 | Malfunction | Available | exact di |
Showing the most recent 8 of 16 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-11-26 | VAI | Voluntary action indicated | Atrium Medical Corporation | 8 |
| 2024-11-26 | VAI | Voluntary action indicated | Atrium Medical Corporation | 8 |
| 2022-09-06 | VAI | Voluntary action indicated | Atrium Medical Corporation | 0 |
| 2022-09-06 | VAI | Voluntary action indicated | Atrium Medical Corporation | 0 |
| 2020-02-10 | OAI | Official action indicated | Atrium Medical Corporation | 0 |
| 2020-02-10 | OAI | Official action indicated | Atrium Medical Corporation | 0 |
| 2018-08-02 | NAI | No action indicated | Atrium Medical Corporation | 0 |
| 2018-08-02 | NAI | No action indicated | Atrium Medical Corporation | 0 |
| 2016-07-13 | OAI | Official action indicated | Atrium Medical Corporation | 0 |
| 2016-07-13 | OAI | Official action indicated | Atrium Medical Corporation | 0 |
| 2016-01-08 | NAI | No action indicated | Atrium Medical Corporation | 0 |
| 2016-01-08 | NAI | No action indicated | Atrium Medical Corporation | 0 |
| 2013-10-01 | OAI | Official action indicated | Atrium Medical Corporation | 8 |
| 2013-10-01 | OAI | Official action indicated | Atrium Medical Corporation | 8 |
| 2012-10-11 | WL | Warning Letter | Atrium Medical Corporation | — |
| 2012-10-11 | WL | Warning Letter | Atrium Medical Corporation | — |
| 2012-09-07 | OAI | Official action indicated | Atrium Medical Corporation | 5 |
| 2012-09-07 | OAI | Official action indicated | Atrium Medical Corporation | 5 |
| 2010-03-15 | VAI | Voluntary action indicated | Atrium Medical Corporation | 0 |
| 2010-03-15 | VAI | Voluntary action indicated | Atrium Medical Corporation | 0 |
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