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.
188 linked reportsMalfunction 170Injury 18
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 4 | 2 |
| 2019-02 | 0 | 3.67 |
| 2019-03 | 1 | 1.67 |
| 2019-04 | 2 | 2 |
| 2019-05 | 1 | 2.11 |
| 2019-06 | 1 | 1.29 |
| 2019-07 | 0 | 2.8 |
| 2019-08 | 2 | 1.78 |
| 2019-09 | 1 | 1.13 |
| 2019-10 | 1 | 1.5 |
| 2019-11 | 0 | 1.2 |
| 2019-12 | 1 | 2 |
| 2020-01 | 0 | 1 |
| 2020-02 | 2 | 2.5 |
| 2020-03 | 0 | 3.14 |
| 2020-04 | 0 | 6.2 |
| 2020-05 | 0 | 6.8 |
| 2020-06 | 0 | 6.63 |
| 2020-07 | 0 | 10.57 |
| 2020-08 | 2 | 8.78 |
| 2020-09 | 0 | 20.25 |
| 2020-10 | 0 | 11.43 |
| 2020-11 | 0 | 17 |
| 2020-12 | 0 | 16 |
| 2021-01 | 1 | 8.89 |
| 2021-02 | 0 | 16.5 |
| 2021-03 | 0 | 40.2 |
| 2021-04 | 0 | 21.3 |
| 2021-05 | 2 | 15.25 |
| 2021-06 | 0 | 9.83 |
| 2021-07 | 0 | 20.57 |
| 2021-08 | 0 | 15.5 |
| 2021-09 | 0 | 10.67 |
| 2021-10 | 0 | 7.82 |
| 2021-11 | 0 | 14.17 |
| 2021-12 | 0 | 16.25 |
| 2022-01 | 0 | 8.09 |
| 2022-02 | 4 | 15.25 |
| 2022-03 | 8 | 9.5 |
| 2022-04 | 0 | 9.45 |
| 2022-05 | 1 | 18.33 |
| 2022-06 | 0 | 21.83 |
| 2022-07 | 0 | 9.75 |
| 2022-08 | 6 | 9.86 |
| 2022-09 | 1 | 8.7 |
| 2022-10 | 0 | 8.67 |
| 2022-11 | 1 | 5.44 |
| 2022-12 | 4 | 7.58 |
| 2023-01 | 3 | 8.12 |
| 2023-02 | 6 | 13 |
| 2023-03 | 4 | 9.13 |
| 2023-04 | 9 | 5.61 |
| 2023-05 | 0 | 7.5 |
| 2023-06 | 3 | 6.74 |
| 2023-07 | 0 | 11.43 |
| 2023-08 | 2 | 8 |
| 2023-09 | 0 | 11.67 |
| 2023-10 | 0 | 9.53 |
| 2023-11 | 3 | 10.6 |
| 2023-12 | 4 | 12.38 |
| 2024-01 | 3 | 20.36 |
| 2024-02 | 2 | 10.35 |
| 2024-03 | 5 | 10.85 |
| 2024-04 | 2 | 10.73 |
| 2024-05 | 2 | 8.69 |
| 2024-06 | 2 | 11.31 |
| 2024-07 | 1 | 7.59 |
| 2024-08 | 0 | 10.64 |
| 2024-09 | 5 | 11.29 |
| 2024-10 | 6 | 11.72 |
| 2024-11 | 0 | 5.7 |
| 2024-12 | 0 | 3 |
| 2025-01 | 0 | 5.44 |
| 2025-02 | 0 | 3.73 |
| 2025-03 | 4 | 5.86 |
| 2025-04 | 0 | 4.13 |
| 2025-05 | 11 | 4.36 |
| 2025-06 | 0 | 5.88 |
| 2025-07 | 6 | 4.36 |
| 2025-08 | 6 | 7 |
| 2025-09 | 0 | 9.29 |
| 2025-10 | 3 | 8.62 |
| 2025-11 | 12 | 13.82 |
| 2025-12 | 3 | 23.25 |
| 2026-01 | 3 | 25.15 |
| 2026-02 | 6 | 17.9 |
| 2026-03 | 12 | 17.63 |
| 2026-04 | 10 | 39.14 |
| 2026-05 | 3 | 42.36 |
| 2026-06 | 1 | 43 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-11-13 | Z-0617-2024 | Class II | Open, Classified | Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.Distribution: Domestic distribution nationwide. Foreign distribution to Australia Canada China Hong Kong Italy Malaysia Netherlands New Zealand Singapore Thailand | 2545 US; 992 OUS | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-05 | 2150060-2026-00026 | Malfunction | Available | procode brand trgm |
| 2026-05-21 | 2150060-2026-00021 | Malfunction | Available | exact di |
| 2026-04-29 | 2150060-2026-00019 | Malfunction | Available | procode brand trgm |
| 2026-04-29 | 2150060-2026-00018 | Malfunction | Available | exact di |
| 2026-04-23 | 2150060-2026-00017 | Malfunction | Available | exact di |
| 2026-04-21 | 2150060-2026-00016 | Malfunction | Available | exact di |
| 2026-03-26 | 2150060-2026-00014 | Malfunction | Available | exact di |
| 2026-03-26 | 2150060-2026-00013 | Malfunction | Available | exact di |
| 2026-03-18 | 2150060-2026-00012 | Malfunction | Available | exact di |
| 2026-03-04 | 2150060-2026-00008 | Malfunction | Available | exact di |
| 2026-02-20 | 2150060-2026-00006 | Malfunction | Available | exact di |
| 2026-02-06 | 2150060-2026-00005 | Malfunction | Available | exact di |
| 2026-01-09 | 2150060-2026-00003 | Malfunction | Available | exact di |
| 2025-12-19 | 2150060-2025-00043 | Malfunction | Available | exact di |
| 2025-11-28 | 2150060-2025-00040 | Malfunction | Available | exact di |
Showing the most recent 89 of 188 linked reports.
Showing 1–15 of 89
Regulatory clearances
Predicate lineage
K102996
Cited as predicate by: K172677
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 |
|---|---|---|---|---|
| 2017-03-31 | NAI | No action indicated | Medivators Inc | 0 |
| 2015-05-12 | VAI | Voluntary action indicated | Medivators, Inc. | 4 |
| 2014-07-31 | NAI | No action indicated | Medivators, Inc. | 0 |
| 2012-12-17 | VAI | Voluntary action indicated | Medivators Inc | 7 |
| 2011-08-26 | VAI | Voluntary action indicated | Medivators, Inc. | 0 |
| 2010-07-12 | VAI | Voluntary action indicated | Medivators, Inc. | 3 |
| 2010-06-04 | VAI | Voluntary action indicated | Medivators, Inc. | 4 |
| 2010-04-13 | VAI | Voluntary action indicated | Medivators Inc | 9 |
| 2009-07-31 | WL | Warning Letter | Medivators Inc | — |
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