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.
7 linked reportsMalfunction 7
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.6 |
| 2019-02 | 0 | 1.33 |
| 2019-03 | 0 | 1.55 |
| 2019-04 | 0 | 1.2 |
| 2019-05 | 0 | 1.43 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 1.17 |
| 2019-08 | 0 | 1.6 |
| 2019-09 | 0 | 1.8 |
| 2019-10 | 0 | 1.75 |
| 2019-11 | 0 | 2.17 |
| 2019-12 | 0 | 1.45 |
| 2020-01 | 0 | 2 |
| 2020-02 | 0 | 2.88 |
| 2020-03 | 0 | 2.09 |
| 2020-04 | 0 | 4.43 |
| 2020-05 | 0 | 4.83 |
| 2020-06 | 0 | 2.78 |
| 2020-07 | 0 | 3.75 |
| 2020-08 | 0 | 2.73 |
| 2020-09 | 0 | 2.64 |
| 2020-10 | 0 | 4.25 |
| 2020-11 | 0 | 3 |
| 2020-12 | 0 | 2.2 |
| 2021-01 | 0 | 2.91 |
| 2021-02 | 0 | 3.2 |
| 2021-03 | 0 | 5.33 |
| 2021-04 | 0 | 4.22 |
| 2021-05 | 0 | 3.89 |
| 2021-06 | 0 | 2.44 |
| 2021-07 | 0 | 3.22 |
| 2021-08 | 0 | 3 |
| 2021-09 | 0 | 1.86 |
| 2021-10 | 0 | 2.43 |
| 2021-11 | 0 | 1.67 |
| 2021-12 | 0 | 8.4 |
| 2022-01 | 0 | 6.75 |
| 2022-02 | 0 | 7.13 |
| 2022-03 | 0 | 3.83 |
| 2022-04 | 0 | 4.25 |
| 2022-05 | 0 | 2.83 |
| 2022-06 | 0 | 2.5 |
| 2022-07 | 0 | 2.2 |
| 2022-08 | 0 | 6 |
| 2022-09 | 0 | 4.67 |
| 2022-10 | 0 | 11.36 |
| 2022-11 | 0 | 4.29 |
| 2022-12 | 0 | 2.17 |
| 2023-01 | 0 | 3.67 |
| 2023-02 | 0 | 3.14 |
| 2023-03 | 0 | 8.2 |
| 2023-04 | 0 | 10.4 |
| 2023-05 | 0 | 7.2 |
| 2023-06 | 0 | 6 |
| 2023-07 | 6 | 4.63 |
| 2023-08 | 0 | 4.1 |
| 2023-09 | 0 | 3.8 |
| 2023-10 | 0 | 5.63 |
| 2023-11 | 0 | 12.2 |
| 2023-12 | 0 | 7.5 |
| 2024-01 | 0 | 16.4 |
| 2024-02 | 0 | 7.6 |
| 2024-03 | 0 | 10.25 |
| 2024-04 | 0 | 24 |
| 2024-05 | 0 | 13.5 |
| 2024-06 | 0 | 4.75 |
| 2024-07 | 0 | 3.56 |
| 2024-08 | 0 | 4.2 |
| 2024-09 | 0 | 7.29 |
| 2024-10 | 0 | 6.33 |
| 2024-11 | 0 | 9 |
| 2024-12 | 0 | 5.33 |
| 2025-01 | 0 | 8.29 |
| 2025-02 | 0 | 7.17 |
| 2025-03 | 0 | 9.5 |
| 2025-04 | 0 | 3.67 |
| 2025-05 | 1 | 4.33 |
| 2025-06 | 0 | 2.5 |
| 2025-07 | 0 | 4.5 |
| 2025-08 | 0 | 4.29 |
| 2025-09 | 0 | 1.17 |
| 2025-10 | 0 | 3.67 |
| 2025-11 | 0 | 1.83 |
| 2025-12 | 0 | 1.2 |
| 2026-01 | 0 | 1.33 |
| 2026-02 | 0 | 2.44 |
| 2026-03 | 0 | 3.5 |
| 2026-04 | 0 | 2.14 |
| 2026-05 | 0 | 1.43 |
| 2026-06 | 0 | 2 |
Failure-mode summaryAI-generated
7 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-04-22 | Z-2231-2025 | Class II | Open, Classified | Notice was issued to clarify flow rates related to the inlet fluid temperature.Distribution: US (nationwide) and Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Luxembourg, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam. | 186,880 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-05-21 | MW5170688 | Malfunction | Available | model number |
| 2023-07-24 | 17375771 | Malfunction | Available | catalog number |
| 2023-07-24 | 17375781 | Malfunction | Available | catalog number |
| 2023-07-07 | 17277392 | Malfunction | Available | catalog number |
Showing the most recent 4 of 7 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-06-24 | NAI | No action indicated | 3m Company | 0 |
| 2026-06-24 | NAI | No action indicated | 3m Company | 0 |
| 2019-04-17 | VAI | Voluntary action indicated | 3M | 4 |
| 2017-11-27 | NAI | No action indicated | 3M Company | 0 |
| 2016-12-08 | NAI | No action indicated | 3M Company | 0 |
| 2016-12-08 | NAI | No action indicated | 3M Company | 0 |
| 2016-12-06 | NAI | No action indicated | 3M Company | 0 |
| 2016-09-14 | NAI | No action indicated | 3M Company | 0 |
| 2015-11-06 | VAI | Voluntary action indicated | 3M Company | 1 |
| 2015-03-19 | OAI | Official action indicated | 3m Canada Company | 5 |
| 2014-07-09 | NAI | No action indicated | 3M Co | 0 |
| 2014-07-09 | NAI | No action indicated | 3M Co | 0 |
| 2014-06-26 | NAI | No action indicated | 3M Company | 0 |
| 2014-06-26 | NAI | No action indicated | 3M Company | 0 |
| 2014-04-25 | NAI | No action indicated | 3M Company | 0 |
| 2013-12-13 | NAI | No action indicated | 3M Company | 0 |
| 2013-08-16 | NAI | No action indicated | 3m Company | 0 |
| 2013-08-16 | NAI | No action indicated | 3m Company | 0 |
| 2013-03-28 | NAI | No action indicated | 3M Company | 1 |
| 2012-12-05 | NAI | No action indicated | 3M COMPANY | 0 |
| 2010-06-07 | WL | Warning Letter | 3M Company | — |
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