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.
2 linked reportsInjury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-04 | 0 | 1.25 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 2 |
| 2019-08 | 0 | 1 |
| 2019-10 | 0 | 1.5 |
| 2019-12 | 0 | 1.25 |
| 2020-01 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-04 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 1.33 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 2.33 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 2 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1.33 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 1 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 2.75 |
| 2021-11 | 0 | 1.5 |
| 2021-12 | 0 | 3 |
| 2022-02 | 0 | 2 |
| 2022-03 | 0 | 1.5 |
| 2022-05 | 0 | 2 |
| 2022-07 | 0 | 1.5 |
| 2022-08 | 0 | 1.67 |
| 2022-09 | 0 | 1.43 |
| 2022-10 | 0 | 1.5 |
| 2022-11 | 0 | 3.8 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 1.8 |
| 2023-02 | 0 | 2.57 |
| 2023-03 | 0 | 4 |
| 2023-04 | 0 | 2.5 |
| 2023-05 | 0 | 1.36 |
| 2023-06 | 0 | 2.8 |
| 2023-07 | 0 | 1.25 |
| 2023-08 | 0 | 2.17 |
| 2023-09 | 0 | 3 |
| 2023-10 | 0 | 1.17 |
| 2023-11 | 0 | 1.5 |
| 2023-12 | 0 | 2 |
| 2024-01 | 0 | 1.2 |
| 2024-02 | 0 | 2.8 |
| 2024-03 | 0 | 2.83 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1.67 |
| 2024-06 | 0 | 1.67 |
| 2024-07 | 0 | 2 |
| 2024-08 | 0 | 2 |
| 2024-09 | 0 | 1.71 |
| 2024-11 | 0 | 2 |
| 2025-01 | 0 | 5 |
| 2025-02 | 0 | 2.5 |
| 2025-03 | 0 | 1.75 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 3 |
| 2025-06 | 0 | 3 |
| 2025-07 | 0 | 4.75 |
| 2025-08 | 0 | 4 |
| 2025-09 | 0 | 5.33 |
| 2025-10 | 0 | 9.25 |
| 2025-11 | 0 | 9 |
| 2025-12 | 0 | 8 |
| 2026-01 | 0 | 12 |
| 2026-02 | 2 | 4.14 |
| 2026-03 | 0 | 5.5 |
| 2026-04 | 0 | 4.4 |
| 2026-05 | 0 | 5.2 |
| 2026-06 | 0 | 6 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-09-15 | Z-0421-2021 | Class II | Terminated | Corrosion could cause performance failures in the product.Distribution: Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada). | 287,200 units | code info di |
| 2020-09-15 | Z-0422-2021 | Class II | Terminated | Corrosion could cause performance failures in the product.Distribution: Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada). | 10,145,050 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-02-06 | 2110898-2026-00005 | Injury | Available | catalog number |
Showing the most recent 1 of 2 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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