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 reportsMalfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 2 |
| 2019-12 | 0 | 2 |
| 2021-08 | 0 | 1 |
| 2021-11 | 2 | 2 |
| 2023-08 | 0 | 1 |
| 2023-11 | 0 | 1 |
| 2024-03 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 1 |
| 2024-10 | 0 | 1.5 |
| 2024-11 | 0 | 1 |
| 2025-01 | 0 | 1 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 1.5 |
| 2025-05 | 0 | 1.5 |
| 2025-07 | 0 | 1.5 |
| 2025-08 | 0 | 1.33 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 1.6 |
| 2025-12 | 0 | 1.67 |
| 2026-03 | 0 | 3 |
| 2026-05 | 0 | 3 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2021-11-30 | 12891626 | Malfunction | Available | catalog number |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-04-24 | WL | Warning Letter | Cardinal Health 200, LLC | — |
| 2024-04-24 | WL | Warning Letter | Cardinal Health 200, LLC | — |
| 2023-12-20 | OAI | Official action indicated | Cardinal Health 200, LLC | 3 |
| 2023-12-20 | OAI | Official action indicated | Cardinal Health 200, LLC | 3 |
| 2023-10-26 | VAI | Voluntary action indicated | Aero-Med LLC | 2 |
| 2023-05-05 | NAI | No action indicated | Cardinal Health 200, LLC | 0 |
| 2023-05-05 | NAI | No action indicated | Cardinal Health 200, LLC | 0 |
| 2023-01-12 | NAI | No action indicated | Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) | 0 |
| 2020-02-19 | NAI | No action indicated | Cardinal Health Inc. | 0 |
| 2018-12-21 | VAI | Voluntary action indicated | Aero-Med LLC | 2 |
| 2017-11-15 | VAI | Voluntary action indicated | Cardinal Health LLC | 1 |
| 2017-07-13 | NAI | No action indicated | Cardinal Health D.R. 203 II LTD | 0 |
| 2017-01-25 | VAI | Voluntary action indicated | Cardinal Health | 4 |
| 2016-11-16 | NAI | No action indicated | Cardinal Health Ireland Manufacturing Limited | 0 |
| 2016-11-16 | VAI | Voluntary action indicated | Cardinal Health PR 218 Inc | 0 |
| 2016-08-25 | NAI | No action indicated | Cardinal Health 200, LLC | 0 |
| 2016-08-25 | NAI | No action indicated | Cardinal Health 200, LLC | 0 |
| 2016-08-23 | NAI | No action indicated | Cardinal Health 200, LLC | 0 |
| 2016-05-12 | VAI | Voluntary action indicated | Cardinal Health | 0 |
| 2016-03-23 | NAI | No action indicated | Cardinal Health LLC | 0 |
| 2016-01-28 | VAI | Voluntary action indicated | Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) | 2 |
| 2015-11-18 | NAI | No action indicated | Cardinal Health | 0 |
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