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.
23 linked reportsMalfunction 23
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-03 | 0 | 2 |
| 2019-05 | 0 | 1 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 1.5 |
| 2019-10 | 0 | 1.5 |
| 2019-12 | 0 | 2 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 1 |
| 2020-07 | 0 | 3 |
| 2020-08 | 0 | 2 |
| 2020-09 | 0 | 1.33 |
| 2020-10 | 0 | 2.5 |
| 2020-11 | 0 | 2 |
| 2020-12 | 0 | 1.67 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 5 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-11 | 0 | 1.57 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 2 |
| 2022-04 | 0 | 1.5 |
| 2022-06 | 0 | 2 |
| 2022-08 | 0 | 5 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 1.33 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 2 |
| 2023-04 | 0 | 6 |
| 2023-05 | 11 | 4.67 |
| 2023-07 | 8 | 8 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2024-01 | 0 | 2.33 |
| 2024-02 | 0 | 3.13 |
| 2024-03 | 4 | 4.25 |
| 2024-04 | 0 | 1.8 |
| 2024-05 | 0 | 1.28 |
| 2024-06 | 0 | 3 |
| 2024-07 | 0 | 2.33 |
| 2024-08 | 0 | 4 |
| 2024-09 | 0 | 2.25 |
| 2024-10 | 0 | 1.5 |
| 2024-11 | 0 | 1.33 |
| 2024-12 | 0 | 2 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 1 |
| 2025-06 | 0 | 2 |
| 2025-09 | 0 | 1.17 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 3 |
| 2026-03 | 0 | 1.5 |
| 2026-04 | 0 | 1.67 |
| 2026-05 | 0 | 2.44 |
| 2026-06 | 0 | 3 |
Failure-mode summaryAI-generated
23 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-06-28 | Z-2271-2023 | Class II | Open, Classified | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.Distribution: Worldwide distribution - US Nationwide and the countries of Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and United Arab Emirates. | 785 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-03-08 | 2242352-2024-00222 | Malfunction | Available | catalog number |
| 2023-07-26 | 2242352-2023-00605 | Malfunction | Available | catalog number |
| 2023-07-26 | 2242352-2023-00607 | Malfunction | Available | catalog number |
| 2023-05-19 | 2242352-2023-00390 | Malfunction | Available | catalog number |
| 2023-05-12 | 2242352-2023-00385 | Malfunction | Available | catalog number |
| 2023-05-03 | 2242352-2023-00347 | Malfunction | Available | catalog number |
Showing the most recent 6 of 23 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-07-11 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 11 |
| 2024-07-11 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 11 |
| 2021-02-26 | VAI | Voluntary action indicated | Maquet Cardiovascular, LLC | 10 |
| 2021-02-26 | VAI | Voluntary action indicated | Maquet Cardiovascular, LLC | 10 |
| 2019-09-19 | VAI | Voluntary action indicated | INTERVASCULAR, SAS | 3 |
| 2016-09-29 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 16 |
| 2016-09-29 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 16 |
| 2015-06-18 | NAI | No action indicated | INTERVASCULAR, SAS | 0 |
| 2013-10-16 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 17 |
| 2013-10-16 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 17 |
| 2012-06-14 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 14 |
| 2012-06-14 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 14 |
| 2011-04-01 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 13 |
| 2011-04-01 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 13 |
| 2010-08-11 | WL | Warning Letter | Maquet Cardiovascular, LLC | — |
| 2010-08-11 | WL | Warning Letter | Maquet Cardiovascular, LLC | — |
| 2010-06-28 | NAI | No action indicated | Maquet Cardiovascular | 0 |
| 2010-05-14 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 5 |
| 2010-05-14 | OAI | Official action indicated | Maquet Cardiovascular, LLC | 5 |
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