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.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-02-20 | Z-1603-2020 | Class II | Terminated | A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.Distribution: Domestic distribution only to the following states: AL AZ CA CT FL GA IL MA MI NC NH NM NY OH OK TN TX VA | 255 | clearance family |
Regulatory clearances
Predicate lineage
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 |
|---|---|---|---|---|
| 2022-06-24 | OAI | Official action indicated | Maquet Cardiopulmonary GmbH | 5 |
| 2022-06-24 | OAI | Official action indicated | Maquet Cardiopulmonary GmbH | 5 |
| 2022-04-28 | NAI | No action indicated | Maquet Cardiopulmonary Gmbh | 0 |
| 2022-04-28 | NAI | No action indicated | Maquet Cardiopulmonary Gmbh | 0 |
| 2014-12-04 | WL | Warning Letter | Maquet Cardiopulmonary Gmbh | — |
| 2014-12-04 | WL | Warning Letter | Maquet Cardiopulmonary Gmbh | — |
| 2014-01-10 | VAI | Voluntary action indicated | Maquet Cardiopulmonary Ag | 3 |
| 2013-09-26 | OAI | Official action indicated | Maquet Cardiopulmonary Gmbh | 0 |
| 2013-09-26 | OAI | Official action indicated | Maquet Cardiopulmonary Gmbh | 0 |
| 2013-09-23 | OAI | Official action indicated | Maquet Cardiopulmonary GmbH | 0 |
| 2013-09-23 | OAI | Official action indicated | Maquet Cardiopulmonary GmbH | 0 |
| 2013-08-15 | OAI | Official action indicated | Maquet Cardiopulmonary GmbH | 0 |
| 2013-08-15 | OAI | Official action indicated | Maquet Cardiopulmonary GmbH | 0 |
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