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
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-02-21 | NAI | No action indicated | Volcano Corp | 0 |
Similar devices
- ALN 2in1 A.L.N.
- ALN Optional Vena Cava Filter - Brachial Approach A.L.N.
- ALN Optional Vena Cava Filter - Brachial Approach with Hook A.L.N.
- ALN Optional Vena Cava Filter - Femoral Approach A.L.N.
- ALN Optional Vena Cava Filter - Femoral Approach with Hook A.L.N.
- ALN Optional Vena Cava Filter - Jugular Approach A.L.N.
- ALN Optional Vena Cava Filter - Jugular Approach with Hook A.L.N.
- ALN Pre-Curved RS A.L.N.
- ALN Straight RS A.L.N.
- Cook Celect William Cook Europe ApS
- Cook Celect William Cook Europe ApS
- Cook Celect William Cook Europe ApS
Select up to two to place side-by-side with this device.