FDA Device recall Z-2454-2024
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis
- FDA Device
- Class II
- ongoing
- Published 2024-08-07
On 2024-08-07 the FDA classified a Class II recall of SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis by Angiodynamics, citing mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter lengt….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2454-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-18 |
| Published | 2024-08-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Angiodynamics |
| Distribution | US |
Product
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Reason
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Identifiers
| code_info | UPN: H787107327015 UDI-DI: 25051684009772 (Box) 15051684009775 (Pouch) Lot Number: A0424031 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2454-2024%22
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