Official recall notice
FDA DeviceClass IINotable
FDA Recall: Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0S
- Recall date
- 2026-04-29
- Brand
- Angiodynamics, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Recommended action
What to do
320 units (64 boxes)
Product description
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.