Official recall notice
FDA DeviceClass IINotable
FDA Recall: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.:
- 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
615 units (123 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.